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Manzoni M, Minotti D, Toletti G, Boaretto A. Exploring usability metrics in continuous glucose monitoring systems: insights from the voice of people with diabetes in Italy. FRONTIERS IN CLINICAL DIABETES AND HEALTHCARE 2025; 6:1472471. [PMID: 40181799 PMCID: PMC11966498 DOI: 10.3389/fcdhc.2025.1472471] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 07/29/2024] [Accepted: 02/10/2025] [Indexed: 04/05/2025]
Abstract
Introduction Continuous Glucose Monitoring (CGM) systems are crucial in diabetes management, offering clinical and psychological benefits despite operational challenges. Usability assessment of real-time and intermittently-scanned CGM systems is a notable research gap. This study, in collaboration with diabetes patient associations, explores CGM usability from the perspective of Italian individuals with diabetes. Methods A roundtable discussion with patient association representatives was conducted to discuss CGM usability, followed by a detailed online survey of 281 Italian patients on CGM usage, satisfaction, and feature preferences. Results Findings show a significant positive impact on Quality of Life (87/100) and moderate usability (66/100). Core CGM functions are widely used, while data sharing with healthcare professionals is underutilized. The study offers diverse insights into CGM usability from both the roundtable and survey data. Conclusions The study underscores the importance of CGM in diabetes management and highlights the need for continuous technological improvements. It emphasizes the role of patient associations in enhancing communication with manufacturers and CGM education. Effective collaboration between healthcare professionals and patients is vital for optimal CGM use, advocating for personalized care strategies tailored to individual patient needs.
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Affiliation(s)
- Martina Manzoni
- Department of Management, Economics and Industrial Engineering, Politecnico di Milano, Milan, Italy
| | - Davide Minotti
- Department of Management, Economics and Industrial Engineering, Politecnico di Milano, Milan, Italy
| | - Giovanni Toletti
- Department of Management, Economics and Industrial Engineering, Politecnico di Milano, Milan, Italy
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2
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Meighan S, Lipman TH, VanGraafeiland B, Marks BE. Continuous Glucose Monitoring Attrition in Youth With Type 1 Diabetes. Sci Diabetes Self Manag Care 2025; 51:64-72. [PMID: 39783011 PMCID: PMC12013585 DOI: 10.1177/26350106241306058] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/12/2025]
Abstract
PURPOSE The purpose of the study was to identify the most common reasons for and timing of continuous glucose monitoring (CGM) attrition in youth with type 1 diabetes (T1DM). METHODS This single center retrospective chart review included youth with T1DM <22 years seen between November 1, 2021, and October 31, 2022. Data were gathered from CGM cloud-based software and the electronic medical record. RESULTS Among 2663 youth, 88.3% (n = 2351) actively used CGM, and 5.9% (n = 311) had CGM attrition. Those who discontinued CGM were older (17.0 vs 14.9 years, P = .0001), had a longer T1DM duration (7.4 vs 5.1 years), higher A1C (9% vs 7.4%), and were non-Hispanic Black (NHB; 34.0% vs 11.5%). The odds of CGM attrition were 5.0 and 2.8 times higher in NHB and Latine youth, respectively, compared to non-Hispanic White youth. Median time to CGM discontinuation was 4 months, 21 days after initiation; 57% of youth who discontinued did so in the first 6 months of use. The most common reasons for CGM attrition were problems with device adhesion (18.4%), dislike device on the body (10.8%), insurance problems (9.5%), pain with device use (8.3%), and system mistrust due to inaccurate readings (8.2%). NHB and Latine youth were more likely to discontinue CGM due to insurance problems (3.2% vs 15.1% vs 16.7%). CONCLUSIONS To support equitable, uninterrupted CGM use, education at CGM initiation should address practical approaches to improve adhesion and wearability and provide a clear pathway to obtaining supplies. Interventions to support sustained CGM use should occur within the first 6 months of initiation.
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Affiliation(s)
- Seema Meighan
- Division of Endocrinology and Diabetes, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
| | - Terri H Lipman
- Division of Endocrinology and Diabetes, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
| | | | - Brynn E Marks
- Division of Endocrinology and Diabetes, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
- Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania
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3
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Noor N, Norman G, Sonabend R, Chao L, Kamboj M, Golden L, Bekx MT, Hseih S, Levy C, Sanchez J, Rapaport R, Ebekozien O. An Observational Crossover Study of People Using Real-Time Continuous Glucose Monitors Versus Self-Monitoring of Blood Glucose: Real-World Evidence Using Electronic Medical Record Data From More Than 12,000 People With Type 1 Diabetes. J Diabetes Sci Technol 2025; 19:63-71. [PMID: 37264642 PMCID: PMC11688696 DOI: 10.1177/19322968231178017] [Citation(s) in RCA: 4] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 06/03/2023]
Abstract
BACKGROUND We used real-world electronic health record (EHR) data to examine HbA1c levels among children and adults with type 1 diabetes (T1D) who are classified as continuous glucose monitor (CGM) users after T1D diagnosis and switch to self-monitoring of blood glucose (SMBG) during follow-up, versus people who opt for SMBG after T1D diagnosis and switch to CGM during follow-up visits. METHODS We conducted an observational, case-crossover study using electronic medical record (EMR) data from the T1D Exchange Quality Improvement Collaborative. The primary outcome in this study was HbA1c. Baseline HbA1c levels were taken at the index date, corresponding to initial device classification, and compared with HbA1c value recorded at the clinic visit following device switch. RESULTS Of all patients classified in the SMBG group, 7,706 switched to CGM use within the 5-year study time frame, and 5,123 of all initial CGM users switched to SMBG within the study time frame and were included in this analysis. At baseline, median (interquartile range [IQR]) HbA1c for SMBG use was 8.1 (2.4), whereas postcrossover to CGM use, there was a decline in median (IQR) levels to 7.7 (1.9) (P < .001). For baseline CGM users, median (IQR) HbA1c levels were 7.9 (2.0), and postcrossover to SMBG, median (IQR) HbA1c levels increased to 8.0 (2.9) (P < .001). CONCLUSION We found that people who switched to CGM use had significantly improved HbA1c levels compared to those who switched to glucose monitoring with SMBG.
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Affiliation(s)
| | | | - Rona Sonabend
- Texas Children’s Hospital, Baylor College of Medicine, Houston, TX, USA
| | - Lily Chao
- Children’s Hospital of Los Angeles, Los Angeles, CA, USA
| | | | | | - M. Tracy Bekx
- UW Health, University of Wisconsin, Madison, WI, USA
| | - Susan Hseih
- Cook Children’s Hospital, Fort Worth, TX, USA
| | - Carol Levy
- Icahn School of Medicine, New York City, NY, USA
| | - Janine Sanchez
- Miller School of Medicine, University of Miami, Miami, FL, USA
| | | | - Osagie Ebekozien
- T1D Exchange, Boston, MA, USA
- School of Population Health, University of Mississippi, University, MS, USA
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Sharafieh R, Qiao Y, Godlewski I, Czajkowski C, Wu R, Hargis GR, Kreutzer D, Klueh U. Impact of Bindarit, a CCL2 Chemokine Synthesis Inhibitor, on Macrophage-Based Biofouling and Continuous Glucose Monitoring in vivo. BIOSENSORS & BIOELECTRONICS: X 2024; 19:100511. [PMID: 39703931 PMCID: PMC11654743 DOI: 10.1016/j.biosx.2024.100511] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/21/2024]
Abstract
Continuous glucose monitoring (CGM) using implantable glucose sensors is a critical tool in the management of diabetes. Unfortunately, current commercial glucose sensors have limited performance and lifespans in vivo, considered to be due to sensor-induced tissue reactions (inflammation, fibrosis, and vessel regression). Previously, our laboratory utilized monocyte/macrophage (Mo/MQ) deficient and depleted mice to establish a causal relationship between Mo/MQ accumulation and inflammation in glucose sensor performance in vivo. Using C-C chemokine ligand-2 (CCL2) and C-C chemokine receptor-2 (CCR2) knockout mice, we next established that deletion of this Mo/MQ chemokine family, suppressed inflammation at the sensor-tissue interface in these mice, while improving sensor performance over a 4-week post-sensor implantation, compared to normal mice. These studies underscore the importance of the CCL2 family of chemokines and receptors in Mo/MQ recruitment/activation, and sensor performance in vivo. In the present study, we systemically administered Bindarit, a CCL2 synthesis inhibitor, to assess the role of CCL2 chemokines, Mo/MQ recruitment and inflammation at sensor implantation sites, on CGM performance in vivo. These studies demonstrate that systemic administration of Bindarit substantially reduced sensor-induced inflammation, particularly MQ recruitment, preventing sensor biofouling in our CGM mouse model. These results not only confirm the major role monocytes/macrophages play, but directly demonstrate that CCL2 drives Mo/MQ recruitment and biofouling of glucose sensors in vivo. These findings support future studies incorporating Mo/MQ migration/chemotaxis inhibitors, like CCL2, on sensor coatings to improve glucose sensor accuracy and lifespan in vivo.
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Affiliation(s)
- Roshanak Sharafieh
- Department of Surgery, University of Connecticut School of Medicine, 263 Farmington Avenue, Farmington, 06030, CT, USA
- Cell and Molecular Tissue Engineering LLC, 14 Highwood Drive, Avon, 06001, CT, USA
| | - Yi Qiao
- Department of Surgery, University of Connecticut School of Medicine, 263 Farmington Avenue, Farmington, 06030, CT, USA
- Cell and Molecular Tissue Engineering LLC, 14 Highwood Drive, Avon, 06001, CT, USA
| | - Izabela Godlewski
- Department of Surgery, University of Connecticut School of Medicine, 263 Farmington Avenue, Farmington, 06030, CT, USA
| | - Caroline Czajkowski
- Department of Surgery, University of Connecticut School of Medicine, 263 Farmington Avenue, Farmington, 06030, CT, USA
| | - Rong Wu
- Biostatistics Center, Connecticut Convergence Institute for Translation in Regenerative Engineering, University of Connecticut School of Medicine, 263 Farmington Avenue, Farmington, 06030, CT, USA
| | - Geneva R. Hargis
- Calibr-Skaggs at Scripps Research, 11119 N Torrey Pines Rd, La Jolla, 92037, CA, USA
| | - Don Kreutzer
- Department of Surgery, University of Connecticut School of Medicine, 263 Farmington Avenue, Farmington, 06030, CT, USA
- Cell and Molecular Tissue Engineering LLC, 14 Highwood Drive, Avon, 06001, CT, USA
| | - Ulrike Klueh
- Cell and Molecular Tissue Engineering LLC, 14 Highwood Drive, Avon, 06001, CT, USA
- Department of Biomedical Engineering, Wayne State University, 818 W. Hancock, Detroit, 48201 MI, USA
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Malik FS, Perez SG, Lowry S, Weaver KW, Hirsch IB, Pihoker C, Moss AC, Ehrhardt N, Roberts AJ. Improving Continuous Glucose Monitoring Use in Emerging Adults With Type 1 Diabetes. Clin Diabetes 2024; 42:570-573. [PMID: 39429462 PMCID: PMC11486856 DOI: 10.2337/cd23-0104] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/22/2024]
Abstract
Quality Improvement Success Stories are published by the American Diabetes Association in collaboration with the American College of Physicians and the National Diabetes Education Program. This series is intended to highlight best practices and strategies from programs and clinics that have successfully improved the quality of care for people with diabetes or related conditions. Each article in the series is reviewed and follows a standard format developed by the editors of Clinical Diabetes. The following article describes a quality improvement project focused on increasing the use of continuous glucose monitoring among emerging adults with type 1 diabetes enrolled in a health care transition program in the state of Washington.
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Affiliation(s)
- Faisal S. Malik
- Department of Pediatrics, University of Washington School of Medicine, Seattle, WA
- Seattle Children’s Research Institute, Seattle, WA
| | | | - Sarah Lowry
- Seattle Children’s Research Institute, Seattle, WA
| | - Kathryn W. Weaver
- Department of Medicine, University of Washington School of Medicine, Seattle, WA
- UW Medicine Diabetes Institute, University of Washington, Seattle, WA
| | - Irl B. Hirsch
- Department of Medicine, University of Washington School of Medicine, Seattle, WA
- UW Medicine Diabetes Institute, University of Washington, Seattle, WA
| | - Catherine Pihoker
- Department of Pediatrics, University of Washington School of Medicine, Seattle, WA
- Seattle Children’s Research Institute, Seattle, WA
| | - Ashley C. Moss
- Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA
| | - Nicole Ehrhardt
- Department of Medicine, University of Washington School of Medicine, Seattle, WA
- UW Medicine Diabetes Institute, University of Washington, Seattle, WA
| | - Alissa J. Roberts
- Department of Pediatrics, University of Washington School of Medicine, Seattle, WA
- Seattle Children’s Research Institute, Seattle, WA
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Zoccarato F, Manzoni M, Minotti D, Lettieri E, Boaretto A. Unveiling the interplay between rational, psychological and functional factors in continuous glucose monitoring early adoption: Novel evidence from the Dexcom ONE case in Italy. BMC Health Serv Res 2024; 24:747. [PMID: 38890619 PMCID: PMC11186290 DOI: 10.1186/s12913-024-11195-6] [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: 03/06/2024] [Accepted: 06/12/2024] [Indexed: 06/20/2024] Open
Abstract
BACKGROUND The escalating prevalence of diabetes, with its multifaceted complications, poses a pressing challenge for healthcare systems globally. In response, the advent of continuous glucose monitoring (CGM) systems, offering technological solutions for daily diabetes management, presents significant opportunities. However, the widespread adoption faces several barriers, linked both to the technological configuration of the devices and to the psychological dimension of patients. Therefore, this study aims to apply and test a theoretical model that investigates the antecedents of the intention to use Continuous Glucose Monitoring systems. METHODS The research model was built to unveil the impacts of psychological factors, functional components and rational constructs derived from the Technology Acceptance Model (TAM) on CGM systems sustained adoption. To ensure the comparability of results, we have collected data from people who had used Dexcom ONE Dexcom (San Diego, CA) for the first time for at least one month. Employing Structural Equation Modelling (SEM) techniques, the hypothesized relationships among constructs were assessed. RESULTS The analyses confirmed the positive correlation of rational factors to the Intention to Use. Subjective Norm, intended as the physicians' influence, is positively correlated with the Perceived Usefulness. Trend Arrows, albeit being negatively correlated with Perceived Usefulness, have a positive correlation on Perceived Ease Of Use, reinforcing its mediating effect towards Perceived Usefulness. Among psychological factors, Trust in the CGM technology positively correlates with Intention to Use. Health Literacy is negatively correlated to the Intention to Use. CONCLUSIONS These findings contribute to theoretical and managerial understanding, providing recommendations to enhance the adoption of CGM systems like Dexcom ONE.
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Affiliation(s)
- Francesca Zoccarato
- Department of Management, Economics and Industrial Engineering, Politecnico di Milano, Via Lambruschini 4/B, Milan, 20156, Italy.
| | - Martina Manzoni
- Department of Management, Economics and Industrial Engineering, Politecnico di Milano, Via Lambruschini 4/B, Milan, 20156, Italy
| | - Davide Minotti
- Department of Management, Economics and Industrial Engineering, Politecnico di Milano, Via Lambruschini 4/B, Milan, 20156, Italy
| | - Emanuele Lettieri
- Department of Management, Economics and Industrial Engineering, Politecnico di Milano, Via Lambruschini 4/B, Milan, 20156, Italy
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7
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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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8
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Garretson S, Parmar A, Streisand R, Jaser S, Datye K. Updating Our Understanding of Device Use in Adolescents: Demographic Factors and Preferences in a Group of Adolescents With Type 1 Diabetes. Sci Diabetes Self Manag Care 2024; 50:9-18. [PMID: 38240246 PMCID: PMC10851623 DOI: 10.1177/26350106231220023] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2024]
Abstract
PURPOSE The purpose of the study was to identify demographic factors associated with continuous glucose monitor (CGM) and automated insulin delivery (AID) use among adolescents with type 1 diabetes and to explore why adolescents may start and stop using CGMs. METHODS Adolescents ages 13 to 17 and caregivers completed demographic and device use surveys at baseline for a randomized trial of a behavioral intervention conducted at 2 large medical centers in the United States. This study is a secondary analysis of the demographic and device use data. RESULTS The study sample consisted of 198 participants ages 13 to 17, 58% female, 57% non-Hispanic White, 24% non-Hispanic Black, 19% other race and ethnicity. Eighty-one percent of adolescents were using CGM, and 10% reported past use. Forty percent of adolescents reported taking CGM breaks ranging hours to weeks. Higher CGM use was found in higher income families (>$90 000). No difference in CGM use was observed related to race or ethnicity. CONCLUSIONS These findings suggest CGM use is increasing even among adolescents, a group that historically has had the lowest device use. However, adolescents often take CGM breaks, and it is not clear if they adjust their diabetes management during these times. It is important for providers to understand when and why patients may take CGM breaks so education about diabetes management while off CGM can occur. Further investigation into management during CGM breaks, particularly in those using an AID system, is needed.
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Affiliation(s)
| | - Angelee Parmar
- Vanderbilt University Medical Center, Nashville, Tennessee
| | - Randi Streisand
- The George Washington University School of Medicine, Washington, District of Columbia
- Children's National Hospital, Washington, District of Columbia
| | - Sarah Jaser
- Vanderbilt University Medical Center, Nashville, Tennessee
| | - Karishma Datye
- Vanderbilt University Medical Center, Nashville, Tennessee
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Jefferies CA, Boucsein A, Styles SE, Chamberlain B, Michaels VR, Crockett HR, De Lange M, Lala A, Cunningham V, Wiltshire EJ, Serlachius AS, Wheeler BJ. Effects of 12-Week Freestyle Libre 2.0 in Children with Type 1 Diabetes and Elevated HbA1c: A Multicenter Randomized Controlled Trial. Diabetes Technol Ther 2023; 25:827-835. [PMID: 37782139 DOI: 10.1089/dia.2023.0292] [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: 10/03/2023]
Abstract
Objective: To investigate whether intermittently scanned continuous glucose monitoring (isCGM) reduced glycated hemoglobin (HbA1c) compared with capillary self-monitored capillary blood glucose (SMBG) in children with type 1 diabetes (T1D) and elevated glycemic control. Research Design and Methods: This multicenter 12-week 1:1 randomized, controlled, parallel-arm trial included 100 participants with established T1D aged 4-13 years (mean 10.9 ± 2.3 years) naive to isCGM and with elevated HbA1c 7.5%-12.2% [58-110 mmol/mol] [mean HbA1c was 9.05 (1.3)%] [75.4 (13.9) mmol/mol]. Participants were allocated to 12-week intervention (isCGM; FreeStyle Libre 2.0; Abbott Diabetes Care, Witney, United Kingdom) (n = 49) or control (SMBG; n = 51). The primary outcome was the difference in change of HbA1c from baseline to 12 weeks. Results: There was no evidence of a difference between groups for change in HbA1c at 12 weeks (0.23 [95% confidence interval; CI: -0.21 to 0.67], P = 0.3). However, glucose-monitoring frequency increased with isCGM +4.89/day (95% CI 2.97-6.81; P < 0.001). Percent time below range (TBR) <3.9 mmol/L (70-180 mg/dL) was reduced with isCGM -6.4% (10.6 to -4.2); P < 0.001. There were no differences in within group changes for Parent or Child scores of psychosocial outcomes at 12 weeks. Conclusions: For children aged 4-13 years with elevated Hba1c isCGM led to improvements in glucose testing frequency and reduced time below range. However, isCGM did not translate into reducing Hba1c or psychosocial outcomes compared to usual care over 12-weeks. The trial is registered within the Australian New Zealand Trial Registry on February 19, 2020 (ACTRN12620000190909p; ANZCTR.org.au) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1237-0090).
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Affiliation(s)
- Craig A Jefferies
- Starship Child Health, Te Whatu Ora-Health New Zealand, Te Toka Tumai Auckland, Auckland, New Zealand
- Liggins Institute and Department of Paediatrics, The University of Auckland, Auckland, New Zealand
| | - Alisa Boucsein
- Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand
| | - Sara E Styles
- Department of Human Nutrition, University of Otago, Dunedin, New Zealand
| | - Bronte Chamberlain
- Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand
- Department of Pediatrics, Te Whatu Ora Health New Zealand-Southern, Auckland, New Zealand
| | - Venus R Michaels
- Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand
- Department of Pediatrics, Te Whatu Ora Health New Zealand-Southern, Auckland, New Zealand
| | - Hamish R Crockett
- Health, Sport and Human Performance, School of Health, University of Waikato, Hamilton, New Zealand
| | - Michel De Lange
- Pacific Edge Ltd., Centre for Innovation, Dunedin, New Zealand
| | - Anita Lala
- Department of Paediatrics, Te Whatu Ora Health New Zealand-Hauora a Toi, Bay of Plenty, Tauranga, New Zealand
| | - Vicki Cunningham
- Department of Paediatrics, Te Whatu Ora Health New Zealand New Zealand, Te Tai Tokerau, Whangarei, New Zealand
| | - Esko J Wiltshire
- Department of Paediatrics, Te Whatu Ora Health New Zealand-Capital, Coast and Hutt Valley, Wellington, New Zealand
- Department of Paediatrics and Child Health, University of Otago, Wellington, Wellington, New Zealand
| | - Anna S Serlachius
- Psychological Medicine, The University of Auckland, Auckland, New Zealand
| | - Benjamin J Wheeler
- Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand
- Department of Pediatrics, Te Whatu Ora Health New Zealand-Southern, Auckland, New Zealand
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Miller KM, Bauza C, Kanapka LG, Clements MA, DeSalvo DJ, Hood K, Messer LH, Sherr J, Bergamo K, Criego A, Freiner E, Lyons SK, Monzavi R, Moore W, Prahalad P, Simmons JH, Sulik M, Wadwa RP, Weinstock RS, Willi SM, Williams K, Laffel LM, for the CITY Study Group. Continuous Glucose Monitoring Provides Durable Glycemic Benefit in Adolescents and Young Adults with Type 1 Diabetes: 12-Month Follow-Up Results. Pediatr Diabetes 2023; 2023:6718115. [PMID: 40303270 PMCID: PMC12016685 DOI: 10.1155/2023/6718115] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/30/2022] [Revised: 08/08/2023] [Accepted: 09/13/2023] [Indexed: 05/02/2025] Open
Abstract
Objective To further evaluate glycemic outcomes during the observational extension phase of the Continuous Glucose Monitoring (CGM) Intervention for Teens and Young Adults randomized clinical trial (RCT). Subjects and Methods. Following a 26-week RCT comparing CGM with blood glucose monitoring (BGM) in 153 adolescents and young adults aged 14 to <25 years old with suboptimally controlled type 1 diabetes, 70 (89%) participants in the BGM group initiated use of CGM (referred to as BGM-CGM cohort), and 70 (95%) participants in the CGM group continued to use of CGM (CGM-CGM cohort) for an additional 26 weeks. Results In the CGM-CGM cohort, mean hemoglobin A1c (HbA1c) decreased from 8.9% ± 0.9% (74 ± 9.8 mmol/mol) at randomization to 8.3% ± 1.3% (67 ± 14.2 mmol/mol) at 52 weeks (p < 0.001); however, significant improvement in time in target range (TIR) 70-180 mg/dL was not observed from prerandomization (38% ± 13%) to 52 weeks (41% ± 18%). Median percent time <70 mg/dL decreased from 3.0% before randomization to 1.1% at 52 weeks (p < 0.001). In the BGM-CGM cohort, mean HbA1c decreased from 8.9% ± 1.2% (74 ± 13.1 mmol/mol) before CGM initiation to 8.5% ± 1.3% (69 ± 14.2 mmol/mol) after 26 weeks of CGM use (p < 0.001) and mean TIR increased from 34% ± 12% to 38% ± 15% (p=0.01). The median percent time <70 mg/dL decreased from 3.3% before CGM initiation to 1.2% after 26 weeks of CGM use (p < 0.001). No participants discontinued CGM use during the extension phase. Conclusions This further evaluation of CGM supports the findings of the preceding RCT that use of CGM improves glycemic control and reduces hypoglycemia in adolescents and young adults with type 1 diabetes. This trial is registered with NCT03263494.
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Affiliation(s)
| | | | | | | | | | | | - Laurel H. Messer
- Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO, USA
| | | | - Katherine Bergamo
- University of North Carolina Diabetes Care Center, Chapel Hill, NC, USA
| | - Amy Criego
- Health Partners Institute, International Diabetes Center, St. Louis Park, MN, USA
| | - Emily Freiner
- Joslin Diabetes Center, Harvard Medical School, Boston, MA, USA
| | | | | | - Wayne Moore
- Children's Mercy Hospital, Kansas City, MO, USA
| | | | | | - Mark Sulik
- Rocky Mountain Diabetes & Osteoporosis Center, Idaho Falls, ID, USA
| | - R. Paul Wadwa
- Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO, USA
| | | | | | - Kristen Williams
- Naomi Berrie Diabetes Center, Columbia University, New York City, NY, USA
| | - Lori M. Laffel
- Joslin Diabetes Center, Harvard Medical School, Boston, MA, USA
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11
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Jabari M. Efficacy and safety of closed-loop control system for type one diabetes in adolescents a meta analysis. Sci Rep 2023; 13:13165. [PMID: 37574494 PMCID: PMC10423718 DOI: 10.1038/s41598-023-40423-y] [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] [Received: 03/12/2023] [Accepted: 08/10/2023] [Indexed: 08/15/2023] Open
Abstract
This meta-analysis compares the efficacy and safety of Closed-Loop Control (CLC) to Sensor-Augmented Insulin Pump (SAP) for adolescent patients with Type 1 Diabetes Mellitus (T1DM). Eleven randomized-controlled trials were included with a total of 570 patients, from a total of 869 articles found adhering to PRISMA guidelines. The efficacy of the therapies were evaluated from the day, night and during physical activities monitoring of the of the mean blood glucose (BG), Time In Range (TIR), and Standard Deviation (SD) of the glucose variability. The safety measure of the therapies, was assessed from the day and night recording of the hypoglycemic and hyperglycemic events occurred. Pooled results of comparison of mean BG values for day, night and physical activities, - 4.33 [- 6.70, - 1.96] (P = 0.0003), - 16.61 [- 31.68, - 1.54] (P = 0.03) and - 8.27 [- 19.52, 2.99] (P = 0.15). The monitoring for day, night and physical activities for TIR - 13.18 [- 19.18, - 7.17] (P < 0.0001), - 15.36 [- 26.81, - 3.92] (P = 0.009) and - 7.39 [- 17.65, 2.87] (P = 0.16). The day and night results of SD of glucose variability was - 0.40 [- 0.79, - 0.00] (P = 0.05) and - 0.86 [- 2.67, 0.95] (P = 0.35). These values shows the superiority of CLC system in terms of efficacy. The safety evaluation, of the day, night and physical activities observations of average blood glucose goal hypoglycemic events - 0.54 [- 1.86, 0.79] (P = 0.43), 0.04 [- 0.20, 0.27] (P = 0.77) and 0.00 [- 0.25, 0.25] (P = 1.00) and hyperglycemic events - 0.04 [- 0.20, 0.27] (P = 0.77), - 7.11 [- 12.77, - 1.45] (P = 0.01) and - 0.00 [- 0.10, 0.10] (P = 0.97), highlights the commendable safety factor of CLC. The CLC systems can be considered as an ideal preference in the management of adolescents with type 1 diabetes to be used during a 24 h basis.
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Affiliation(s)
- Mosleh Jabari
- Department of Pediatrics, Imam Mohammed Ibn Saud Islamic University, An Nada, 13317, Riyadh, Saudi Arabia.
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Diaz-Thomas AM, Golden SH, Dabelea DM, Grimberg A, Magge SN, Safer JD, Shumer DE, Stanford FC. Endocrine Health and Health Care Disparities in the Pediatric and Sexual and Gender Minority Populations: An Endocrine Society Scientific Statement. J Clin Endocrinol Metab 2023; 108:1533-1584. [PMID: 37191578 PMCID: PMC10653187 DOI: 10.1210/clinem/dgad124] [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: 02/24/2023] [Indexed: 05/17/2023]
Abstract
Endocrine care of pediatric and adult patients continues to be plagued by health and health care disparities that are perpetuated by the basic structures of our health systems and research modalities, as well as policies that impact access to care and social determinants of health. This scientific statement expands the Society's 2012 statement by focusing on endocrine disease disparities in the pediatric population and sexual and gender minority populations. These include pediatric and adult lesbian, gay, bisexual, transgender, queer, intersex, and asexual (LGBTQIA) persons. The writing group focused on highly prevalent conditions-growth disorders, puberty, metabolic bone disease, type 1 (T1D) and type 2 (T2D) diabetes mellitus, prediabetes, and obesity. Several important findings emerged. Compared with females and non-White children, non-Hispanic White males are more likely to come to medical attention for short stature. Racially and ethnically diverse populations and males are underrepresented in studies of pubertal development and attainment of peak bone mass, with current norms based on European populations. Like adults, racial and ethnic minority youth suffer a higher burden of disease from obesity, T1D and T2D, and have less access to diabetes treatment technologies and bariatric surgery. LGBTQIA youth and adults also face discrimination and multiple barriers to endocrine care due to pathologizing sexual orientation and gender identity, lack of culturally competent care providers, and policies. Multilevel interventions to address these disparities are required. Inclusion of racial, ethnic, and LGBTQIA populations in longitudinal life course studies is needed to assess growth, puberty, and attainment of peak bone mass. Growth and development charts may need to be adapted to non-European populations. In addition, extension of these studies will be required to understand the clinical and physiologic consequences of interventions to address abnormal development in these populations. Health policies should be recrafted to remove barriers in care for children with obesity and/or diabetes and for LGBTQIA children and adults to facilitate comprehensive access to care, therapeutics, and technological advances. Public health interventions encompassing collection of accurate demographic and social needs data, including the intersection of social determinants of health with health outcomes, and enactment of population health level interventions will be essential tools.
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Affiliation(s)
- Alicia M Diaz-Thomas
- Department of Pediatrics, Division of Endocrinology, University of Tennessee Health Science Center, Memphis, TN 38163, USA
| | - Sherita Hill Golden
- Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA
- Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA
| | - Dana M Dabelea
- Department of Epidemiology, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA
| | - Adda Grimberg
- Department of Pediatrics, Division of Endocrinology and Diabetes, Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Sheela N Magge
- Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA
| | - Joshua D Safer
- Department of Medicine, Division of Endocrinology, Diabetes, and Bone Disease, Icahn School of Medicine at Mount Sinai, New York, NY 10001, USA
| | - Daniel E Shumer
- Department of Pediatric Endocrinology, C.S. Mott Children's Hospital, University of Michigan School of Medicine, Ann Arbor, MI 48109, USA
| | - Fatima Cody Stanford
- Massachusetts General Hospital, Department of Medicine-Division of Endocrinology-Neuroendocrine, Department of Pediatrics-Division of Endocrinology, Nutrition Obesity Research Center at Harvard (NORCH), Boston, MA 02114, USA
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Beck JK, Allen RA, Jeter KM, Fisher RS, Dattilo TM, Traino KA, Anderson M, Cutler J, Sparling DP. Real-Time Continuous Glucose Monitoring Reduced Costly Diabetes-Related Events in Adolescents and Young Adults despite Lack of Short-Term Reduction in Hemoglobin A1c. Pediatr Diabetes 2023; 2023:5253515. [PMID: 40303275 PMCID: PMC12017084 DOI: 10.1155/2023/5253515] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/18/2023] [Revised: 03/06/2023] [Accepted: 03/25/2023] [Indexed: 05/02/2025] Open
Abstract
Real-time continuous glucose monitoring (rtCGM) can directly improve patient outcomes, including decreased health care system utilization and associated costs. The purpose of this study was to evaluate the clinical benefits of rtCGM use in a high-risk, under-resourced cohort of adolescents and young adults (AYA) with type 1 diabetes (T1D) who had no prior access to rtCGM. The effects of rtCGM use on hemoglobin A1c (A1c) and the frequency of health care events (i.e., diabetes-related emergency room (ER) visits, hospitalizations, emergency medical services (EMS), and after-hour emergency calls) were evaluated regarding payor costs in 33 AYA with ≥70% rtCGM use. Secondary aims included the evaluation of a phone-based pattern management intervention. The frequency of health care events decreased at 12 and 24 weeks for all participants, and there was no significant difference by treatment group. We estimated that the use of rtCGM in this cohort results in a projected annualized cost-savings of $195,943 to $294,864 or 43-65% per year based on Medicare or list pricing for rtCGM, respectively. Results also revealed improvements in A1c at 12 weeks for all study participants, but this was not maintained at 24 weeks for the phone-based pattern management intervention group. Our findings suggest that rtCGM may be an effective tool for reducing diabetes-related events and underscores the importance of access. Future studies are needed to further examine tailored interventions and support to optimize rtCGM use and glycemic health in high-risk AYA.
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Affiliation(s)
- Joni K. Beck
- Section of Pediatric Diabetes & Endocrinology, University of Oklahoma Health Sciences Center and the OU Health Harold Hamm Diabetes Center, Oklahoma City, OK, USA
| | - Rebecca A. Allen
- Section of Pediatric Diabetes & Endocrinology, University of Oklahoma Health Sciences Center and the OU Health Harold Hamm Diabetes Center, Oklahoma City, OK, USA
| | - Kathryn M. Jeter
- Section of General & Community Pediatrics, University of Oklahoma Health Sciences Center and the OU Health Harold Hamm Diabetes Center, Oklahoma City, OK, USA
| | - Rachel S. Fisher
- Department of Psychology, Oklahoma State University, Stillwater, OK, USA
| | - Taylor M. Dattilo
- Department of Psychology, Oklahoma State University, Stillwater, OK, USA
| | | | - Michael Anderson
- Department of Biostatistics and Epidemiology, College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA
| | - James Cutler
- Department of Biostatistics and Epidemiology, College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA
| | - David P. Sparling
- Section of Pediatric Diabetes & Endocrinology, University of Oklahoma Health Sciences Center and the OU Health Harold Hamm Diabetes Center, Oklahoma City, OK, USA
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de Vries SAG, Bak JCG, Verheugt CL, Stangenberger VA, Mul D, Wouters MWJM, Nieuwdorp M, Sas TCJ. Healthcare expenditure and technology use in pediatric diabetes care. BMC Endocr Disord 2023; 23:72. [PMID: 37029362 PMCID: PMC10080182 DOI: 10.1186/s12902-023-01316-3] [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] [Received: 10/13/2022] [Accepted: 03/06/2023] [Indexed: 04/09/2023] Open
Abstract
BACKGROUND Diabetes mellitus is one of the most common chronic diseases in childhood. With more advanced care options including ever-evolving technology, allocation of resources becomes increasingly important to guarantee equal care for all. Therefore, we investigated healthcare resource utilization, hospital costs, and its determinants in Dutch children with diabetes. METHODS We conducted a retrospective, observational analysis with hospital claims data of 5,474 children with diabetes mellitus treated in 64 hospitals across the Netherlands between 2019-2020. RESULTS Total hospital costs were €33,002,652 per year, and most of these costs were diabetes-associated (€28,151,381; 85.3%). Mean annual diabetes costs were €5,143 per child, and treatment-related costs determined 61.8%. Diabetes technology significantly increased yearly diabetes costs compared to no technology: insulin pumps € 4,759 (28.7% of children), Real-Time Continuous Glucose Monitoring € 7,259 (2.1% of children), and the combination of these treatment modalities € 9,579 (27.3% of children). Technology use increased treatment costs significantly (5.9 - 15.3 times), but lower all-cause hospitalisation rates were observed. In all age groups, diabetes technology use influenced healthcare consumption, yet in adolescence usage decreased and consumption patterns changed. CONCLUSIONS These findings suggest that contemporary hospital costs of children with diabetes of all ages are driven primarily by the treatment of diabetes, with technology use as an important additive factor. The expected rise in technology use in the near future underlines the importance of insight into resource use and cost-effectiveness studies to evaluate if improved outcomes balance out these short-term costs of modern technology.
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Affiliation(s)
- Silvia A G de Vries
- Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
- Dutch Institute for Clinical Auditing, Leiden, The Netherlands.
| | - Jessica C G Bak
- Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, The Netherlands
- Dutch Institute for Clinical Auditing, Leiden, The Netherlands
| | - Carianne L Verheugt
- Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, The Netherlands
| | | | - Dick Mul
- Diabeter, Center for Pediatric and Adult Diabetes Care and Research, Rotterdam, The Netherlands
| | - Michel W J M Wouters
- Dutch Institute for Clinical Auditing, Leiden, The Netherlands
- Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands
| | - Max Nieuwdorp
- Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, The Netherlands
| | - Theo C J Sas
- Diabeter, Center for Pediatric and Adult Diabetes Care and Research, Rotterdam, The Netherlands
- Department of Pediatrics, Division of Pediatric Endocrinology, Erasmus University Medical Center, Sophia Children's Hospital, Rotterdam, The Netherlands
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Naguib MN, Hegedus E, Raymond JK, Goran MI, Salvy SJ, Wee CP, Durazo-Arvizu R, Moss L, Vidmar AP. Continuous Glucose Monitoring in Adolescents With Obesity: Monitoring of Glucose Profiles, Glycemic Excursions, and Adherence to Time Restricted Eating Programs. Front Endocrinol (Lausanne) 2022; 13:841838. [PMID: 35282464 PMCID: PMC8914373 DOI: 10.3389/fendo.2022.841838] [Citation(s) in RCA: 21] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/22/2021] [Accepted: 02/03/2022] [Indexed: 01/21/2023] Open
Abstract
Background Randomized controlled trials of time restricted eating (TRE) in adults have demonstrated improvements in glucose variability as captured by continuous glucose monitors (CGM). However, little is known about the feasibility of CGM use in TRE interventions in adolescents, or the expected changes in glycemic profiles in response to changes in meal-timing. As part of a pilot trial of TRE in adolescents with obesity, this study aimed to 1) assess the feasibility of CGM use, 2) describe baseline glycemic profiles in adolescents with obesity, without diabetes, and 3) compare the difference between glycemic profiles in groups practicing TRE versus control. Methods This study leverages data from a 12-week pilot trial (ClinicalTrials.gov Identifier: NCT03954223) of late TRE in adolescents with obesity compared to a prolonged eating window. Feasibility of CGM use was assessed by monitoring 1) the percent wear time of the CGM and 2) responses to satisfaction questionnaires. A computation of summary measures of all glycemic data prior to randomization was done using EasyGV and R. Repeat measures analysis was conducted to assess the change in glycemic variability over time between groups. Review of CGM tracings during periods of 24-hour dietary recall was utilized to describe glycemic excursions. Results Fifty participants were enrolled in the study and 43 had CGM and dietary recall data available (16.4 + 1.3 years, 64% female, 64% Hispanic, 74% public insurance). There was high adherence to daily CGM wear (96.4%) without negative impacts on daily functioning. There was no significant change in the glycemic variability as measured by standard deviation, mean amplitude glycemic excursion, and glucose area under the curve over the study period between groups. Conclusions CGM use appears to be a feasible and acceptable tool to monitor glycemic profiles in adolescents with obesity and may be a helpful strategy to confirm TRE dosage by capturing glycemic excursions compared to self-reported meal timing. There was no effect of TRE on glucose profiles in this study. Further research is needed to investigate how TRE impacts glycemic variability in this age group and to explore if timing of eating window effects these findings.
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Affiliation(s)
- Monica N. Naguib
- Department of Pediatrics, Center for Endocrinology, Diabetes, and Metabolism, Children’s Hospital Los Angeles, Los Angeles, CA, United States
| | - Elizabeth Hegedus
- Department of Pediatrics, Center for Endocrinology, Diabetes, and Metabolism, Children’s Hospital Los Angeles, Los Angeles, CA, United States
| | - Jennifer K. Raymond
- Department of Pediatrics, Center for Endocrinology, Diabetes, and Metabolism, Children’s Hospital Los Angeles, Los Angeles, CA, United States
| | - Michael I. Goran
- Department of Pediatrics, The Saban Research Institute, Children’s Hospital Los Angeles, Los Angeles, CA, United States
| | - Sarah-Jeanne Salvy
- Department of Medicine, Research Center for Health Equity Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, United States
| | - Choo Phei Wee
- Department of Preventive Medicine, Southern California Clinical and Translational Science Institute, Keck School of Medicine, Los Angeles, CA, United States
| | - Ramon Durazo-Arvizu
- Southern California Clinical and Translational Science Institute Biostatistics Core, The Saban Research Institute, Children’s Hospital Los Angeles, Los Angeles, CA, United States
| | - Lilith Moss
- Southern California Clinical and Translational Science Institute Biostatistics Core, The Saban Research Institute, Children’s Hospital Los Angeles, Los Angeles, CA, United States
| | - Alaina P. Vidmar
- Department of Pediatrics, Center for Endocrinology, Diabetes, and Metabolism, Children’s Hospital Los Angeles, Los Angeles, CA, United States
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