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Garvey ZP, Gupta A, Taylor N, Thirunavukkarasu M, Maulik N. Navigating Diabetes in Pregnancy: Critical Approaches to Mitigate Risks and Improve Outcomes for Mother and Child. Metabolites 2025; 15:180. [PMID: 40137145 PMCID: PMC11943762 DOI: 10.3390/metabo15030180] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/06/2024] [Revised: 02/05/2025] [Accepted: 02/14/2025] [Indexed: 03/27/2025] Open
Abstract
With the increasing prevalence of diabetes and its growing impact on maternal and fetal health, management during pregnancy has become critical. This review describes the pathophysiology of insulin resistance during pregnancy, adverse outcomes correlated with diabetic pregnancies, and current management strategies. We investigate two leading approaches to managing pregnant patients with diabetes-lifestyle intervention and drug treatment. Lifestyle intervention, including dietary counseling, exercise regimens, patient education, and self-administered blood glucose monitoring, has demonstrated promising results in the management and prevention of gestational diabetes mellitus (GDM). Early intervention and treatment of at-risk patients have been critical for positive outcomes. Drug treatment, focusing on the utilization of insulin, insulin analogs, and antihyperglycemic agents has shown efficacy in achieving glycemic control and improving maternal and neonatal outcomes. These findings indicate that a combination of early lifestyle intervention and targeted drug treatment yields the most benefit in managing diabetes in pregnancy. To augment treatment, continuous glucose monitoring and telemedicine have become valuable tools in managing diabetes during pregnancy. Future research should aim to develop more effective antihyperglycemic agents, improve telehealth accessibility, and enhance preconception care for women at risk of developing GDM. By addressing these areas, we can significantly reduce the adverse outcomes associated with diabetes in pregnancy and improve overall maternal and fetal health.
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Affiliation(s)
| | | | | | | | - Nilanjana Maulik
- Molecular Cardiology and Angiogenesis Laboratory, Department of Surgery, University of Connecticut School of Medicine, Farmington, CT 06030, USA; (Z.P.G.); (A.G.); (N.T.); (M.T.)
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2
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McCrea DL. Using Diabetes Technology in Hospitalized Patients. Crit Care Nurs Clin North Am 2025; 37:35-52. [PMID: 39890349 DOI: 10.1016/j.cnc.2024.07.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/03/2025]
Abstract
There is an estimated 350,000 persons wearing an insulin pump and 2.4 million wearing a continuous glucose monitor (CGM) sensor in the United States. The last few decades have ushered in advancements with the integration of insulin delivery and continuous glucose evaluations which offer a more precise tight insulin delivery and glycemic control. However, when hospital admissions are necessary, most desire to continue to wear their devices. The last several decades and during the pandemic, many agencies such as the Joint Commission, FDA, and diabetes organizations have generated position statements and guidelines to allow the most optimal diabetes treatment, even when hospitalized.
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Affiliation(s)
- Deborah L McCrea
- Department of Graduate Studies, UTHealth Houston, Cizik School of Nursing, 6901 Bertner, Suite 695, Houston, TX 77030, USA.
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McLean A, Maple-Brown L, Murphy HR. Technology advances in diabetes pregnancy: right technology, right person, right time. Diabetologia 2024; 67:2103-2113. [PMID: 38967667 PMCID: PMC11447080 DOI: 10.1007/s00125-024-06216-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/05/2024] [Accepted: 05/20/2024] [Indexed: 07/06/2024]
Abstract
This review outlines some of the extraordinary recent advances in diabetes technology, which are transforming the management of type 1 diabetes before, during and after pregnancy. It highlights recent improvements associated with use of continuous glucose monitoring (CGM) but acknowledges that neither CGM nor insulin pump therapy are adequate for achieving the pregnancy glucose targets. Furthermore, even hybrid closed-loop (HCL) systems that are clinically effective outside of pregnancy may not confer additional benefits throughout pregnancy. To date, there is only one HCL system, the CamAPS FX, with a strong evidence base for use during pregnancy, suggesting that the pregnancy benefits are HCL system specific. This is in stark contrast to HCL system use outside of pregnancy, where benefits are HCL category specific. The CamAPS FX HCL system has a rapidly adaptive algorithm and lower glucose targets with benefits across all maternal glucose categories, meaning that it is applicable for all women with type 1 diabetes, before and during pregnancy. For women of reproductive years living with type 2 diabetes, the relative merits of using non-insulin pharmacotherapies vs diabetes technology (dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter 2 inhibitors) are unknown. Despite the urgent unmet need and potential benefits, studies of pharmacotherapy and technology use are extremely limited in pregnant women with type 2 diabetes.
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Affiliation(s)
- Anna McLean
- Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia
- Endocrinology Department, Cairns Hospital, Cairns, Queensland, Australia
| | - Louise Maple-Brown
- Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia
- Endocrinology Department, Royal Darwin Hospital, Darwin, Northern Territory, Australia
| | - Helen R Murphy
- Norwich Medical School, University of East Anglia, Norwich, UK.
- Norfolk and Norwich NHS Foundation Trust, Diabetes and Antenatal Care, Norwich, UK.
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Bao Y, Xue M, Gohumpu J, Cao Y, Weng S, Fang P, Wu J, Yu B. Prenatal anxiety recognition model integrating multimodal physiological signal. Sci Rep 2024; 14:21767. [PMID: 39294387 PMCID: PMC11410974 DOI: 10.1038/s41598-024-72507-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/03/2024] [Accepted: 09/09/2024] [Indexed: 09/20/2024] Open
Abstract
Anxiety among pregnant women can significantly impact their overall well-being. However, the development of data-driven HCI interventions for this demographic is often hindered by data scarcity and collection challenges. In this study, we leverage the Empatica E4 wristband to gather physiological data from pregnant women in both resting and relaxed states. Additionally, we collect subjective reports on their anxiety levels. We integrate features from signals including Blood Volume Pulse (BVP), Skin Temperature (SKT), and Inter-Beat Interval (IBI). Employing a Support Vector Machine (SVM) algorithm, we construct a model capable of evaluating anxiety levels in pregnant women. Our model attains an emotion recognition accuracy of 69.3%, marking achievements in HCI technology tailored for this specific user group. Furthermore, we introduce conceptual ideas for biofeedback on maternal emotions and its interactive mechanism, shedding light on improved monitoring and timely intervention strategies to enhance the emotional health of pregnant women.
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Affiliation(s)
- Yanchi Bao
- Ningbo Innovation Center, Zhejiang University, Ningbo, China
| | - Mengru Xue
- Ningbo Innovation Center, Zhejiang University, Ningbo, China.
| | | | - Yumeng Cao
- Ningbo Innovation Center, Zhejiang University, Ningbo, China
| | - Shitong Weng
- Ningbo Innovation Center, Zhejiang University, Ningbo, China
| | - Peidi Fang
- The Affiliated People's Hospital of Ningbo University, Ningbo, China
| | - Jiang Wu
- University of Nottingham Ningbo China, Ningbo, China
| | - Bin Yu
- Nyenrode Business University, Breukelen, The Netherlands
- Amsterdam University of Applied Sciences, Amsterdam, The Netherlands
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Keeler Bruce L, González D, Dasgupta S, Smarr BL. Biometrics of complete human pregnancy recorded by wearable devices. NPJ Digit Med 2024; 7:207. [PMID: 39134787 PMCID: PMC11319646 DOI: 10.1038/s41746-024-01183-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/11/2023] [Accepted: 07/01/2024] [Indexed: 08/15/2024] Open
Abstract
In the United States, normal-risk pregnancies are monitored with the recommended average of 14 prenatal visits. Check-ins every few weeks are the standard of care. This low time resolution and reliance on subjective feedback instead of direct physiological measurement, could be augmented by remote monitoring. To date, continuous physiological measurements have not been characterized across all of pregnancy, so there is little basis of comparison to support the development of the specific monitoring capabilities. Wearables have been shown to enable the detection and prediction of acute illness, often faster than subjective symptom reporting. Wearables have also been used for years to monitor chronic conditions, such as continuous glucose monitors. Here we perform a retrospective analysis on multimodal wearable device data (Oura Ring) generated across pregnancy within 120 individuals. These data reveal clear trajectories of pregnancy from cycling to conception through postpartum recovery. We assessed individuals in whom pregnancy did not progress past the first trimester, and found associated deviations, corroborating that continuous monitoring adds new information that could support decision-making even in the early stages of pregnancy. By contrast, we did not find significant deviations between full-term pregnancies of people younger than 35 and of people with "advanced maternal age", suggesting that analysis of continuous data within individuals can augment risk assessment beyond standard population comparisons. Our findings demonstrate that low-cost, high-resolution monitoring at all stages of pregnancy in real-world settings is feasible and that many studies into specific demographics, risks, etc., could be carried out using this newer technology.
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Affiliation(s)
- Lauryn Keeler Bruce
- UC San Diego Health Department of Biomedical Informatics, University of California San Diego, San Diego, CA, USA
- Bioinformatics and Systems Biology, University of California San Diego, San Diego, CA, USA
| | - Dalila González
- Shu Chien-Gene Lay Department of Bioengineering, University of California San Diego, San Diego, CA, USA
| | - Subhasis Dasgupta
- San Diego Supercomputer Center, University of California San Diego, San Diego, CA, USA
| | - Benjamin L Smarr
- Shu Chien-Gene Lay Department of Bioengineering, University of California San Diego, San Diego, CA, USA.
- Halıcıoğlu Data Science Institute, University of California San Diego, San Diego, CA, USA.
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Gao V, Snell-Bergeon JK, Malecha E, Johnson CA, Polsky S. Clinical Effectiveness of Continuous Glucose Monitoring in Pregnancies Affected by Type 1 Diabetes. Diabetes Technol Ther 2024; 26:526-535. [PMID: 38386433 DOI: 10.1089/dia.2023.0548] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/24/2024]
Abstract
Background: Continuous glucose monitoring (CGM) improves neonatal outcomes in type 1 diabetes pregnancies; however, its effectiveness has not been assessed in a real-world setting in the United States. Objective: The Triple C Study aimed to examine the clinical effectiveness, assessed through maternal glucose control and gestational health outcomes, of CGM use compared with self-monitoring of blood glucose (SMBG) in pregnancies associated with type 1 diabetes in a real-world setting. Research Design and Methods: We retrospectively identified 160 type 1 diabetes pregnancies at the Barbara Davis Center for Diabetes managed with CGM therapy (n = 109) or SMBG (n = 51) over a 6.5-year period (2014-2020). Obstetric care was provided at multiple practices. CGM use was defined as ≥60% wear in the second and third trimesters of pregnancy. Data were obtained from the electronic medical record system, hospital records, and vital statistics departments (Colorado and Wyoming). We used Student's t-test for continuous variables and chi-square test for categorical variables to compare outcomes between groups. Results: The CGM group had more participants meeting trimester-specific hemoglobin A1C (HbA1c) goals throughout pregnancy and postpartum (P < 0.01 in each time period). The CGM group had fewer participants never meeting HbA1c goals in any trimester than the SMBG group (P < 0.001). There were no significant differences in neonatal outcomes between groups, other than for macrosomia (12.8% CGM vs. 29.4% SMBG, P = 0.01). Infants of CGM users required a neonatal intensive care unit admission less often (52.9% CGM vs. 68.3% SMBG, P = 0.0989). Conclusions: CGM use was associated with improved maternal glucose levels in a diverse real-world cohort.
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Affiliation(s)
- Valerie Gao
- Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA
| | - Janet K Snell-Bergeon
- Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA
| | - Emily Malecha
- Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA
| | - Carly A Johnson
- Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA
| | - Sarit Polsky
- Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA
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Bitar G, Cornthwaite JA, Sadek S, Ghorayeb T, Daye N, Nazeer S, Ghafir D, Cornthwaite J, Chauhan SP, Sibai BM, Fishel Bartal M. Continuous Glucose Monitoring and Time in Range: Association with Adverse Outcomes among People with Type 2 or Gestational Diabetes Mellitus. Am J Perinatol 2024; 41:e1370-e1377. [PMID: 36858069 DOI: 10.1055/s-0043-1764208] [Citation(s) in RCA: 5] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 03/03/2023]
Abstract
OBJECTIVE Continuous glucose monitoring (CGM) has become available for women with type 2 diabetes mellitus (T2DM) or gestational diabetes mellitus (GDM) during pregnancy. The recommended time in range (TIR, blood glucose 70-140 mg/dL) and its correlation with adverse pregnancy outcomes in this group is unknown. Our aim was to compare maternal and neonatal outcomes in pregnant people with T2DM or GDM with average CGM TIR values >70 versus ≤70%. STUDY DESIGN We conducted a retrospective cohort study of all individuals using CGM during pregnancy from January 2017 to June 2022. Individuals with type 1 diabetes mellitus, or those missing CGM or delivery data were excluded. Primary composite neonatal outcome included any of the following: large for gestational age, NICU admission, need for intravenous glucose, respiratory support, or neonatal death. Secondary outcomes included other maternal and neonatal outcomes. Regression models were used to estimate adjusted odds ratio (aOR) and 95% confidence interval (CI). RESULTS During the study period, 141 individuals with diabetes utilized CGM during pregnancy, with 65 (46%) meeting inclusion criteria. Of the study population, 28 (43%) had TIR ≤70% and 37 (57%) had TIR > 70%. Compared with those with TIR > 70%, the primary composite outcome occurred more frequently in neonates of individuals TIR ≤70% (71.4 vs. 37.8%, aOR: 4.8, 95% CI: 1.6, 15.7). Furthermore, individuals with TIR ≤70% were more likely to have hypertensive disorders (42.9 vs. 16.2%, OR: 3.9, 95% CI: 1.3, 13.0), preterm delivery (54 vs. 27%, OR: 3.1, 95% CI: 1.1, 9.1): , and cesarean delivery (96.4 vs. 51.4%, OR: 4.6, 95% CI: 2.2, 15.1) compared with those with TIR >70%. CONCLUSION Among people with T2DM or GDM who utilized CGM during pregnancy, 4 out 10 individuals had TIR ≤70% and, compared with those with TIR > 70%, they had a higher likelihood of adverse neonatal and maternal outcomes. KEY POINTS · Time in range can be utilized as a metric for pregnant patients using continuous glucose monitor.. · Time in range >70% is achievable by 6 out of 10 patients.. · Time in range below goal is associated with adverse neonatal and maternal outcomes..
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Affiliation(s)
- Ghamar Bitar
- Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas
| | - Joycelyn A Cornthwaite
- Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas
| | - Sandra Sadek
- Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas
| | - Tala Ghorayeb
- Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas
| | - Nahla Daye
- Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas
| | - Sarah Nazeer
- Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas
| | - Danna Ghafir
- Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas
| | - John Cornthwaite
- Department of Earth, Environmental and Planetary Science, Rice University, Houston, Texas
| | - Suneet P Chauhan
- Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas
| | - Baha M Sibai
- Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas
| | - Michal Fishel Bartal
- Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas
- Department of Obstetrics and Gynecology, Sheba Medical Center at Tel Hashomer, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
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Kaur RJ, Levy CJ, Castorino K, Wood-Wentz CM, Rizvi SR, Ozaslan B, O’Malley G, Trinidad MC, Levister C, Church MM, Desjardins D, Ogyaadu S, Reid C, Bailey KR, Doyle FJ, Pinsker JE, Dassau E, Kudva YC. Concordance of Blood Glucose and CGM During a Pilot Trial of Automated Insulin Delivery in Type 1 Diabetes Pregnancies. J Endocr Soc 2024; 8:bvae071. [PMID: 38721109 PMCID: PMC11077602 DOI: 10.1210/jendso/bvae071] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/25/2024] [Indexed: 01/06/2025] Open
Abstract
Background Customized and standard automated insulin delivery (AID) systems for use in pregnancies of women with preexisting type 1 diabetes (T1D) are being developed and tested to achieve pregnancy appropriate continuous glucose monitoring (CGM) targets. Guidance on the use of CGM for treatment decisions during pregnancy in the United States is limited. Methods Ten pregnant women with preexisting T1D participated in a trial evaluating at-home use of a pregnancy-specific AID system. Seven-point self-monitoring of blood glucose (SMBG) was compared to the closest sensor glucose (Dexcom G6 CGM) value biweekly to assess safety and reliability based on the 20%/20 mg/dL criteria. Results All participants completed the study with 7 participants satisfying the safety and reliability criteria with a mean absolute relative difference of 10.3%. Three participants did not fulfill the criteria, mainly because the frequency of SMBG did not meet the requirements. Conclusion Dexcom G6 CGM is safe and accurate in the real-world setting for use in pregnant women with preexisting T1D with reduced SMBG testing as part of a pregnancy-specific AID system.
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Affiliation(s)
| | - Carol J Levy
- Department of Endocrine, Diabetes and Bone Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA
| | | | | | | | - Basak Ozaslan
- Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA 02134, USA
| | - Grenye O’Malley
- Department of Endocrine, Diabetes and Bone Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA
| | | | - Camilla Levister
- Department of Endocrine, Diabetes and Bone Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA
| | - Mei Mei Church
- Sansum Diabetes Research Institute, Santa Barbara, CA 93105, USA
| | | | - Selassie Ogyaadu
- Department of Endocrine, Diabetes and Bone Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA
| | | | | | - Francis J Doyle
- Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA 02134, USA
| | - Jordan E Pinsker
- Sansum Diabetes Research Institute, Santa Barbara, CA 93105, USA
| | - Eyal Dassau
- Sansum Diabetes Research Institute, Santa Barbara, CA 93105, USA
- Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA 02134, USA
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Jeeyavudeen MS, Crosby M, Pappachan JM. Continuous glucose monitoring metrics in pregnancy with type 1 diabetes mellitus. World J Methodol 2024; 14:90316. [PMID: 38577196 PMCID: PMC10989406 DOI: 10.5662/wjm.v14.i1.90316] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/29/2023] [Revised: 12/17/2023] [Accepted: 01/16/2024] [Indexed: 03/07/2024] Open
Abstract
Managing diabetes during pregnancy is challenging, given the significant risk it poses for both maternal and foetal health outcomes. While traditional methods involve capillary self-monitoring of blood glucose level monitoring and periodic HbA1c tests, the advent of continuous glucose monitoring (CGM) systems has revolutionized the approach. These devices offer a safe and reliable means of tracking glucose levels in real-time, benefiting both women with diabetes during pregnancy and the healthcare providers. Moreover, CGM systems have shown a low rate of side effects and high feasibility when used in pregnancies complicated by diabetes, especially when paired with continuous subcutaneous insulin infusion pump as hybrid closed loop device. Such a combined approach has been demonstrated to improve overall blood sugar control, lessen the occurrence of preeclampsia and neonatal hypoglycaemia, and minimize the duration of neonatal intensive care unit stays. This paper aims to offer a comprehensive evaluation of CGM metrics specifically tailored for pregnancies impacted by type 1 diabetes mellitus.
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Affiliation(s)
| | - Mairi Crosby
- Department of Endocrinology and Metabolism, University Hospitals of Edinburgh, Edinburgh EH16 4SA, United Kingdom
| | - Joseph M Pappachan
- Department of Endocrinology and Metabolism, Lancashire Teaching Hospitals NHS Trust, Preston PR2 9HT, United Kingdom
- Faculty of Science, Manchester Metropolitan University, Manchester M15 6BH, United Kingdom
- Faculty of Biology, Medicine and Health, The University of Manchester, Manchester M13 9PL, United Kingdom
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Continuous Glucose Monitoring System Profile of Women Stratified Using Different Levels of Glycated Hemoglobin (HbA1c) in Early Pregnancy: A Cross-sectional Study. Adv Ther 2023; 40:951-960. [PMID: 36550320 DOI: 10.1007/s12325-022-02405-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/05/2022] [Accepted: 12/08/2022] [Indexed: 12/24/2022]
Abstract
AIM To evaluate the differences in the continuous glucose monitoring system (CGMS) profiles of women in early pregnancy stratified based on different HbA1c levels known to be predictive of gestational diabetes mellitus (GDM) at 24-28 weeks of gestation (≥ 5.2%) and adverse pregnancy outcomes (≥ 5.5%) in Indian women. METHODS We enrolled women at 8+ 0 to 19+ 6 weeks of gestation (early pregnancy), evaluated the glycaemic parameters of clinical interest using CGMS, and reported them per standard methodology proposed by Hernandez et al. WHO 2013 criteria were used for diagnosis of early GDM. RESULTS Ninety-six women were enrolled at 14.0 ± 3.2 weeks of gestation. Of these, 38 were found to have early GDM (diagnosed before 20 weeks of gestation) on evaluation. Of 96 women, 33 (34.4%) had HbA1c value ≥ 5.5% [11 (19.0%) with normoglycaemia and 22 (57.9%) with GDM]. The women with elevated HbA1c differed significantly from those with HbA1c < 5.5% for all evaluated parameters. The differences for overall women were > 10 mg/dl (0.56 mmol/l) for 1-h postprandial glucose (difference of 0.78 mmol/l), 2-h postprandial glucose (difference of 0.59 mmol/l), peak postprandial glucose (difference of 0.75 mmol/l), and 1-h postprandial glucose excursion (difference of 0.59 mmol/l). Of 58 women with normoglycaemia, 29 (50.0%) had an HbA1c value ≥ 5.2%. In comparison, in the normoglycaemic group of women with and without HbA1c ≥ 5.2% (known to be predictive of future GDM), the results were significant for 1-h (difference of 0.44 mmol/l), 2-h (difference of 0.278 mmol/l), and peak postprandial glucose (difference of 0.35 mmol/l). CONCLUSIONS The results suggest that women with elevated HbA1c (≥ 5.5%) in early pregnancy significantly differ from those with HbA1c < 5.5% in all glycaemic parameters evaluated in this study, suggesting that HbA1c at this cut-off has a role to play in early pregnancy.
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11
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Lemaitre M, Faiz K, Baudoux F, Subtil D, Vambergue A. Intermittently scanned continuous glucose monitoring is associated with lower spontaneous abortion rate compared with conventional blood glucose monitoring in pregnant women with type 1 diabetes: An observational study. Diab Vasc Dis Res 2022; 19:14791641221136837. [PMID: 36515497 PMCID: PMC9756364 DOI: 10.1177/14791641221136837] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022] Open
Abstract
AIM The objective of the present real-life study in France was to assess and compare characteristics and outcomes in a cohort of pregnant women with type 1 diabetes (T1D) using intermittently scanned continuous glucose monitoring (isCGM) or conventional blood glucose monitoring (BGM). MATERIAL AND METHODS We performed an observational study of a cohort of 153 women with T1D: 77 women were using isCGM, and 76 were using BGM. We compared the groups' maternal characteristics and maternal-fetal complications. The level of HbA1c was measured before pregnancy and then four times (after 8-12, 24-28, 30-33, and 35-37 weeks of gestation). RESULTS The two groups were similar in terms of age, prepregnancy BMI, diabetes duration, and diabetic vascular complications. There were no significant intergroup differences in the obstetric history. The spontaneous abortion rate was lower in the isCGM group than in the blood glucose monitoring group (5.3% vs. 20%, respectively; p = .0129), while the prepregnancy and first-trimester HbA1c levels were similar. There were no significant intergroup differences in the incidence of other maternal-fetal complications. CONCLUSIONS This observational study demonstrates that isCGM use is associated with lower spontaneous abortion compared with conventional BGM. Large prospective studies are needed to corroborate our findings and fully understand the relationship between glucose data at the time of conception/early pregnancy and foetal outcome.
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Affiliation(s)
- Madleen Lemaitre
- CHU Lille, Department of Diabetology, Endocrinology, Metabolism and Nutrition, Lille University Hospital, France
- University of Lille, France
- CHU Lille, ULR 2694-METRICS, évaluation des Technologies de Santé et des Pratiques Médicales, University of Lille, France
| | - Kenza Faiz
- CHU Lille, Department of Diabetology, Endocrinology, Metabolism and Nutrition, Lille University Hospital, France
| | - Florence Baudoux
- CHU Lille, Department of Diabetology, Endocrinology, Metabolism and Nutrition, Lille University Hospital, France
| | - Damien Subtil
- University of Lille, France
- CHU Lille, ULR 2694-METRICS, évaluation des Technologies de Santé et des Pratiques Médicales, University of Lille, France
- Department of Gynecology and Obstetrics, CHU Lille, France
| | - Anne Vambergue
- CHU Lille, Department of Diabetology, Endocrinology, Metabolism and Nutrition, Lille University Hospital, France
- University of Lille, France
- European Genomic Institute for Diabetes, France
- Anne Vambergue, Department of Diabetology, Endocrinology, Metabolism and Nutrition, Claude Huriez Hospital, rue Michel Polonovski, F-59037 Lille cedex, France.
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12
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O'Malley G, Wang A, Ogyaadu S, Levy CJ. Assessing Glycemic Control Using CGM for Women with Diabetes in Pregnancy. Curr Diab Rep 2021; 21:44. [PMID: 34735626 DOI: 10.1007/s11892-021-01415-2] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 08/25/2021] [Indexed: 10/19/2022]
Abstract
PURPOSE OF REVIEW Diabetes during pregnancy increases the risk of maternal and fetal complications. This article reviews the types of CGM currently available, the glucose metrics which correlate with pregnancy outcomes, endocrine organization recommendations, clinical considerations for CGM implementation, and anticipated directions for future research. RECENT FINDINGS CGM use during pregnancy is increasing, and recommendations for use have been incorporated into many organizations' consensus guidelines. Increased time spent within a target range of 63-140 mg/dL and lower mean glucose are associated with lower risk of neonatal complications including large for gestational age infants. Use of CGM during pregnancy can detect postprandial and nocturnal hyperglycemia missed by self-monitoring of blood glucose (SMBG) which can be used for prognosis and to guide pharmacologic interventions. The use of continuous glucose monitoring (CGM) during pregnancies complicated by type 1, type 2, and gestational diabetes has been shown to improve outcomes.
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Affiliation(s)
- Grenye O'Malley
- Icahn School of Medicine At Mount Sinai, Division of Endocrinology, Diabetes and Bone Disease, New York, NY, USA.
| | - Ally Wang
- Icahn School of Medicine At Mount Sinai, Division of Endocrinology, Diabetes and Bone Disease, New York, NY, USA
| | - Selassie Ogyaadu
- Icahn School of Medicine At Mount Sinai, Division of Endocrinology, Diabetes and Bone Disease, New York, NY, USA
| | - Carol J Levy
- Icahn School of Medicine At Mount Sinai, Division of Endocrinology, Diabetes and Bone Disease, New York, NY, USA.
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Kaymak O, İskender D, Danışman N. Comparison of one hour versus 90 minute postprandial glucose measurement in women with gestational diabetes; which one is more effective? J OBSTET GYNAECOL 2021; 42:447-451. [PMID: 34159893 DOI: 10.1080/01443615.2021.1920005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/21/2022]
Abstract
In the present study, we aimed to compare postprandial 90 minute measurements and postprandial 1 hour (PP1-HR) measurements for prediction of foetal growth disturbances and pregnancy complications. This was a prospective study conducted in Acıbadem Mehmet Ali Aydınlar University Altunizade Hospital in Department of Perinatology. The study group consisted of patients diagnosed with gestational diabetes. In each antepartum visit, the patients fasting plasma glucose as well as PP1-HR and 90 minute measurements were made. Perinatal and neonatal data were obtained from each patient. The rate of large for gestational age infants was increased in patients when either PP1-HR measurement above 140 mg/dl or postprandial 90 minute measurement above 165 mg/dl compared to patients with normal PP1-HR or postprandial 90 minute measurement. Preterm delivery rate was increased in patients with postprandial 90 minute measurement above 165 mg/dl but not in patients with PP1-HR measurement above 140 mg/dl. The optimal cut-off for postprandial 90 minute measurement was 165 mg/dl based on receiver operating characteristics curve. Our preliminary data show that postprandial 90 minute measurements are superior to PP1-HR measurements in predicting large for gestational age infants.Impact StatementWhat is already known on this subject? Gestational diabetes (GDM) is defined as any degree of glucose intolerance with onset or first recognition in pregnancy. Maternal hyperglycaemia has been linked to metabolic alterations in the foetus and thus brings about foetal macrosomia as well as other pregnancy complications such as preterm delivery and preeclampsia.What the results of this study add? The findings of the present study suggest that postprandial 90 minute predicted more cases of LGA infants than postprandial 1-hour (PP1-HR) measurements. In addition, the rate of preterm deliveries was found to be increased in patients with mean postprandial 90 minute measurements above 165 mg/dl compared to patients with postprandial 90 minute measurements below 165 mg/dl. However, the rate of preterm deliveries was similar in patients with elevated PP1-HR measurements and patients with normal PP1-HR measurements.What the implications are of these findings for clinical practice and/or further research? Our study is the first to investigate the usefulness of postprandial 90 minute in a prospective design. Our preliminary data show that postprandial 90 minute measurements are superior to PP 1 measurements in predicting LGA babies. It also correlates better with preterm deliveries.
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Affiliation(s)
- Oktay Kaymak
- Department of Perinatology, Acıbadem Mehmet Ali Aydınlar University, Istanbul, Turkey
| | - Dicle İskender
- Department of Hematology, Dr. Abdurrahman Yurtaslan Ankara Oncology Research and Training Hospital, Ankara, Turkey
| | - Nuri Danışman
- Department of Perinatology, Acıbadem Mehmet Ali Aydınlar University, Istanbul, Turkey
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Continuous glucose monitoring in obese pregnant women with no hyperglycemia on glucose tolerance test. PLoS One 2021; 16:e0253047. [PMID: 34111215 PMCID: PMC8191902 DOI: 10.1371/journal.pone.0253047] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/16/2020] [Accepted: 05/27/2021] [Indexed: 11/27/2022] Open
Abstract
Objective The objective of the present study was to compare 24-hour glycemic levels between obese pregnant women with normal glucose tolerance and non-obese pregnant women. Methods In the present observational, longitudinal study, continuous glucose monitoring was performed in obese pregnant women with normal oral glucose tolerance test with 75 g of glucose between the 24th and the 28th gestational weeks. The control group (CG) consisted of pregnant women with normal weight who were selected by matching the maternal age and parity with the same characteristics of the obese group (OG). Glucose measurements were obtained during 72 hours. Results Both the groups were balanced in terms of baseline characteristics (age: 33.5 [28.7–36.0] vs. 32.0 [26.0–34.5] years, p = 0.5 and length of pregnancy: 25.0 [24.0–25.0] vs. 25.5 [24.0–28.0] weeks, p = 0.6 in the CG and in the OG, respectively). Pre-breakfast glycemic levels were 77.77 ± 10.55 mg/dL in the CG and 82.02 ± 11.06 mg/dL in the OG (p<0.01). Glycemic levels at 2 hours after breakfast were 87.31 ± 13.10 mg/dL in the CG and 93.48 ± 18.74 mg/dL in the OG (p<0.001). Daytime blood glucose levels were 87.6 ± 15.4 vs. 93.1 ± 18.3 mg/dL (p<0.001) and nighttime blood glucose levels were 79.3 ± 15.8 vs. 84.7 ± 16.3 mg/dL (p<0.001) in the CG and in the OG, respectively. The 24-hour, daytime, and nighttime values of the area under the curve were higher in the OG when compared with the CG (85.1 ± 0.16 vs. 87.9 ± 0.12, 65.6 ± 0.14 vs. 67.5 ± 0.10, 19.5 ± 0.07 vs. 20.4 ± 0.05, respectively; p<0.001). Conclusion The results of the present study showed that obesity in pregnancy was associated with higher glycemic levels even in the presence of normal findings on glucose tolerance test.
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Thomakos P, Kepaptsoglou O, Korantzis A, Trouva A, Sklavounos I, Trouvas D, Taraoune N, Barreto C, Zoupas CS. The diagnosis of Gestational Diabetes Mellitus and its impact on In Vitro Fertilization pregnancies. A pilot study. J Diabetes Complications 2021; 35:107914. [PMID: 33773900 DOI: 10.1016/j.jdiacomp.2021.107914] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/27/2020] [Revised: 03/02/2021] [Accepted: 03/15/2021] [Indexed: 01/05/2023]
Abstract
BACKGROUND In Vitro Fertilization (IVF) is increasingly becoming a necessary mode of reproduction. This high risk group is prone to Gestational Diabetes Mellitus (GDM) which further exposes these pregnancies to an increased risk of adverse outcomes. In light of the limited data in the current literature, further investigation is needed regarding the time of GDM diagnosis in IVF pregnancies as well as the outcome of IVF pregnancies complicated by GDM. METHODS In this three center pilot cross sectional study, the data of 101 singleton IVF pregnancies complicated by GDM were analyzed. Prompt GDM diagnosis in IVF pregnancies was accomplished by self-blood glucose monitoring (SMBG) from the first antenatal visit and confirmed by an OGTT. To evaluate pregnancy outcome, maternal and fetal complications in the 101 GDM IVF group was compared to 101 IVF as well as 101 spontaneous conceptions (SC). The three groups were matched by age. The effect of demographic and glycemic parameters on the outcome of GDM IVF pregnancies was investigated. RESULTS GDM diagnosis was made before the 24th week in 37.6% of the GDM IVF group. The week of delivery was earlier for the GDM IVF group (37 ± 1.7) relative to the IVF (37.9 ± 0.9, p < 0.001) and the SC group (38.1 ± 0.8, p < 0.001). GDM IVF pregnancies exhibited greater preeclampsia rates and 84.8% underwent caesarian section. No significant difference regarding LGA and SGA birth weights was found. Complications of GDM IVF pregnancies were associated with the 1-h postprandial BG (r = 0.267, p = 0.007). CONCLUSION GDM screening in IVF pregnancies may be considered earlier than the 24th week. IVF pregnancies affected by GDM are prone to increased maternal and fetal complications which are associated with 1-h postprandial BG.
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Affiliation(s)
- Petros Thomakos
- Diabetes Center and Clinic, Hygeia General Hospital, 4 Erythrou Stavrou, 151 23 Marousi, Athens, Greece.
| | - Olga Kepaptsoglou
- Diabetes Center and Clinic, Hygeia General Hospital, 4 Erythrou Stavrou, 151 23 Marousi, Athens, Greece.
| | - Asteris Korantzis
- IASO Maternity Hospital, 37-39 Kifisias Avenue, 151 23 Marousi, Athens, Greece.
| | - Anastasia Trouva
- Diabetes Center and Clinic, Hygeia General Hospital, 4 Erythrou Stavrou, 151 23 Marousi, Athens, Greece
| | - Ioannis Sklavounos
- Mitera Maternity Hospital, 6 Erythrou Stavrou, 151 23 Marousi, Athens, Greece
| | - Dimitris Trouvas
- Mitera Maternity Hospital, 6 Erythrou Stavrou, 151 23 Marousi, Athens, Greece.
| | - Nadia Taraoune
- Diabetes Center and Clinic, Hygeia General Hospital, 4 Erythrou Stavrou, 151 23 Marousi, Athens, Greece
| | - Carol Barreto
- Diabetes Center and Clinic, Hygeia General Hospital, 4 Erythrou Stavrou, 151 23 Marousi, Athens, Greece
| | - Christos Sp Zoupas
- Diabetes Center and Clinic, Hygeia General Hospital, 4 Erythrou Stavrou, 151 23 Marousi, Athens, Greece.
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Long-Term IoT-Based Maternal Monitoring: System Design and Evaluation. SENSORS 2021; 21:s21072281. [PMID: 33805217 PMCID: PMC8036648 DOI: 10.3390/s21072281] [Citation(s) in RCA: 20] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 02/06/2021] [Revised: 03/13/2021] [Accepted: 03/20/2021] [Indexed: 12/20/2022]
Abstract
Pregnancy is a unique time when many mothers gain awareness of their lifestyle and its impacts on the fetus. High-quality care during pregnancy is needed to identify possible complications early and ensure the mother’s and her unborn baby’s health and well-being. Different studies have thus far proposed maternal health monitoring systems. However, they are designed for a specific health problem or are limited to questionnaires and short-term data collection methods. Moreover, the requirements and challenges have not been evaluated in long-term studies. Maternal health necessitates a comprehensive framework enabling continuous monitoring of pregnant women. In this paper, we present an Internet-of-Things (IoT)-based system to provide ubiquitous maternal health monitoring during pregnancy and postpartum. The system consists of various data collectors to track the mother’s condition, including stress, sleep, and physical activity. We carried out the full system implementation and conducted a real human subject study on pregnant women in Southwestern Finland. We then evaluated the system’s feasibility, energy efficiency, and data reliability. Our results show that the implemented system is feasible in terms of system usage during nine months. We also indicate the smartwatch, used in our study, has acceptable energy efficiency in long-term monitoring and is able to collect reliable photoplethysmography data. Finally, we discuss the integration of the presented system with the current healthcare system.
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Nichols CR, Cohen AK. Preventing maternal mortality in the United States: lessons from California and policy recommendations. J Public Health Policy 2020; 42:127-144. [PMID: 33268845 DOI: 10.1057/s41271-020-00264-9] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 10/24/2020] [Indexed: 11/21/2022]
Abstract
Maternal mortality remains a large concern in the United States (US), although other Western countries are making progress. In this scoping review, we identify four problems that may contribute to the maternal mortality burden in the US: inadequately investing in women's health, poor quality of care, increasing disparities, and poor data collection and monitoring of maternal health issues. Because maternal mortality is decreasing in California, we identify strategies implemented there that could improve maternal health outcomes nationwide: funding programs to address social determinants of maternal health; supporting health care strategies to improve maternal health (including national standards and goals for health care systems); and investing in maternal health monitoring and surveillance (including use of technology). We encourage researchers, practitioners, and policymakers to work together to develop evidence-based policies and practices to improve maternal health and reduce maternal. We conclude with recommendations for the United States and globally.
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Affiliation(s)
- Chloe R Nichols
- Department of Public and Nonprofit Management, School of Management, University of San Francisco, San Francisco, USA
| | - Alison K Cohen
- Department of Epidemiology & Population Health, School of Medicine, Stanford University, Stanford, USA.
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Castorino K, Polsky S, O'Malley G, Levister C, Nelson K, Farfan C, Brackett S, Puhr S, Levy CJ. Performance of the Dexcom G6 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Diabetes Technol Ther 2020; 22:943-947. [PMID: 32324061 PMCID: PMC7757524 DOI: 10.1089/dia.2020.0085] [Citation(s) in RCA: 35] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
Background: The aim of this study was to determine the performance of the Dexcom G6 continuous glucose monitoring (CGM) system across three sensor wear sites in pregnant women with diabetes in the second or third trimesters. Methods: Participants with type 1 (T1D), type 2 (T2D), or gestational (GDM) diabetes mellitus were enrolled at three sites. Each wore two G6 sensors on the abdomen, upper buttock, and/or posterior upper arm for 10 days and underwent a 6-h clinic session between days 3 and 7 of sensor wear, during which YSI reference blood glucose values were obtained every 30 min. No intentional glucose manipulations were performed. Accuracy metrics included the proportion of CGM values that were within ±20% of paired reference values >100 mg/dL or ±20 mg/dL of YSI values ≤100 mg/dL (hereafter referred to as %20/20), as well as the analogous %15/15, %30/30, and %40/40. The mean absolute relative difference (MARD) between CGM-YSI pairs was also calculated. Results: Thirty-two participants with T1D (n = 20), T2D (n = 3), or GDM (n = 9) were enrolled: 19 were in the second trimester and 13 were in the third trimester of pregnancy. Compared with the reference, 92.5% of CGM values were within ±20%/20 mg/dL. The overall MARD and that of sensors worn on the abdomen, upper buttock, and posterior upper arm was 10.3%, 11.5%, 11.2%, and 8.7%, respectively. There were no device-related adverse events. Skin reactions at the insertion sites were absent or minor. Conclusions: The Dexcom G6 CGM system is accurate and safe in pregnant women with diabetes.
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Affiliation(s)
- Kristin Castorino
- Sansum Diabetes Research Institute, Santa Barbara, California, USA
- Address correspondence to: Kristin Castorino, DO, Sansum Diabetes Research Institute, 2219 Bath Street, Santa Barbara, CA 93105, USA
| | - Sarit Polsky
- Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA
| | - Grenye O'Malley
- Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Camilla Levister
- Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Kristen Nelson
- Sansum Diabetes Research Institute, Santa Barbara, California, USA
| | - Christian Farfan
- Sansum Diabetes Research Institute, Santa Barbara, California, USA
| | - Scott Brackett
- Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA
| | - Sarah Puhr
- Dexcom, Inc., San Diego, California, USA
| | - Carol J. Levy
- Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA
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Huhn EA, Linder T, Eppel D, Weißhaupt K, Klapp C, Schellong K, Henrich W, Yerlikaya-Schatten G, Rosicky I, Husslein P, Chalubinski K, Mittlböck M, Rust P, Hoesli I, Winzeler B, Jendle J, Fehm T, Icks A, Vomhof M, Greiner GG, Szendrödi J, Roden M, Tura A, Göbl CS. Effectiveness of real-time continuous glucose monitoring to improve glycaemic control and pregnancy outcome in patients with gestational diabetes mellitus: a study protocol for a randomised controlled trial. BMJ Open 2020; 10:e040498. [PMID: 33257486 PMCID: PMC7705524 DOI: 10.1136/bmjopen-2020-040498] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/21/2023] Open
Abstract
INTRODUCTION Real-time continuous glucose monitoring (rt-CGM) informs users about current interstitial glucose levels and allows early detection of glycaemic excursions and timely adaptation by behavioural change or pharmacological intervention. Randomised controlled studies adequately powered to evaluate the impact of long-term application of rt-CGM systems on the reduction of adverse obstetric outcomes in women with gestational diabetes (GDM) are missing. We aim to assess differences in the proportion of large for gestational age newborns in women using rt-CGM as compared with women with self-monitored blood glucose (primary outcome). Rates of neonatal hypoglycaemia, caesarean section and shoulder dystocia are secondary outcomes. A comparison of glucose metabolism and quality of life during and after pregnancy completes the scope of this study. METHODS AND ANALYSIS Open-label multicentre randomised controlled trial with two parallel groups including 372 female patients with a recent diagnosis of GDM (between 24+0 until 31+6 weeks of gestation): 186 with rt-CGM (Dexcom G6) and 186 with self-monitored blood glucose (SMBG). Women with GDM will be consecutively recruited and randomised to rt-CGM or control (SMBG) group after a run-in period of 6-8 days. The third visit will be scheduled 8-10 days later and then every 2 weeks. At every visit, glucose measurements will be evaluated and all patients will be treated according to the standard care. The control group will receive a blinded CGM for 10 days between the second and third visit and between week 36+0 and 38+6. Cord blood will be sampled immediately after delivery. 48 hours after delivery neonatal biometry and maternal glycosylated haemoglobin A1c (HbA1c) will be assessed, and between weeks 8 and 16 after delivery all patients receive a re-examination of glucose metabolism including blinded CGM for 8-10 days. ETHICS AND DISSEMINATION This study received ethical approval from the main ethic committee in Vienna. Data will be presented at international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT03981328; Pre-results.
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Affiliation(s)
- Evelyn Annegret Huhn
- Department of Obstetrics and Gynaecology, University Hospital Basel, Basel, Switzerland
| | - Tina Linder
- Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria
| | - Daniel Eppel
- Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria
| | - Karen Weißhaupt
- Clinic of Obstetrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
| | - Christine Klapp
- Clinic of Obstetrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
| | - Karen Schellong
- Clinic of Obstetrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
| | - Wolfgang Henrich
- Clinic of Obstetrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
| | - Gülen Yerlikaya-Schatten
- Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria
| | - Ingo Rosicky
- Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria
| | - Peter Husslein
- Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria
| | - Kinga Chalubinski
- Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria
| | - Martina Mittlböck
- Center of Medical Statistics, Informatics, and Intelligent Systems, Section for Clinical Biometrics, Medical University of Vienna, Vienna, Austria
| | - Petra Rust
- Department of Nutritional Sciences, University of Vienna, Vienna, Austria
| | - Irene Hoesli
- Department of Obstetrics and Gynaecology, University Hospital Basel, Basel, Switzerland
| | - Bettina Winzeler
- Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland
| | - Johan Jendle
- Institution of Medical Sciences, Örebro University, Örebro, Sweden
| | - T Fehm
- Department of Obstetrics and Gynaecology, Medical Faculty, Heinrich-Heine University Düsseldorf, Dusseldorf, Germany
| | - Andrea Icks
- Institute of Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich Heine University, Düsseldorf, Germany
- Institute for Health Services Research and Health Economics, German Diabetes Center at Heinrich-Heine University Düsseldorf, Leibniz Institute for Diabetes Research, Düsseldorf, Germany
- German Center for Diabetes Research, München-Neuherberg, Oberschleißheim, Germany
| | - Markus Vomhof
- Institute of Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich Heine University, Düsseldorf, Germany
- Institute for Health Services Research and Health Economics, German Diabetes Center at Heinrich-Heine University Düsseldorf, Leibniz Institute for Diabetes Research, Düsseldorf, Germany
- German Center for Diabetes Research, München-Neuherberg, Oberschleißheim, Germany
| | - Gregory Gordon Greiner
- Institute of Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich Heine University, Düsseldorf, Germany
- Institute for Health Services Research and Health Economics, German Diabetes Center at Heinrich-Heine University Düsseldorf, Leibniz Institute for Diabetes Research, Düsseldorf, Germany
- German Center for Diabetes Research, München-Neuherberg, Oberschleißheim, Germany
| | - Julia Szendrödi
- German Center for Diabetes Research, München-Neuherberg, Oberschleißheim, Germany
- Division of Endocrinology and Diabetology, Medical Faculty, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany
- Institute for Clinical Diabetology, German Diabetes Centre, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany
| | - Michael Roden
- German Center for Diabetes Research, München-Neuherberg, Oberschleißheim, Germany
- Division of Endocrinology and Diabetology, Medical Faculty, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany
- Institute for Clinical Diabetology, German Diabetes Centre, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany
| | - Andrea Tura
- Metabolic Unit, Institute of Neuroscience, National Research Council, Padova, Italy
| | - Christian S Göbl
- Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria
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Galindo RJ, Umpierrez GE, Rushakoff RJ, Basu A, Lohnes S, Nichols JH, Spanakis EK, Espinoza J, Palermo NE, Awadjie DG, Bak L, Buckingham B, Cook CB, Freckmann G, Heinemann L, Hovorka R, Mathioudakis N, Newman T, O’Neal DN, Rickert M, Sacks DB, Seley JJ, Wallia A, Shang T, Zhang JY, Han J, Klonoff DC. Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline. J Diabetes Sci Technol 2020; 14:1035-1064. [PMID: 32985262 PMCID: PMC7645140 DOI: 10.1177/1932296820954163] [Citation(s) in RCA: 85] [Impact Index Per Article: 17.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
This article is the work product of the Continuous Glucose Monitor and Automated Insulin Dosing Systems in the Hospital Consensus Guideline Panel, which was organized by Diabetes Technology Society and met virtually on April 23, 2020. The guideline panel consisted of 24 international experts in the use of continuous glucose monitors (CGMs) and automated insulin dosing (AID) systems representing adult endocrinology, pediatric endocrinology, obstetrics and gynecology, advanced practice nursing, diabetes care and education, clinical chemistry, bioengineering, and product liability law. The panelists reviewed the medical literature pertaining to five topics: (1) continuation of home CGMs after hospitalization, (2) initiation of CGMs in the hospital, (3) continuation of AID systems in the hospital, (4) logistics and hands-on care of hospitalized patients using CGMs and AID systems, and (5) data management of CGMs and AID systems in the hospital. The panelists then developed three types of recommendations for each topic, including clinical practice (to use the technology optimally), research (to improve the safety and effectiveness of the technology), and hospital policies (to build an environment for facilitating use of these devices) for each of the five topics. The panelists voted on 78 proposed recommendations. Based on the panel vote, 77 recommendations were classified as either strong or mild. One recommendation failed to reach consensus. Additional research is needed on CGMs and AID systems in the hospital setting regarding device accuracy, practices for deployment, data management, and achievable outcomes. This guideline is intended to support these technologies for the management of hospitalized patients with diabetes.
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Affiliation(s)
| | | | | | - Ananda Basu
- University of Virginia School of Medicine, Charlottesville, VA, USA
| | - Suzanne Lohnes
- University of California San Diego Medical Center, La Jolla, CA, USA
| | | | - Elias K. Spanakis
- University of Maryland School of Medicine, Baltimore, MD, USA
- Division of Endocrinology, Baltimore Veterans Affairs Medical Center, MD, USA
| | | | - Nadine E. Palermo
- Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
| | | | | | | | | | | | | | | | | | - Tonya Newman
- Neal, Gerber and Eisenberg LLP, Chicago, IL, USA
| | - David N. O’Neal
- University of Melbourne Department of Medicine, St. Vincent’s Hospital, Fitzroy, Victoria, Australia
| | | | | | | | - Amisha Wallia
- Northwestern University Feinberg School of Medicine, Chicago, IL, USA
| | - Trisha Shang
- Diabetes Technology Society, Burlingame, CA, USA
| | | | - Julia Han
- Diabetes Technology Society, Burlingame, CA, USA
| | - David C. Klonoff
- Mills-Peninsula Medical Center, San Mateo, CA, USA
- David C. Klonoff, MD, FACP, FRCP (Edin), Fellow AIMBE, Mills-Peninsula Medical Center, 100 South San Mateo Drive Room 5147, San Mateo, CA 94401, USA.
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Nosova EV, O'Malley G, Dassau E, Levy CJ. Leveraging technology for the treatment of type 1 diabetes in pregnancy: A review of past, current, and future therapeutic tools. J Diabetes 2020; 12:714-732. [PMID: 32125763 DOI: 10.1111/1753-0407.13030] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/27/2020] [Accepted: 03/01/2020] [Indexed: 12/16/2022] Open
Abstract
The significant risks associated with pregnancies complicated by type 1 diabetes (T1D) were first recognized in the medical literature in the mid-twentieth century. Stringent glycemic control with hemoglobin A1c (HbA1c) values ideally less than 6% has been shown to improve maternal and fetal outcomes. The management options for pregnant women with T1D in the modern era include a variety of technologies to support self-care. Although self-monitoring of blood glucose (SMBG) and multiple daily injections (MDI) are often the recommended management options during pregnancy, many people with T1D utilize a variety of different technologies, including continuous glucose monitoring (CGM), continuous subcutaneous insulin infusion (CSII), and CSII including automated delivery or suspension algorithms. These systems have yielded invaluable diagnostic and therapeutic capabilities and have the potential to benefit this understudied higher-risk group. A recent prospective, multicenter study evaluating pregnant patients with T1D revealed that CGM significantly improves maternal glycemic parameters, is associated with fewer adverse neonatal outcomes, and minimizes burden. Outcome data for CSII, which is approved for use in pregnancy and has been utilized for several decades, remain mixed. Current evidence, although limited, for commercially available and emerging technologies for the management of T1D in pregnancy holds promise for improving patient and fetal outcomes.
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Affiliation(s)
- Emily V Nosova
- Division of Endocrinology, Diabetes and Bone Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Grenye O'Malley
- Division of Endocrinology, Diabetes and Bone Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Eyal Dassau
- Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, Massachusetts, USA
| | - Carol J Levy
- Division of Endocrinology, Diabetes and Bone Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA
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Polsky S, Garcetti R, Pyle L, Joshee P, Demmitt JK, Snell-Bergeon JK. Continuous glucose monitor use with and without remote monitoring in pregnant women with type 1 diabetes: A pilot study. PLoS One 2020; 15:e0230476. [PMID: 32298269 PMCID: PMC7162510 DOI: 10.1371/journal.pone.0230476] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/29/2019] [Accepted: 03/01/2020] [Indexed: 02/02/2023] Open
Abstract
BACKGROUND To examine whether continuous glucose monitoring (CGM) with remote monitoring by followers (family/friends) changes glucose management, follower interventions, and health outcomes compared to CGM alone in pregnant women with diabetes. METHODS We prospectively stratified first trimester pregnant women with Type 1 Diabetes to CGM Share (remote monitoring) or CGM Alone. We enrolled a main follower per woman. We retrospectively acquired data for pregnant women who did not use CGM (no CGM). We compared hemoglobin A1c (HbA1c) between groups. We compared sensor glucose, follower interventions, and gestational outcomes between CGM Alone and CGM Share. Longitudinal mixed effects models were used for analyses of changes in outcomes over time. RESULTS HbA1c decreased in all groups throughout pregnancy and was significantly lower over time in women using CGM Share (n = 15) compared to CGM Alone (n = 13) or no CGM (n = 8) (p = 0.0042). CGM Share users had lower median sensor glucose levels (p = 0.0331) and percent time spent >180 mg/dL (p = 0.0228) across pregnancy. There were no significant differences in maternal and fetal outcomes between groups. CGM Share followers had more alerts for hypoglycemia, but did fewer interventions. CONCLUSIONS In this small pilot study, use of CGM with remote monitoring improved some glycemic metrics in pregnant women with diabetes.
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Affiliation(s)
- Sarit Polsky
- Barbara Davis Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States of America
- * E-mail:
| | - Rachel Garcetti
- Barbara Davis Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States of America
| | - Laura Pyle
- Department of Pediatrics, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States of America
| | - Prakriti Joshee
- Barbara Davis Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States of America
| | - Jamie K. Demmitt
- Barbara Davis Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States of America
| | - Janet K. Snell-Bergeon
- Barbara Davis Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States of America
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Márquez-Pardo R, Torres-Barea I, Córdoba-Doña JA, Cruzado-Begines C, García-García-Doncel L, Aguilar-Diosdado M, Baena-Nieto MG. Continuous Glucose Monitoring and Glycemic Patterns in Pregnant Women with Gestational Diabetes Mellitus. Diabetes Technol Ther 2020; 22:271-277. [PMID: 31638416 DOI: 10.1089/dia.2019.0319] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/25/2022]
Abstract
Background: Continuous glucose monitoring (CGM) could detect certain patterns of hyperglycemia at different times of the day that may help predict the development of maternal-fetal complications and the probability of needing pharmacological treatment. Methods: This study prospectively examined 77 women with gestational diabetes mellitus (GDM) who were placed on a CGM system for 6 days after diagnosis between 26 and 32 weeks of gestation. Patterns of hyperglycemia before meals (period of time of an hour just before meal) (>95 mg/dL), after meals (time interval of 2 h and half just after meal) (>140 mg/dL), and overnight (0-7 am) (>120 mg/dL) and their association with maternal-fetal complications and pharmacological treatment were analyzed. Receiver operating characteristic curves were developed to estimate the validity of the various patterns in detecting the need for pharmacological treatment. Results: A statistically significant relationship was observed between time in hyperglycemia after lunch and macrosomia (P = 0.035) and large for gestational age infants (P = 0.010). Pharmacological treatment was required for patients with time above range (TAR; P = 0.006) and those with hyperglycemia patterns before breakfast (P < 0.001), after breakfast (P = 0.006), before dinner (P = 0.012), and overnight (P = 0.001). Every additional percentage point of TAR was associated with a 24% increase in the probability of pharmacological treatment. Conclusions: The use of CGM for the diagnosis of GDM allows the identification of those patients who would benefit from closer monitoring during pregnancy, including self-monitoring of both pre- and postprandial blood glucose levels, facilitating the initiation of early pharmacological treatment.
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Affiliation(s)
- Rosa Márquez-Pardo
- Department of Endocrinology and Nutrition and Jerez Hospital, Jerez de la Frontera, Spain
- Biomedical Research and Innovation Institute of Cádiz (INIBiCA) Research Unit, Puerta del Mar University Hospital, University of Cádiz, Spain
| | - Isabel Torres-Barea
- Biomedical Research and Innovation Institute of Cádiz (INIBiCA) Research Unit, Puerta del Mar University Hospital, University of Cádiz, Spain
- Department of Endocrinology and Nutrition, Puerta del Mar Hospital, Cádiz, Spain
| | - Juan-Antonio Córdoba-Doña
- Biomedical Research and Innovation Institute of Cádiz (INIBiCA) Research Unit, Puerta del Mar University Hospital, University of Cádiz, Spain
- Department of Preventive Medicine and Public Health, Jerez Hospital, Jerez de la Frontera, Spain
| | | | - Lourdes García-García-Doncel
- Department of Endocrinology and Nutrition and Jerez Hospital, Jerez de la Frontera, Spain
- Biomedical Research and Innovation Institute of Cádiz (INIBiCA) Research Unit, Puerta del Mar University Hospital, University of Cádiz, Spain
| | - Manuel Aguilar-Diosdado
- Biomedical Research and Innovation Institute of Cádiz (INIBiCA) Research Unit, Puerta del Mar University Hospital, University of Cádiz, Spain
- Department of Endocrinology and Nutrition, Puerta del Mar Hospital, Cádiz, Spain
| | - María-Gloria Baena-Nieto
- Department of Endocrinology and Nutrition and Jerez Hospital, Jerez de la Frontera, Spain
- Biomedical Research and Innovation Institute of Cádiz (INIBiCA) Research Unit, Puerta del Mar University Hospital, University of Cádiz, Spain
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Jotic A, Milicic T, Lalic K, Lukic L, Macesic M, Stanarcic Gajovic J, Stoiljkovic M, Gojnic Dugalic M, Jeremic V, Lalic NM. Evaluation of Glycaemic Control, Glucose Variability and Hypoglycaemia on Long-Term Continuous Subcutaneous Infusion vs. Multiple Daily Injections: Observational Study in Pregnancies With Pre-Existing Type 1 Diabetes. Diabetes Ther 2020; 11:845-858. [PMID: 32060738 PMCID: PMC7136374 DOI: 10.1007/s13300-020-00780-7] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/29/2019] [Indexed: 12/20/2022] Open
Abstract
INTRODUCTION We evaluated the effectiveness of long-term continuous subcutaneous insulin infusion (CSII) compared with multiple daily insulin (MDI) injections for glycaemic control and variability, hypoglycaemic episodes and maternal/neonatal outcomes in pregnant women with pre-existing type 1 diabetes (pT1D). METHODS Our observational cohort study included 128 consecutive pregnant women with pT1D, who were treated from 1 January 2010 to 31 December 2017. Of 128 participants, 48 were on CSII and 80 were on MDI. Glycaemic control was determined by glycated haemoglobin (HbA1c) (captured in preconception and each trimester of pregnancy). Glucose variability (GV) was expressed as the coefficient of variation (CV) [calculated from self-monitoring of blood glucose (SMBG) values], and hypoglycaemia was defined as glucose values < 3.9 mmol/l. The data on maternal and neonatal outcomes were collected from obstetrical records. RESULTS Duration of the treatment was 8.8 ± 5.3 years in the CSII and 12.6 ± 8.0 years in the MDI group. The CSII lowered HbA1c in preconception (7.1 ± 0.1 vs. 7.9 ± 0.2%, p = 0.03) and the first (6.9 ± 0.1 vs. 7.7 ± 0.2%, p = 0.02), second (6.6 ± 0.1 vs. 7.2 ± 0.1%, p = 0.003) and third (6.5 ± 0.1 vs. 6.8 ± 0.1%, p = 0.02) trimesters significantly better than MDI. Significantly lower CV was observed only for fasting glycaemia in the first trimester (17.1 vs 28.4%, p < 0.001) in favour of CSII. Moreover, the CSII group had significantly lower mean hypoglycaemic episodes/week/patient only during the first trimester (2.0 ± 1.7 vs 4.8 ± 1.5, p < 0.01). In early pregnancy, the majority of women on CSII had less hypoglycaemia than on MDI (0-3: 79.1 vs. 29.1%; 4-6: 18.8 vs. 65.8%; ≥ 7: 2.1 vs. 5.1%, p < 0.01, respectively). We found no difference in the incidence of adverse maternal/neonatal outcomes. CONCLUSIONS Treatment with CSII resulted in a favourable reduction of HbA1c in the preconception period and each trimester in pregnancy. Moreover, long-term CSII treatment demonstrated more stable metabolic control with less GV of fasting glycaemia and fewer hypoglyacemic episodes only during early pregnancy.
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Affiliation(s)
- Aleksandra Jotic
- Clinic for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia, Dr. Subotića 13, 11000, Belgrade, Serbia.
- Faculty of Medicine, University of Belgrade, Dr. Subotića 8, 11000, Belgrade, Serbia.
| | - Tanja Milicic
- Clinic for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia, Dr. Subotića 13, 11000, Belgrade, Serbia
- Faculty of Medicine, University of Belgrade, Dr. Subotića 8, 11000, Belgrade, Serbia
| | - Katarina Lalic
- Clinic for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia, Dr. Subotića 13, 11000, Belgrade, Serbia
- Faculty of Medicine, University of Belgrade, Dr. Subotića 8, 11000, Belgrade, Serbia
| | - Ljiljana Lukic
- Clinic for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia, Dr. Subotića 13, 11000, Belgrade, Serbia
- Faculty of Medicine, University of Belgrade, Dr. Subotića 8, 11000, Belgrade, Serbia
| | - Marija Macesic
- Clinic for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia, Dr. Subotića 13, 11000, Belgrade, Serbia
- Faculty of Medicine, University of Belgrade, Dr. Subotića 8, 11000, Belgrade, Serbia
| | - Jelena Stanarcic Gajovic
- Clinic for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia, Dr. Subotića 13, 11000, Belgrade, Serbia
| | - Milica Stoiljkovic
- Clinic for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia, Dr. Subotića 13, 11000, Belgrade, Serbia
| | - Miroslava Gojnic Dugalic
- Faculty of Medicine, University of Belgrade, Dr. Subotića 8, 11000, Belgrade, Serbia
- Clinic for Gynecology and Obstetrics, Clinical Center of Serbia, Visegradska 26, 11000, Belgrade, Serbia
| | - Veljko Jeremic
- Department for Operations Research and Statistics, Faculty of Organizational Sciences, University of Belgrade, Belgrade, Serbia
| | - Nebojsa M Lalic
- Clinic for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia, Dr. Subotića 13, 11000, Belgrade, Serbia
- Faculty of Medicine, University of Belgrade, Dr. Subotića 8, 11000, Belgrade, Serbia
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Arnaert A, Ponzoni N, Debe Z, Meda MM, Nana NG, Arnaert S. Experiences of women receiving mhealth-supported antenatal care in the village from community health workers in rural Burkina Faso, Africa. Digit Health 2019; 5:2055207619892756. [PMID: 31832224 PMCID: PMC6891107 DOI: 10.1177/2055207619892756] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/30/2019] [Accepted: 11/11/2019] [Indexed: 12/17/2022] Open
Abstract
Objective This qualitative study explored the experiences of women receiving
mhealth-supported antenatal care in a village, from community health workers
(CHWs) in rural Burkina Faso, Africa. Intervention CHWs entered patient clinical data manually in their smartphone during their
home visits. All wireless transferred data was monitored by the midwives in
the community clinic for arising medical complications. Methods Semi-structured interviews were conducted with 19 pregnant women, who were
housewives, married and their age ranged from 18 to 39 years. None had
completed their formal education. Depending on the weeks of gestation during
their first antenatal care visit, length of enrollment in the project varied
between three and eight months. Transcripts were content-analyzed. Results Despite the fact that mhealth was a novel service for all participants, they
expressed appreciation for these interventions, which they found beneficial
on three levels: 1) it allowed for early detection of pregnancy-related
complications, 2) it was perceived as promoting collaboration between CHWs
and midwives, and 3) it was a source of reassurance during a time when they
are concerned about their health. Although not unanimous, certain
participants said their husbands were more interested in their antenatal
care as a result of these services. Conclusion Findings suggested that mhealth-supported visits of the CHWs have the
potential to increase mothers’ knowledge about their pregnancy and, as such,
motivate them to attend more ANC visits. In response to this increased
patient engagement, midwives approached women differently, which led to the
mothers’ perception of improvement in the patient–provider relationship.
Results also indicated that mhealth may increase spousal involvement, as
services are offered at home, which is an environment where spouses feel
more comfortable.
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Affiliation(s)
- Antonia Arnaert
- Ingram School of Nursing, McGill University, Montreal, Canada
| | - Norma Ponzoni
- Ingram School of Nursing, McGill University, Montreal, Canada
| | - Zoumanan Debe
- Ingram School of Nursing, McGill University, Montreal, Canada
| | - Mouoboum M Meda
- Institut de Formation et de Recherche Interdisciplinaire en Santé (IFRIS), Burkina Faso
| | - Noufou G Nana
- Institut de Formation et de Recherche Interdisciplinaire en Santé (IFRIS), Burkina Faso
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Nigam A, Sharma S, Varun N, Munjal YP, Prakash A. Comparative analysis of 2‐week glycaemic profile of healthy versus mild gestational diabetic pregnant women using flash glucose monitoring system: an observational study. BJOG 2019; 126 Suppl 4:27-33. [DOI: 10.1111/1471-0528.15849] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 06/17/2019] [Indexed: 12/16/2022]
Affiliation(s)
- A Nigam
- Department of Obstetrics and Gynaecology Hamdard Institute of Medical Sciences and Research New Delhi India
| | - S Sharma
- Department of Obstetrics and Gynaecology Hamdard Institute of Medical Sciences and Research New Delhi India
| | - N Varun
- Department of Obstetrics and Gynaecology Hamdard Institute of Medical Sciences and Research New Delhi India
| | - YP Munjal
- Physician Research Foundation Artemis Hospital Gurugram Gurugram India
| | - A Prakash
- Department of Medicine Lady Hardinge Medical College & Associated SSK Hospital New Delhi India
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Guo H, Zhang Y, Li P, Zhou P, Chen LM, Li SY. Evaluating the effects of mobile health intervention on weight management, glycemic control and pregnancy outcomes in patients with gestational diabetes mellitus. J Endocrinol Invest 2019; 42:709-714. [PMID: 30406378 DOI: 10.1007/s40618-018-0975-0] [Citation(s) in RCA: 64] [Impact Index Per Article: 10.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/25/2018] [Accepted: 10/31/2018] [Indexed: 12/22/2022]
Abstract
PURPOSE To explore the effects of mobile health (mHealth) intervention on pregnancy weight management, blood glucose control and pregnancy outcomes. METHODS A total of 124 patients with gestational diabetes mellitus (GDM) were selected. Patients were randomly divided into two groups. The 60 patients in the control group received standard outpatient treatment, while the remaining 64 patients received a nurse's online guidance both through a mobile medical App installed on their phone and through regular offline clinical treatment in the mHealth group. Patients were treated for an average of 13 weeks and general conditions, compliance, blood glucose, glycosylated hemoglobin, weight gain, pregnancy, and neonatal outcomes were monitored in both groups longitudinally. RESULTS The mHealth group demonstrated higher levels of compliance (83.3 ± 12.5% vs. 70.4 ± 10.1%, t = - 6.293, df = 122, p < 0.001), lower frequency of outpatient service (8.1 ± 1.3 vs. 11.2 ± 1.1, t = 14.285, df = 122, p < 0.001), lower hemoglobin A1C before delivery (4.7 ± 0.2 vs. 5.3 ± 0.3, t = 13.216, df = 122, p < 0.001) as well as the rates of off-target measurements both fasting (4.6 ± 0.4% vs. 8.3 ± 0.6%, t = 40.659, df = 122, p < 0.001) and 2 h post-prandial (7.9 ± 0.7% vs. 14.7 ± 0.8%, t = 50.746, df = 122, p < 0.001). Weight gain in the mHealth group was less than control group (3.2 ± 0.8 vs. 4.8 ± 0.7, t = 11.851, df = 122 p < 0.001). CONCLUSION Mobile health intervention management of gestational diabetes mellitus improves patients' compliance and blood glucose control, and reduces weight gain, thereby reducing the rates of complications in both pregnant women and fetuses during delivery during pregnancy.
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Affiliation(s)
- H Guo
- NHC Key Laboratory of Hormones and Development (Tianjin Medical University), Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Metabolic Diseases Hospital, Tianjin Institute of Endocrinology, Tianjin, 300070, China
| | - Y Zhang
- NHC Key Laboratory of Hormones and Development (Tianjin Medical University), Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Metabolic Diseases Hospital, Tianjin Institute of Endocrinology, Tianjin, 300070, China
| | - P Li
- NHC Key Laboratory of Hormones and Development (Tianjin Medical University), Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Metabolic Diseases Hospital, Tianjin Institute of Endocrinology, Tianjin, 300070, China
| | - P Zhou
- NHC Key Laboratory of Hormones and Development (Tianjin Medical University), Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Metabolic Diseases Hospital, Tianjin Institute of Endocrinology, Tianjin, 300070, China
| | - L-M Chen
- NHC Key Laboratory of Hormones and Development (Tianjin Medical University), Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Metabolic Diseases Hospital, Tianjin Institute of Endocrinology, Tianjin, 300070, China
| | - S-Y Li
- NHC Key Laboratory of Hormones and Development (Tianjin Medical University), Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Metabolic Diseases Hospital, Tianjin Institute of Endocrinology, Tianjin, 300070, China.
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Nigam A, Varun N, Sharma S, Munjal YP, Prakash A. Glycaemic profile in the second and third trimesters of normal pregnancy compared to non-pregnant adult females. Obstet Med 2019; 13:30-36. [PMID: 32284730 DOI: 10.1177/1753495x18807549] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/23/2018] [Accepted: 09/25/2018] [Indexed: 11/17/2022] Open
Abstract
Aim To assess the glycaemic profile and glycaemic variation in the second and third trimesters of normal pregnancies. Methodology Healthy pregnant women aged 19-35 years between 24 and 36 weeks of gestation were recruited for ambulatory glucose profile monitoring. A total of 18 women in the second trimester, 15 women in the third trimester and 9 healthy non-pregnant women were recruited providing, respectively, 205 days (19,680 data points), 147 days (14,112 data points) and 100 days (9,600 data points) for analysis. Results Mean blood glucose level was 20.2% lower in the second trimester and 10.6% lower in the third trimester than non-pregnant women (p < 0.001). In pregnancy, it took 15 to 20 minutes more to reach peak postprandial blood glucose levels compared to non-pregnant women (p = 0.003). Glycaemic variability was more in the third trimester (p < 0.001). Conclusion There is tight blood sugar control along with lower mean blood glucose in healthy pregnant women compared to non-pregnant women. Despite this tight glycaemic control, glycaemic variability is higher during pregnancy.
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Affiliation(s)
- Aruna Nigam
- Department of Obstetrics and Gynaecology, Hamdard Institute of Medical Sciences and Research, Jamia Hamdard, New Delhi, India
| | - Neha Varun
- Department of Obstetrics and Gynaecology, Hamdard Institute of Medical Sciences and Research, Jamia Hamdard, New Delhi, India
| | - Sumedha Sharma
- Department of Obstetrics and Gynaecology, Hamdard Institute of Medical Sciences and Research, Jamia Hamdard, New Delhi, India
| | - Y P Munjal
- Diabetes Centre, Banarsidas Chandiwala Institute of Medical Sciences, New Delhi, India
| | - Anupam Prakash
- Department of Medicine, Lady Hardinge Medical College and Associated SSK Hospital, New Delhi, India
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Schiel R, Bambauer R, Steveling A. Technology in Diabetes Treatment: Update and Future. Artif Organs 2018; 42:1017-1027. [PMID: 30334582 DOI: 10.1111/aor.13296] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/28/2018] [Revised: 04/20/2018] [Accepted: 05/24/2018] [Indexed: 12/14/2022]
Abstract
Worldwide the number of people with diabetes mellitus is increasing. There are estimations that diabetes is one of the leading causes of death. The most important goals for the treatment of diabetes are self-management of the disease and an optimal quality of diabetes control. In the therapy new technologies, like real-time continuous interstitial glucose monitoring, continuous subcutaneous insulin infusion (CSII), electronic tools for the monitoring of therapeutic approaches, automated bolus calculators for insulin and electronic tools for education and information of patients, have become widespread and play important roles. All these efforts are related to the interaction between patients, caregivers, scientists or researchers and industry. The presentation of different aspects of new technological approaches in the present article should give more information about different technologies. However, because of the rather quickly appearance of new technologies, the presentation can only be a spotlight. Further studies are mandatory to analyze the effects and long-term benefits of each technology and electronic device.
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Affiliation(s)
- Ralf Schiel
- MEDIGREIF-Inselklinik Heringsdorf GmbH, Fachklinik für Kinder und Jugendliche, Ostseebad Heringsdorf, Germany
| | - Rolf Bambauer
- Formely Institute for Blood Purification, Homburg, Germany
| | - Antje Steveling
- Ernst-Moritz-Arndt-University, Internal Medicine A, Greifswald, Germany
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30
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Feig DS, Murphy HR. Continuous glucose monitoring in pregnant women with Type 1 diabetes: benefits for mothers, using pumps or pens, and their babies. Diabet Med 2018; 35:430-435. [PMID: 29352491 DOI: 10.1111/dme.13585] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 01/15/2018] [Indexed: 12/16/2022]
Abstract
AIMS To review the current literature on the use of continuous glucose monitoring during pregnancy in women with Type 1 diabetes. METHODS We searched the literature for randomized controlled trials using continuous glucose monitoring during pregnancy in women with Type 1 diabetes. RESULTS Three randomized trials were found and discussed in this review. One UK study found a reduction in large-for-gestational-age infants; however, only masked continuous glucose monitoring was used in that study. A Danish study used intermittent real-time continuous glucose monitoring and found no differences. The present authors conducted the CONCEPTT trial, in which pregnant women and women planning pregnancy were randomized to receive continuous glucose monitoring or standard care. We found a greater drop in HbA1c , more time spent in the target range, and a reduction in some adverse neonatal outcomes in women using continuous glucose monitoring. Numbers-needed-to-treat to prevent a large-for-gestational-age infant, a neonatal intensive care unit admission for >24 h, and a neonatal hypoglycaemia event were low. These findings were seen in both injection and pump users and across all countries. Possible reasons for differences in study findings are discussed. In addition, several issues need further study. Glycaemic variability and differences in dietary intake may also have played a role. Despite excellent glycaemic control, babies continue to be large. More research is needed to understand the role of glucose targets and the dynamic placental processes involved in fetal growth. CONCLUSIONS The use of continuous glucose monitoring in women with Type 1 diabetes in pregnancy is associated with improved glycaemic control and neonatal outcomes. Further research examining the glycaemic and non-glycaemic variables involved in fetal growth and the cost-benefit of using continuous glucose monitoring in pregnancy is warranted.
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Affiliation(s)
- D S Feig
- Sinai Health System, Toronto, Canada
- Lunenfeld-Tanenbaum Research Institute, Toronto, Canada
- Department of Medicine, University of Toronto, Toronto, Canada
| | - H R Murphy
- Cambridge University Hospitals NHS Foundation Trust, Cambridge
- Department of Women and Children's Health, King's College London, London
- Department of Medicine, University of East Anglia, Norwich, UK
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Affiliation(s)
- Sarit Polsky
- Barbara Davis Center for Diabetes, University of Colorado Denver, Aurora, Colorado
- Address correspondence to:SaritPolsky, MD, MPHBarbara Davis Center for DiabetesUniversity of Colorado Denver1775 Aurora Court, MS A140Aurora, CO 80045
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Garg SK, Polsky S. Continuous glucose monitoring in pregnant women with type 1 diabetes. Lancet 2017; 390:2329-2331. [PMID: 28923466 DOI: 10.1016/s0140-6736(17)32449-2] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/17/2017] [Accepted: 08/25/2017] [Indexed: 12/14/2022]
Affiliation(s)
- Satish K Garg
- The Barbara Davis Center for Diabetes, University of Colorado Denver, Aurora, CO 80045, USA.
| | - Sarit Polsky
- The Barbara Davis Center for Diabetes, University of Colorado Denver, Aurora, CO 80045, USA
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Affiliation(s)
- Satish K. Garg
- School of Medicine, University of Colorado Denver, Aurora, Colorado
- Barbara Davis Center for Diabetes, Aurora, Colorado
| | - Halis K. Akturk
- School of Medicine, University of Colorado Denver, Aurora, Colorado
- Barbara Davis Center for Diabetes, Aurora, Colorado
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