Increasing physical activity is recommended as a cornerstone of self-management strategies for diabetes prevention and management. While evidence supporting the effectiveness of various interventions to enhance physical activity in individuals with type 2 diabetes is expanding, there remains a lack of consensus regarding the most effective intervention.

To compare and rank the efficacy of different interventions in improving physical activity among individuals with type 2 diabetes.

Systematic review and network meta-analysis.

PubMed, Cochrane Library, EMBASE, Web of Science, China Knowledge Resource Integrated Database, Wanfang Database, Weipu Database, and Chinese Biomedical Database were systematically searched for relevant studies published from the inception of databases until August 4, 2023. Randomized controlled trials evaluating any interventions aimed at improving physical activity (moderate-to-vigorous physical activity or steps per day measured objectively) in individuals with type 2 diabetes were included. The risk of bias was assessed according to the Revised Cochrane risk-of-bias tool for randomized trials (RoB2). A random-effects network meta-analysis model was employed to synthesize all available evidence. The registration number of this study is CRD42023432185.

33 studies involving 6304 participants were included in the quantitative synthesis. In total, the studies assessed 12 different interventions. Sixteen of the 33 studies (48.5 %) met the adapted Cochrane ROB2 for low risk of bias, while five studies were considered to be at high overall risk of bias. Compared to minimal intervention, multi-component interventions (MD 6.43 min/day, 95 % CI 1.85-11.01) had statistically significant effects on improving moderate-to-vigorous physical activity. Additionally, physical activity programme, counselling plus self-help materials, counselling plus Biofeedback, self-help materials plus biofeedback, physical activity programme plus biofeedback, and multi-component interventions had statistically significant effects on improving daily step counts, with MDs ranging from 1672 to 2504 steps per day in individuals with type 2 diabetes.

A combination of more than two intervention components appears required to increase physical activity. Counselling, physical activity programme, and biofeedback may be effective ingredients of such combinations, especially to increase the daily step count, among individuals with type 2 diabetes. However, the findings should be interpreted cautiously due to the limited number of studies, small sample sizes, and inconsistencies between outcome measures and comparison types. Further research is needed to strengthen the evidence base for clinical decision-making and to identify the most effective intervention combinations.

Flash glucose monitoring (FGM) can improve diabetes management, but no randomised controlled trials (RCTs) of FGM have been undertaken in Indigenous Australian populations. This study aimed to assess the feasibility of performing a RCT of FGM in Indigenous Australians with type 2 diabetes.

In this open-labelled pilot RCT, Indigenous adults with type 2 diabetes were randomised to FGM or standard care for 6 months. Eligible participants were being treated with injectable diabetes medications and had a glycosylated haemoglobin (HbA1c) ≥ 7.0%. The feasibility outcome was the proportion of participants completing the trial, and the primary outcome for the future trial was change in HbA1c from baseline to 6 months. Secondary outcomes included change in time spent in target blood glucose (4.0-10.0 mmol/L), safety (hypoglycaemic episodes), and quality of life (EuroQol 5-dimension 3-level (EQ-5D-3L) score).

Of 126 screened individuals, 74 were eligible, 40 (54%) were randomised, and 39 (97.5%) completed the study. Participants' baseline characteristics were similar between the FGM and usual care groups, except for sex and body mass index. No between-group differences were observed for the following: change in HbA1c; percentage of time spent in target blood glucose (4.0-10.0 mmol/L), low glucose (< 3.9 mmol/L), and high glucose (> 15.0 mmol/L); or EQ-5D-3L scores. No severe hypoglycaemic episodes occurred.

This is the first pilot RCT of FGM in Indigenous Australians with type 2 diabetes. The results support a larger RCT.

Australian New Zealand Clinical Trials Registry (ANZCTR12621000021875), retrospectively registered on 14 January 2021.

A global trend towards increased obesity, intermediate hyperglycemia (previously termed prediabetes) and type 2 diabetes, has prompted a range of international initiatives to proactively raise awareness and provide action-driven recommendations to prevent and manage these linked disease states. One approach, that has shown success in managing people already diagnosed with type 2 diabetes mellitus, is to use continuous glucose monitoring (CGM) devices to help them manage their chronic condition through understanding and treating their daily glucose fluctuations, in assocation with glucose-lowering medications, including insulin. However, much of the burden of type 2 diabetes mellitus is founded in the delayed detection both of type 2 diabetes mellitus itself, and the intermediate hyperglycemia that precedes it. In this review, we provide evidence that using CGM technology in people at-risk of intermediate hyperglycemia or type 2 diabetes mellitus can significantly improve the rate and timing of detection of dysglycemia. Earlier detection allows intervention, including through continued use of CGM to guide changes to diet and lifestyle, that can delay or prevent harmful progression of early dysglycemia. Although further research is needed to fully understand the cost-effectiveness of this intervention in people at-risk or with early dysglycemia, the proposition for use of CGM technology is clear.

Growing evidence suggests the exercise timing, time-of-day it is performed, is important for maximizing glycemic benefits in type 2 diabetes (T2D). This randomized controlled trial investigated the impact of utilizing continuous glucose monitoring to personalise exercise timing on peak hyperglycaemia and cardiometabolic health in people with T2D.

Adults with T2D (HbA1c: 7.2 ± 0.8 %; Age: 63 ± 12 y; BMI: 29 ± 5 kg/m2) were randomized to eight weeks: i) waitlist control (CTL, eight week CTL then re-randomized to interventions), ii) 22-min daily exercise beginning ∼ 30 min before peak hyperglycemia (ExPeak) or iii) 22-min daily exercise ∼ 90 min after peak hyperglycemia (NonPeak). Time of peak hyperglycemia was pre-determined for each participant using the median of a 14-d habitual continuous glucose monitoring (CGM) period. Glycemic control (HbA1c [primary outcome], CGM), vascular function (flow-mediated dilation [FMD]), arterial stiffness, blood pressure) and body composition were assessed. Linear mixed models compared changes across time between groups.

There was no intervention effect for HbA1c, however there was a significant interaction for changes in 24-h peak glucose and %FMD between groups. Compared to CTL, both intervention groups significantly lowered peak glucose (ExPeak: 95 %CI: -2.0 to -0.3 mmol/L, NonPeak: CI: -2.3 to -0.6 mmol/L) and %FMD increased (ExPeak: 95 %CI: 0.6 to 1.5 %, NonPeak: 95 %CI: 0.0 to 1.1 %). Adherence to interventions was high for both intervention groups (>90 %).

Prescribing exercise to target peak hyperglycemia did not improve HbA1c; however cardiometabolic health outcomes improved in both groups prescribed an exercise time compared to control. Personalizing exercise prescription by prescribing a time to exercise may be a novel approach to improve health outcomes and physical activity participation.

Underestimating hyper-/hypoglycemia or failure to perceive hyperglycemia hinders optimal glucose management in diabetes care. Our study investigated individuals who, while aware of their hyper-/hypoglycemia, may not perceive them as problematic. Also, we clarified the factors contributing to discrepancies between these individuals' perceptions and the objective measurements.

This study was a prospective observational study comprising 284 Japanese individuals with type 2 diabetes who underwent ambulatory blinded professional continuous glucose monitoring (CGM) and self-administered the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Individuals with a time above range (TAR; > 180 mg/dL) ≥ 25% and those who answered 0 ("never") or + 1 ("almost never") for the frequency of hyperglycemia in the DTSQ were defined as having no-perception of hyperglycemia. Individuals with a time below range (TBR; < 70 mg/dL) ≥ 4% with an answer of 0 or + 1 for the frequency of hypoglycemia were labeled as having no-perception of hypoglycemia. Multivariate logistic regression analysis was performed to analyze clinical characteristics associated with the discrepancies between failure to perceive hyper-/hypoglycemia and TAR ≥ 25% or TBR ≥ 4%.

Insulin-use (odds ratio [OR] = 0.29, p < 0.05) and older age (OR = 1.05, p < 0.05) were independent determinants of no-perception of hyperglycemia. Low eGFR was an independent determinant of no-perception of hypoglycemia (OR = 0.94, p < 0.05).

No-insulin-use, being an older adult, and renal dysfunction are linked to the discrepancy between the perception of hyper-/hypoglycemia and actual blood glucose. These results will help create personalized diabetes care.

To prospectively examine the ability of some glycemic variability metrics from continuous glucose monitoring (CGM) to predict the development of diabetes in a non-diabetic population.

A total of 497 non-diabetic patients from the AEGIS study were included. Participants used a CGM system (iPro2®) over a six-day period. The following parameters were analyzed: standard deviation (SD), coefficient of variation (CV) and mean amplitude of glucose excursion (MAGE). Six-years follow-up was performed. ROC curves were constructed to determine the predictive value of glycemic variability metrics. Sensitivity and specificity were calculated.

Of the 497 participants, 16 women (4.9 %) and 9 men (5.2 %) developed diabetes. Initial HbA1c and fasting glucose levels were significantly higher in the participants who ultimately developed diabetes. Glycemic variability metrics were also significantly higher in these subjects (SD: 18 vs. 13 mg/dL; CV: 17 vs. 14 %; MAGE: 36 vs. 27 mg/dL; p<0.001 in all cases). SD showed the highest AUC (0.81), with a sensitivity of 80 % and a specificity of 72 % for a cut-off of 14.9 mg/dL. AUCs were higher in men for all metrics.

The metrics obtained by MCG, especially SD, are effective predictors of progression to type 2 diabetes in a non-diabetic population. These findings suggest that glycemic variability is useful for the early identification of subjects at a higher risk of developing diabetes.

Diabetes mellitus represents a major public health challenge worldwide, with type 2 diabetes mellitus (T2DM) accounting for the majority of cases. Urbanization and lifestyle changes are reportedly contributing to the increasing incidence of T2DM worldwide. The prevalence of T2DM is also increasing among women who wish to become pregnant, owing to the growing overall proportion of women with T2DM, the increasing prevalence of obesity, and the rising average age of childbirth. Preconception care is warranted in this demographic to optimize glycemic control, improve pregnancy outcomes, and reduce the risk of congenital anomalies and perinatal complications. Educational support that includes not only glycemic control but also increased physical activity (PA) and lifestyle modifications is important to delivering effective preconception care. Herein, we report the case of a woman in her 30s with T2DM, hypertension, and dyslipidemia. Her early glycemic control was suboptimal (glycated hemoglobin: 8.9%, time in range (TIR): 36.6%), her pregnancy preparation was delayed, and a personalized PA program was eventually introduced that included continuous glucose monitoring (CGM) reviewed by a physical therapist. The intervention lasted four months and included continuous feedback and adjustments to the timing, intensity, and activity goals of the patient's exercise regimen based on her CGM trends. A specific PA target of 8,000-10,000 steps per day was established to promote increased daily movement. The intervention also incorporated a combination of aerobic exercise (walking) and resistance training tailored to the patient's condition and lifestyle. This intervention led to improvements in her blood glucose markers, treatment satisfaction related to diabetes, health-related quality of life, and independence. The patient's TIR increased from 36.6% to 77%, and her PA increased from 2500 to 9500 steps/day. This case study highlights the potential of CGM to promote real-time feedback and behavior modification in patients with T2DM, particularly those attempting pregnancy. PA support combined with CGM can effectively manage blood glucose levels, increase motivation, and improve overall health in ways that are highly beneficial to integrate into preconception care regimens. This study emphasizes that PA support combined with CGM is effective for increasing glycemic control and PA levels, thus improving lifestyle habits and preparing women with T2DM for pregnancy. We advocate for the wider adoption of PA support interventions combined with CGM by physical therapists as a standard practice in preconception care and emphasize the role of this approach in terms of improving long-term metabolic health prior to conception. Further research is warranted to validate these findings and optimize intervention protocols.

Continuous glucose monitoring (CGM) holds potential as a precision public health intervention, offering personalised insights into how diet and physical activity affect glucose levels. Nevertheless, the efficacy of using CGM in populations with and without diabetes to support behaviour change and behaviour-driven outcomes remains unclear. This systematic review and meta-analysis examines whether using CGM-based feedback to support behaviour change affects glycaemic, anthropometric, and behavioural outcomes in adults with and without diabetes.

Ovid MEDLINE, Cochrane Central Register of Controlled Trials, Elsevier Embase, EBSCOhost PsycINFO, and ProQuest Dissertations & Theses Global were searched through January 2024. Eligible studies were randomised controlled trials in adults that implemented CGM-based feedback in at least one study arm compared to a control without CGM feedback. Dual screening, data extraction, and bias assessment were conducted independently. Mean differences in outcomes between intervention and comparison groups were analysed using generic inverse variance models and random effects. Robustness of pooled estimates from random-effects models was considered with sensitivity and subgroup analyses.

Twenty-five clinical trials with 2996 participants were included. Most studies were conducted in adults with type 2 diabetes (n = 17/25; 68%), followed by type 1 diabetes (n = 3/25, 12%), gestational diabetes (n = 3/25, 12%), and obesity (n = 3/25, 12%). Eleven (44%) studies reported CGM-affiliated conflicts of interest. Interventions incorporating CGM-based feedback reduced HbA1c by 0.28% (95% CI 0.15, 0.42, p < 0.001; I2 = 88%), and increased time in range by 7.4% (95% CI 2.0, 12.8, p < 0.008; I2 = 80.5%) compared to arms without CGM, with non-significant effects on time above range, BMI, and weight. Sensitivity analyses showed consistent mean differences in HbA1c across different conditions, and differences between subgroups were non-significant. Only 4/25 studies evaluated the effect of CGM on dietary changes; 5/25 evaluated physical activity.

This evidence synthesis found favourable, though modest, effects of CGM-based feedback on glycaemic control in adults with and without diabetes. Further research is needed to establish the behaviours and behavioural mechanisms driving the observed effects across diverse populations.

CRD42024514135.

Glucagon-like peptide-1 receptor agonist (GLP-1RA) medications have been shown to be effective in achieving optimal glucose control and reducing all-cause death, cardiovascular death, nonfatal myocardial infarction, hospitalization for heart failure, and end-stage kidney disease in individuals with type 1 (T1D) and type 2 diabetes (T2D). However, use of these medications has been associated with increased hypoglycaemia risk in patients treated with concomitant antihyperglycaemic medications. The risk is particularly high in patients with T1D due to their loss of glucagon counter-regulatory response. This article reviews the effect of GLP-1RA formulations on the development of hypoglycaemia in individuals with T1D and T2D treated with insulin therapy, discusses the benefits of continuous glucose monitoring with GLP-1RA treatment, and presents strategies for safely initiating GLP-1RA therapy in these individuals.

Estimate the effectiveness of continuous glucose monitoring (CGM) with remote telemonitoring-enabled virtual diabetes educator visits for improving glycemic management in adults with type 2 diabetes, not on insulin.

Participants with type 2 diabetes, not on insulin, and HbA1c > 7.0 % were enrolled in an open-label randomized trial of 6 weeks of CGM with telemonitoring versus enhanced usual care. Both groups received educator visits. HbA1c was assessed at 12 weeks.

Of 105 participants (mean age 57.3 years, 49.5 % females, mean baseline HbA1c 8.0 %), 86 remained at follow-up. Change in HbA1c was -0.69 % (CGM) versus -0.33 % (enhanced usual care). Adjusting for baseline HbA1c, CGM was superior (0.65 % greater HbA1c reduction [95 % CI 0.17-1.12 %], p = 0.008). CGM participants were 92 % (RR = 1.92, 1.19-3.06, p = 0.007) more likely to have an HbA1c reduction ≥ 0.5 %, lost more weight (difference in weight reduction 2.17 kg, 0.22-4.11, p = 0.029) and were more satisfied with their treatment. No treatment-related adverse events were observed.

CGM with virtual diabetes educator visits is effective, safe, and acceptable in adults with type 2 diabetes not on insulin and should be considered as an alternative to drug therapy for improving blood glucose.

This case study portrays an unusual case of treatment-induced neuropathy of diabetes (TIND) in a patient with uncontrolled type 2 diabetes (T2D) who achieved rapid improvement in glucose control primarily with dietary intervention. Initial presentation was 50-year-old white male with a long-standing history of obesity and a family history of T2D with a screening glucose level >500mg/dL by glucometer, HbA1c of 14.9%, and initial weight 213 lbs.

The initial intervention included a low-carbohydrate diet, metformin, and a continuous glucose monitor (CGM). Semaglutide was added after seven days.

His glycemia was within the target range within three weeks. Four weeks after initiation of therapy, he developed TIND symptoms consisting of burning, tightness, and numbness of bilateral feet along with 10/10 pain. At three months, his HbA1c dropped to 6.9% and his weight to 195 lbs. Treatment of his TIND reduced his pain from 10/10 to 2/10.

Whereas TIND is commonly associated with the use of insulin or sulfonylureas, this study adds evidence to the paucity of literature regarding TIND precipitated by dietary intervention.

Amidst the escalating prevalence of glucose-related chronic diseases, the advancements, potential uses, and growing accessibility of continuous glucose monitors (CGM) have piqued the interest of healthcare providers, consumers, and health behaviour researchers. Yet, there is a paucity of literature characterising the use of CGM in behavioural intervention research. This scoping review aims to describe targeted populations, health behaviours, health-related outcomes, and CGM protocols in randomised controlled trials (RCTs) that employed CGM to support health behaviour change.

We searched Ovid MEDLINE, Elsevier Embase, Cochrane Central Register of Controlled Trials, EBSCOhost PsycINFO, and ProQuest Dissertations & Theses Global from inception to January 2024 for RCTs of behavioural interventions conducted in adults that incorporated CGM-based biological feedback. Citation searching was also performed. The review protocol was registered ( https://doi.org/10.17605/OSF.IO/SJREA ).

Collectively, 5389 citations were obtained from databases and citation searching, 3995 articles were screened, and 31 were deemed eligible and included in the review. Most studies (n = 20/31, 65%) included adults with type 2 diabetes and reported HbA1c as an outcome (n = 29/31, 94%). CGM was most commonly used in interventions to target changes in diet (n = 27/31, 87%) and/or physical activity (n = 16/31, 52%). 42% (n = 13/31) of studies provided prospective CGM-based guidance on diet or activity, while 61% (n = 19/31) included retrospective CGM-based guidance. CGM data was typically unblinded (n = 24/31, 77%) and CGM-based biological feedback was most often provided through the CGM and two-way communication (n = 12/31, 39%). Communication typically occurred in-person (n = 13/31, 42%) once per CGM wear (n = 13/31; 42%).

This scoping review reveals a predominant focus on diabetes in CGM-based interventions, pointing out a research gap in its wider application for behaviour change. Future research should expand the evidence base to support the use of CGM as a behaviour change tool and establish best practices for its implementation.

doi.org/10.17605/OSF.IO/SJREA.

Although continuous glucose monitoring (CGM) devices are now considered the standard of care for people with type 1 diabetes mellitus, the uptake among people with type 2 diabetes mellitus (T2DM) has been slower and is focused on those receiving intensive insulin therapy. However, increasing evidence now supports the inclusion of CGM in the routine care of people with T2DM who are on basal insulin-only regimens or are managed with other medications. Expanding CGM to these groups could minimize hypoglycaemia while allowing efficient adaptation and escalation of therapies. Increasing evidence from randomized controlled trials and observational studies indicates that CGM is of clinical value in people with T2DM on non-intensive treatment regimens. If further studies confirm this finding, CGM could soon become a part of routine care for T2DM. In this Perspective we explore the potential benefits of widening the application of CGM in T2DM, along with the challenges that must be overcome for the evidence-based benefits of this technology to be delivered for all people with T2DM.

The term "prediabetes" has been used to identify the state of abnormal glucose homeostasis (dysglycemia) that often leads to the development of clinical type 2 diabetes. However, this term does not describe the cellular changes that are already taking place in individuals with elevated glucose levels. This article describes our approach to detecting early dysglycemia using continuous glucose monitoring and explains how this approach can be integrated into clinical practice settings.

The aim of this study was to assess the efficacy of continuous glucose monitoring (CGM) versus self-monitoring of blood glucose (SMBG) in maintaining glycaemic control among people with type 2 diabetes mellitus (T2DM).

The protocol was registered in PROSPERO (CRD42023387583). PubMed, Web of Science, EMBASE and OVID databases were searched from 1 January 2000 until 31 December 2022 for randomized controlled trials comparing CGM with SMBG in glycaemic control among the outpatients with T2DM. The primary endpoint was glycated haemoglobin, while the secondary endpoints included time in range, time below range and time above range. Both traditional and network meta-analyses were conducted to explore the efficacy of CGM on glycaemic control in T2DM.

Eleven high-quality studies, involving 1425 individuals with T2DM, were identified. Traditional meta-analysis revealed that CGM exhibited a significantly decreased [mean difference (MD): -0.31, 95% confidence interval (CI) (-0.45, -0.18)], time above range [MD: -9.06%, 95% CI (-16.00, -2.11)], time below range [MD: -0.30%, 95% CI (-0.49, -0.12)] and a significantly increased time in range [MD: 8.49%, 95% CI (3.96, 13.02)] compared with SMBG. The network meta-analysis showed that real-time CGM can improve the glycaemic control of patients with T2DM to the most extent.

CGM could provide T2DM with greater benefits in glycaemic management compared with SMBG, particularly in patients using real-time CGM. These findings provide an updated perspective on previous research and offer guidance for CGM use in T2DM.

The effectiveness of lifestyle interventions in reducing caloric intake and increasing physical activity for preventing Type 2 Diabetes (T2D) has been previously demonstrated. The use of modern technologies can potentially further improve the success of these interventions, promote metabolic health, and prevent T2D at scale. To test this concept, we built a remote program that uses continuous glucose monitoring (CGM) and wearables to make lifestyle recommendations that improve health. We enrolled 2,217 participants with varying degrees of glucose levels (normal range, and prediabetes and T2D ranges), using continuous glucose monitoring (CGM) over 28 days to capture glucose patterns. Participants logged food intake, physical activity, and body weight via a smartphone app that integrated wearables data and provided daily insights, including overlaying glucose patterns with activity and food intake, macronutrient breakdown, glycemic index (GI), glycemic load (GL), and activity measures. The app furthermore provided personalized recommendations based on users' preferences, goals, and observed glycemic patterns. Users could interact with the app for an additional 2 months without CGM. Here we report significant improvements in hyperglycemia, glucose variability, and hypoglycemia, particularly in those who were not diabetic at baseline. Body weight decreased in all groups, especially those who were overweight or obese. Healthy eating habits improved significantly, with reduced daily caloric intake and carbohydrate-to-calorie ratio and increased intake of protein, fiber, and healthy fats relative to calories. These findings suggest that lifestyle recommendations, in addition to behavior logging and CGM data integration within a mobile app, can enhance the metabolic health of both nondiabetic and T2D individuals, leading to healthier lifestyle choices. This technology can be a valuable tool for T2D prevention and treatment.

Type 2 diabetes (T2D) has been rising in prevalence over the past few decades in the US and worldwide. T2D contributes to significant morbidity and premature mortality, primarily due to cardiovascular disease (CVD). Exercise is a major cornerstone of therapy for T2D as a result of its positive effects on glycemic control, blood pressure, weight loss and cardiovascular risk as well as other measures of health. However, studies show that a majority of people with T2D do not exercise regularly. The reasons given as to why exercise goals are not met are varied and include physiological, psychological, social, cultural and environmental barriers to exercise. One potential cause of inactivity in people with T2D is impaired cardiorespiratory fitness, even in the absence of clinically evident complications. The exercise impairment, although present in both sexes, is greater in women than men with T2D. Women with T2D also experience greater perceived exertion with exercise than their counterparts without diabetes. These physiological barriers are in addition to constructed societal barriers including cultural expectations of bearing the burden of childrearing for women and in some cultures, having limited access to exercise because of additional cultural expectations. People at risk for and with diabetes more commonly experience unfavorable social determinants of health (SDOH) than people without diabetes, represented by neighborhood deprivation. Neighborhood deprivation measures lack of resources in an area influencing socioeconomic status including many SDOH such as income, housing conditions, living environment, education and employment. Higher indices of neighborhood deprivation have been associated with increased risk of all-cause, cardiovascular and cancer related mortality. Unfavorable SDOH is also associated with obesity and lower levels of physical activity. Ideally regular physical activity should be incorporated into all communities as part of a productive and healthy lifestyle. One potential solution to improve access to physical activity is designing and building environments with increased walkability, greenspace and safe recreational areas. Other potential solutions include the use of continuous glucose monitors as real-time feedback tools aimed to increase motivation for physical activity, counseling aimed at improving self-efficacy towards exercise and even acquiring a dog to increase walking time. In this narrative review, we aim to examine some traditional and novel barriers to exercise, as well as present evidence on novel interventions or solutions to overcome barriers to increase exercise and physical activity in all people with prediabetes and T2D.

Skin adverse reactions to diabetes medical devices have been reported frequently over recent years. Adhesives attaching glucose sensors and continuous insulin infusion sets to the skin are proven to cause both allergic contact dermatitis and irritant contact dermatitis in patients with diabetes mellitus. Several allergens contained in adhesives and/or parts of medical devices are documented to cause allergic contact dermatitis, with acrylate chemicals being the most common culprit-especially isobornyl acrylate (IBOA), but also 2,2'-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate or cyanoacrylates. Epoxy resin, colophonium and nickel were also identified as causative allergens. However, repetitive occlusion, maceration of the skin and resulting disruption of the skin barrier seem to have an impact on the development of skin lesions as well. The purpose of this study is to highlight the burden of contact dermatitis triggered by diabetes medical devices and to show possible mechanisms responsible for the development of contact dermatitis in a group of diabetic patients.

Application of continuous glucose monitoring (CGM) has moved diabetes care from a reactive to a proactive process, in which a person with diabetes can prevent episodes of hypoglycemia or hyperglycemia, rather than taking action only once low and high glucose are detected. Consequently, CGM devices are now seen as the standard of care for people with type 1 diabetes mellitus (T1DM). Evidence now supports the use of CGM in people with type 2 diabetes mellitus (T2DM) on any treatment regimen, not just for those on insulin therapy. Expanding the application of CGM to include all people with T1DM or T2DM can support effective intensification of therapies to reduce glucose exposure and lower the risk of complications and hospital admissions, which are associated with high healthcare costs. All of this can be achieved while minimizing the risk of hypoglycemia and improving quality of life for people with diabetes. Wider application of CGM can also bring considerable benefits for women with diabetes during pregnancy and their children, as well as providing support for acute care of hospital inpatients who experience the adverse effects of hyperglycemia following admission and surgical procedures, as a consequence of treatment-related insulin resistance or reduced insulin secretion. By tailoring the application of CGM for daily or intermittent use, depending on the patient profile and their needs, one can ensure the cost-effectiveness of CGM in each setting. In this article we discuss the evidence-based benefits of expanding the use of CGM technology to include all people with diabetes, along with a diverse population of people with non-diabetic glycemic dysregulation.

Continuous glucose monitoring (CGM) is beneficial to glycemic control in youth with type 1 diabetes (T1D) and adults with type 2 diabetes (T2D); however, studies in youth with T2D are limited.

Determine if 10-day trial CGM use in youth with T2D improves glycemic control and behavioral modifications.

Youth with T2D > 3 months, on insulin, with no prior CGM use were enrolled. Staff placed CGM and provided education. Participants received 5-day and 10-day follow-up phone calls to review CGM data, behavioral modifications, and adjust insulin doses as needed. We compared 5-day to 10-day TIR, and baseline to 3-6 month HbA1c via paired t-test.

Participants (n=41) had median age of 16.2 y, were 61% female, 81% NH Black, median diabetes duration of 0.8 y, and baseline HbA1c of 10.3%. A majority had household income<$50,000 (81%) and parental education level of HS or less (73%). Average 5-day TIR 49% was similar to 10-day TIR 51% (p=0.62). There was no change in HbA1c after 3-6 months (10.2% v 10.3%, p=0.89). Nineteen participants completed full 10-day CGM use; of those, 84% wanted a CGM long-term. Adolescents reported behavioral changes including increased blood sugar checks, increased insulin administration and overall improved diabetes management.

Although 10-day CGM use did not impact short-term or long-term glycemic control in youth with T2D, most participants reported behavioral changes and wanted to continue using CGM. Future studies with longer use of CGM may clarify the potential impact of CGM in youth with T2D.

Diabetes is a highly prevalent disease associated with considerable cardiovascular end organ damage and mortality. Despite significant changes to the management of acute myocardial infarction over the last two decades, people with diabetes remain at risk of complications and mortality following a myocardial infarct for a multitude of reasons, including increased coronary atherosclerosis, associated coronary microvascular dysfunction, and diabetic cardiomyopathy. Dysglycaemia causes significant endothelial dysfunction and upregulation of inflammation within the vasculature and epigenetic changes mean that these deleterious effects may persist despite subsequent efforts to tighten glycaemic control. Whilst clinical guidelines advocate for the avoidance of both hyper- and hypoglcyaemia in the peri-infarct period, the evidence base is lacking, and currently there is no consensus on the benefits of glycaemic control beyond this period. Glycaemic variability contributes to the glycaemic milieu and may have prognostic importance following myocardial infarct. The use of continuous glucose monitoring means that glucose trends and parameters can now be captured and interrogated, and its use, along with newer medicines, may provide novel opportunities for intervention after myocardial infarction in people with diabetes.

This study examines the potential utility of using continuous glucose monitoring (CGM) to prescribe an exercise time to target peak hyperglycaemia in people with type 2 diabetes (T2D). The main aim is to test the feasibility of prescribing an individualised daily exercise time, based on the time of CGM-derived peak glucose, for people with T2D. Thirty-five individuals with T2D (HbA1c: 7.2 ± 0.8%; age: 64 ± 7 y; BMI: 29.2 ± 5.2 kg/m²) were recruited and randomised to one of two 14 d exercise interventions: i) ExPeak (daily exercise starting 30 min before peak hyperglycaemia) or placebo active control NonPeak (daily exercise starting 90 min after peak hyperglycaemia). The time of peak hyperglycaemia was determined via a two-week baseline CGM. A CGM, accelerometer, and heart rate monitor were worn during the free-living interventions to objectively measure glycaemic control outcomes, moderate-to-vigorous intensity physical activity (MVPA), and exercise adherence for future translation in a clinical trial. Participation in MVPA increased 26% when an exercise time was prescribed compared to habitual baseline (p < 0.01), with no difference between intervention groups (p > 0.26). The total MVPA increased by 10 min/day during the intervention compared to the baseline (baseline: 23 ± 14 min/d vs. intervention: 33 ± 16 min/d, main effect of time p = 0.03, no interaction). The change in peak blood glucose (mmol/L) was similar between the ExPeak (-0.44 ± 1.6 mmol/L, d = 0.21) and the NonPeak (-0.39 ± 1.5 mmol/L, d = 0.16) intervention groups (p = 0.92). Prescribing an exercise time based on CGM may increase daily participation in physical activity in people with type 2 diabetes; however, further studies are needed to test the long-term impact of this approach.

To evaluate the effect on glucose control of professional continuous glucose monitoring (p-CGM)-based care as compared with standard care in the management of patients with type 1 and type 2 diabetes.

The PubMed database was searched comprehensively to identify prospective or retrospective studies evaluating p-CGM as a diagnostic tool for subsequent implementation of lifestyle and/or medication changes and reporting glycated haemoglobin (HbA1c) as an outcome measure.

We found 872 articles, 22 of which were included in the meta-analysis. Overall, the use of p-CGM was associated with greater HbA1c reduction from baseline (-0.28%, 95% confidence interval [CI] -0.36% to -0.21%, I²  = 0%, P < 0.00001) than usual care, irrespective of type of diabetes, length of follow-up, frequency of continuous glucose monitoring (CGM) use and duration of CGM recording. In the few studies describing CGM-derived glucose metrics, p-CGM showed a beneficial effect on change in time in range from baseline (5.59%, 95% CI 0.12 to 11.06, I²  = 0%, P = 0.05) and a neutral effect on change in time below the target range from baseline (-0.11%, 95% CI -1.76% to 1.55%, I²  = 33%, P = 0.90).

In patients with type 1 and type 2 diabetes, p-CGM-driven care is superior to usual care in improving glucose control without increasing hypoglycaemia.

The benefits of real-time continuous glucose monitoring (RT-CGM) are well established for patients with type 1 diabetes (T1D) and patients with insulin-treated type 2 diabetes (T2D). However, the usage and effectiveness of RT-CGM in the context of non-insulin-treated T2D has not been well studied.

We aimed to assess glycemic metrics and rates of RT-CGM feature utilization in users with T1D and non-insulin-treated T2D.

We retrospectively analyzed data from 33,685 US-based users of an RT-CGM system (Dexcom G6; Dexcom, Inc) who self-identified as having either T1D (n=26,706) or T2D and not using insulin (n=6979). Data included glucose concentrations, alarm settings, feature usage, and event logs.

The T1D cohort had lower proportions of glucose values in the 70 mg/dl to 180 mg/dl range than the T2D cohort (52.1% vs 70.8%, respectively), with more values indicating hypoglycemia or hyperglycemia and higher glycemic variability. Discretionary alarms were enabled by a large majority in both cohorts. The data sharing feature was used by 38.7% (10,327/26,706) of those with T1D and 10.4% (727/6979) of those with T2D, and the mean number of followers was higher in the T1D cohort. Large proportions of patients with T1D or T2D enabled and customized their glucose alerts. Retrospective analysis features were used by the majority in both cohorts (T1D: 15,783/26,706, 59.1%; T2D: 3751/6979, 53.8%).

Similar to patients with T1D, patients with non-insulin-treated T2D used RT-CGM system features, suggesting beneficial, routine engagement with data by patients and others involved in their care. Motivated patients with diabetes could benefit from RT-CGM coverage.

Continuous glucose monitoring (CGM) use has several potential positive effects on diabetes management. These benefits are, e.g., increased time in range (TIR), optimized therapy, and developed documentation. Physical activity is a recommended intervention tool in diabetes management, especially for people with type 2 diabetes (T2D). The benefits of physical activity for people with diabetes can be seen as an improvement of glycemic control, glycemic variability, and the reduction of insulin resistance. In relation to the physical activity of people with T2D, the benefits of CGM use can even be increased, and CGM can be a helpful tool to prevent adverse events due to physical activity of people with diabetes, such as hypoglycemic events and nocturnal hypoglycemia after sports. This narrative review aims to provide solid recommendations for the use of CGM in everyday life physical activities based on the noted benefits and to give a general overview of the guidelines on physical activity and CGM use for people with diabetes.

Incorporating physical activity into lifestyle routines is recommended for individuals with type 2 diabetes. Accelerometers offer a promising method for objectively measuring physical activity and for assessing interventions. However, the existing literature for accelerometer-measured physical activity among middle-aged and older adults with type 2 diabetes is lacking.

This study aims to identify research studies in which accelerometer-based cut points were used to classify the physical activity intensity of middle-aged to older adults with type 2 diabetes as sedentary, light, moderate, vigorous, and very vigorous, and to determine if validated accelerometer cut points specifically for this population exist.

We followed the Joanna Briggs Institute methodology for scoping reviews. Between June 23 and July 12, 2020, two reviewers independently screened records from four databases (PubMed, Web of Science, Embase, Engineering Village) and the ActiGraph Corp web site for eligible studies that included patients with type 2 diabetes with a sample mean age ≥50 years, used research-grade accelerometers, applied cut points to categorize objectively measured physical activity, and were available in English. We excluded studies reporting exclusively steps or step counts measured by accelerometers or pedometers and conference abstracts or other sources that did not have a full text available. Data extraction was completed using Microsoft Excel. Data for the following variables were tabulated based on frequency distributions: study design, accelerometer type, device placement, epoch length, total wear time, and cut points used. Study aims and participant demographic data were summarized.

A total of 748 records were screened at the abstract level, and 88 full-text articles were assessed for eligibility. Ultimately, 46 articles were retained and analyzed. Participants' mean ages ranged from 50 to 79.9 years. The ActiGraph accelerometer and the Freedson et al and Troiano et al counts-per-minute cut points were the most frequently used across the literature. Freedson et al and Troiano et al counts-per-minute cut points for light, moderate, and vigorous activity correspond to <1952, 1952-5724, and ≥5725, and 100-2019, 2020-5998, and ≥5999, respectively. The Lopes et al cut points were developed by calibrating the ActiGraph in middle-aged and older adults with overweight/obesity and type 2 diabetes. These counts-per-minute thresholds are ≥200 (light), ≥1240 (moderate), and ≥2400 (vigorous), and were applied in 1 interventional study.

An assortment of accelerometer cut points have been used by researchers to categorize physical activity intensity for middle-aged and older adults with diabetes. Only one set of cut points was validated and calibrated in our population of interest. Additional research is warranted to address the need for diabetes-specific cut points to inform public health recommendations. This includes confirmation that the Lopes et al cut points reflect clinically meaningful changes in physical activity for adults with diabetes who have comorbidities other than overweight/obesity and the development of relative intensity cut points that may be more suitable for those with suboptimal physical functioning.

Little is known about the impact of real-time continuous glucose monitoring (rtCGM) on diabetes-related medical costs within the type 2 diabetes (T2D) population. A retrospective analysis of administrative claims data from the Optum Research Database was conducted. Changes in diabetes-related health care resource utilization costs were expressed as per-patient-per-month (PPPM) costs. A total of 571 T2D patients (90% insulin treated) met study inclusion criteria. Average PPPM for diabetes-related medical costs decreased by -$424 (95% confidence interval [CI] -$816 to -$31, P = 0.035) after initiating rtCGM. These reductions were driven, in part, by reductions in diabetes-related inpatient medical costs: -$358 (95% CI -$706 to -$10, P = 0.044). Inpatient hospital admissions were reduced on average -0.006 PPPM (P = 0.057) and total hospital days were reduced an average of -0.042 PPPM (P = 0.139). These findings provide real-world evidence that rtCGM use was associated with diabetes-related health care resource utilization cost reductions in patients with T2D.

Previous research has identified that people with type 2 diabetes (T2D) within the Hispanic community would benefit from an online peer support community (OPSC) and continuous glucose monitoring (CGM) data to facilitate diabetes self-management.

A mixed-methods feasibility study enrolled Hispanic, Spanish-speaking adults with T2D, not on insulin. Participants were provided with CGM and access to an OPSC for 12 weeks. Feasibility was assessed by number of eligible participants who enrolled, attrition, quantity of CGM data, validated clinical measures of self-efficacy, quality of life and adverse events. Engagement in the OPSC was measured using objective metrics on the online platform. Qualitative interviews were conducted upon conclusion of the intervention to assess feasibility, acceptability, participant satisfaction, and key recommendations for improvement.

Of 46 participants screened, 39 were eligible and 26 completed the study. Participants significantly improved self-efficacy scores. Posts in the OPSC related to goal setting had the highest engagement followed by mid-week and end of week check-in posts respectively. Participant interviews described challenges accessing the OPSC platform as a barrier to engagement. Despite this, all participants were satisfied with the intervention. Key recommendations for improvement included providing greater variety of and individualized education and the use of a peer support platform that is easily accessible.

The CGM + OPSC intervention tailored to the Hispanic community with T2D was feasible, acceptable and satisfactory and improved participant self-efficacy for diabetes management which may lead to improved clinical outcomes.

To determine safety of intranasal insulin (INI) in MemAID trial participants with diabetes treated with systemic insulins.

This randomized, double-blinded trial consisted of 24-week INI or placebo treatment once daily and 24-week follow-up. Safety outcomes were: 1) Short-term effects on glycemic variability, hypoglycemic episodes on continuous glucose monitoring (CGM) at baseline and on-treatment. 2) Long-term effects on glucose metabolism and weight on INI/placebo treatment and post-treatment follow-up. Of 86 screened subjects, 14 were randomized, 9 (5 INI, 4 Placebo) completed CGM at baseline and on-treatment, and 5 (2 INI, 3 Placebo) completed treatment and follow-up.

INI was safe and was not associated with serious adverse events, hypoglycemic episodes or weight gain. INI administration did not acutely affect capillary glucose. Glycemic variability on CGM decreased with INI, compared to baseline. On INI treatment, there was a long-term trend toward lower HbA1c, plasma glucose and insulin. No interactions with subcutaneous insulins were observed.

INI is safe in older people with diabetes treated with systemic insulins, and it is not associated with adverse events, hypoglycemia or weight gain. Future studies are needed to determine whether INI administration can reduce glycemic variability, improve insulin sensitivity and thus potentially lessen diabetes burden in this population.

Approximately 30 million Americans currently suffer from diabetes, and nearly 55 million people will be impacted by 2030. Continuous glucose monitoring (CGM) systems help patients manage their care with real-time data. Although approximately 95% of those with diabetes suffer from type 2, few studies have measured CGM's clinical impact for this segment within an integrated healthcare system.

A parallel randomized, multisite prospective trial was conducted using a new CGM device (Dexcom G6) compared to a standard of care finger stick glucometer (FSG) (Contour Next One). All participants received usual care in primary care clinics for six consecutive months while using these devices. Data were collected via electronic medical records, device outputs, exit surveys, and insurance company (SelectHealth) claims in accordance with institutional review board approval.

Ninety-nine patients were randomized for analysis (n = 50 CGM and n = 49 FSG). CGM patients significantly decreased hemoglobin A1c (p = .001), total visits (p = .009), emergency department encounters (p = .018), and labs ordered (p = .001). Among SelectHealth non-Medicare Advantage patients, per member per month savings were $417 for CGM compared to FSG, but $9 more for Medicare Advantage. Seventy percent of CGM users reported that the technology helped them better understand daily activity and diet compared to only 16% for FSG.

Participants using CGM devices had meaningful improvements in clinical outcomes, costs, and self-reported measures compared to the FSG group. Although a larger study is necessary to confirm these results, CGM devices appear to improve patient outcomes while making treatment more affordable.

To examine the effectiveness of physical activity interventions delivered or prompted by primary care health professionals for increasing moderate to vigorous intensity physical activity (MVPA) in adult patients.

Systematic review and meta-analysis of randomised controlled trials.

Databases (Medline and Medline in progress, Embase, PsycINFO, CINAHL, SPORTDiscus, Sports Medicine and Education Index, ASSIA, PEDro, Bibliomap, Science Citation Index, Conference Proceedings Citation Index), trial registries (Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, TRoPHI), and grey literature (OpenGrey) sources were searched (from inception to September 2020).

Randomised controlled trials of aerobic based physical activity interventions delivered or prompted by health professionals in primary care with a usual care control group or another control group that did not involve physical activity.

Two independent reviewers screened the search results, extracted data from eligible trials and assessed the risk of bias using the Cochrane risk of bias tool (version 2). Inverse variance meta-analyses using random effects models examined the primary outcome of difference between the groups in MVPA (min/week) from baseline to final follow-up. The odds of meeting the guidelines for MVPA at follow-up were also analysed.

14 566 unique reports were identified and 46 randomised controlled trials with a range of follow-ups (3-60 months) were included in the meta-analysis (n=16 198 participants). Physical activity interventions delivered or prompted by health professionals in primary care increased MVPA by 14 min/week (95% confidence interval 4.2 to 24.6, P=0.006). Heterogeneity was substantial (I2=91%, P<0.001). Limiting analyses to trials that used a device to measure physical activity showed no significant group difference in MVPA (mean difference 4.1 min/week, 95% confidence interval -1.7 to 9.9, P=0.17; I2=56%, P=0.008). Trials that used self-report measures showed that intervention participants achieved 24 min/week more MVPA than controls (95% confidence interval 6.3 to 41.8, P=0.008; I2=72%, P<0.001). Additionally, interventions increased the odds of patients meeting guidelines for MVPA by 33% (95% confidence interval 1.17 to 1.50, P<0.001; I2=25%, P=0.11) versus controls. 14 of 46 studies were at high risk of bias but sensitivity analyses excluding these studies did not alter the results.

Physical activity interventions delivered or prompted by health professionals in primary care appear effective at increasing participation in self-reported MVPA. Such interventions should be considered for routine implementation to increase levels of physical activity and improve health outcomes in the population.

PROSPERO CRD42021209484.

This systematic review aims to assess the effects of continuous glucose monitoring (CGM) on maternal and neonatal outcomes in perinatal women with diabetes.

A three-step comprehensive search was conducted based on the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guideline. Randomized controlled trials (RCTs) were retrieved from international databases of PubMed, Embase, Cochrane Library, CINAHL, PsycINFO and Scopus from their respective inception dates until 5th January 2021. Comprehensive Meta-Analysis Software Version 3 was used. The overall effect was determined using Hedges' g. Cochrane collaboration's tool version 1 and grading of recommendations, assessment, development and evaluation criteria were used for quality assessment.

A total of 1215 records were identified and 10 RCTs involving a total of 1358 perinatal women were selected. The meta-analysis revealed that CGM significantly improved HbA1c levels (g = -0.43, 95% CI: -0.63, -0.22), lowered cesarean section rate (g = -0.17, 95% CI: -0.33, -0.02) and neonatal birth weight (g = -0.16, 95% CI: -0.27, -0.04) when compared to the comparator. The majority (86.67%) has a low risk of biases and certainty of evidence ranged from very low to moderate.

CGM improves maternal and neonatal outcomes. Future studies should use well-designed large-scale trials.

Numerous studies have demonstrated the clinical benefits of continuous glucose monitoring (CGM) use in individuals with type 1 diabetes and type 2 diabetes (T2D) who are treated with intensive insulin therapy. A growing body of evidence suggests that CGM use may also confer similar glycemic benefits in T2D individuals who are treated with less-intensive therapies. Investigators are also exploring the potential use of CGM as an aid in weight management. This article reviews the continuing evolution of CGM, focusing on how CGM may be used to improve glycemic control and promote adoption of desired health behaviors within broader T2D and prediabetes populations.

Recent studies have demonstrated the clinical utility of continuous glucose monitoring (CGM) use in type 2 diabetes (T2D) patients who are treated with intensive insulin management. Large retrospective database analyses of T2D patients treated with less-intensive therapies have also shown that CGM use was associated with significant reductions in hemoglobin A1c levels and health resource utilization, including diabetes-related hospitalizations and emergency room care. Despite the growing body of evidence supporting CGM use in the broader T2D population, current eligibility criteria required by public and many private insurers are denying millions of individuals with T2D access to this valuable technology. In this article, we discuss an evidence-based rationale for modifying current eligibility requirements for CGM coverage.

While continuous glucose monitoring (CGM) has been shown to decrease both hyper- and hypoglycemia in insulin-treated diabetes, its value in non-insulin-treated type 2 diabetes (T2D) and prediabetes is unclear. Studies examining the reduction in hyperglycemia with the use of CGM in non-insulin-treated T2D are limited.

We investigated the potential benefit of CGM combined with a mobile app that links each individual's glucose tracing to meal composition, heart rate, and physical activity in a cohort of 1022 individuals, ranging from nondiabetic to non-insulin-treated T2D, spanning a wide range of demographic, geographic, and socioeconomic characteristics. The primary endpoint was the change in time in range (TIR), defined as 54-140 mg/dL for healthy and prediabetes, and 54-180 mg/dL for T2D, from the beginning to end of a 10-day period of use of the Freestyle Libre CGM. Logged food intake, physical activity, continuous glucose, and heart rate data were captured by a smartphone-based app that continuously provided feedback to participants, overlaying daily glucose patterns with activity and food intake, including macronutrient breakdown, glycemic load (GL), and glycemic index (GI).

A total of 665 participants meeting eligibility and data requirements were included in the final analysis. Among self-reported nondiabetic participants, CGM identified glucose excursions in the diabetic range among 15% of healthy and 36% of those with prediabetes. In the group as a whole, TIR improved significantly (p < 0.001). Among the 51.4% of participants who improved, TIR increased by an average of 6.4% (p < 0.001). Of those with poor baseline TIR, defined as TIR below comparable A1c thresholds for T2D and prediabetes, 58.3% of T2D and 91.7% of healthy/prediabetes participants improved their TIR by an average of 22.7% and 23.2%, respectively. Predictors of improved response included no prior diagnosis of T2D and lower BMI.

These results indicate that 10-day use of CGM as a part of multimodal data collection, with synthesis and feedback to participants provided by a mobile health app, can significantly reduce hyperglycemia in non-insulin-treated individuals, including those with early stages of glucose dysregulation.

Increasing physical activity (PA) improves glycemic control in patients with type 2 diabetes mellitus (T2DM). However, whether long-term objectively measured PA is related to glycemic control remains unclear. The aim of this study was to investigate the relationship between long-term objectively measured PA and glycemic control in T2DM patients.

This prospective cohort study recruited T2DM patients admitted to a hospital-based diabetes management and education program. The primary outcome was glycemic control by hemoglobin A1c at 6 months after discharge. We defined poor glycemic control according to the Japanese Clinical Practice Guidelines. The PA was objectively measured using a three-axis accelerometer during 6 months' period after discharge. The representative value of PA was the average daily steps during the measurement period and was divided into quartiles. To determine the relationship between the daily steps and poor glycemic control, we performed a multivariate logistic regression analysis.

Ninety-four participants were enrolled in the study. Their median age was 59 years, and 38 (40.0%) of them showed poor glycemic control. Multivariate logistic regression analysis showed that the first (Q1, ≤ 6106 steps/day) and second quartiles (Q2, 6107-8258 steps/day) had significantly elevated risks of poor glycemic control compared to Q4 (≥ 10,542 steps/day), with odds ratios of 8.55 [95% confidence intervals (CI) =1.43-51.23] and 15.62 (95% CI 2.63-92.87), respectively.

We found that lesser PA was significantly associated with poor glycemic control in T2DM patients. This finding may be beneficial for clinicians while providing long-term advice to diabetic patients.

Diabetes mellitus is a global health concern associated with significant morbidity and mortality. Inadequate control of diabetes leads to chronic complications and higher mortality rates, which emphasizes the importance of achieving glycemic targets. Although glycated hemoglobin (HbA1c) is the gold standard for measuring glycemic control, it has several limitations. Therefore, in recent years, along with the emergence of continuous glucose monitoring (CGM) technology, glycemic control modalities have moved beyond HbA1c. They encompass modern glucometrics, such as glycemic variability (GV) and time-in-range (TIR). The key advantage of these newer metrics over HbA1c is that they allow personalized diabetes management with person-centric glycemic control. Basal insulin analogues, especially second-generation basal insulins with properties such as longer duration of action and low risk of hypoglycemia, have demonstrated clinical benefits by reducing GV and improving TIR. Therefore, for more effective and accurate diabetes management, the development of an integrated approach with second-generation basal insulin and glucometrics involving GV and TIR is the need of the hour. With this objective, a multinational group of endocrinologists and diabetologists reviewed the existing recommendations on TIR, provided their clinical insights into the individualization of TIR targets, and elucidated on the role of the second-generation basal insulin analogues in addressing TIR.

Medical treatment options for type 2 diabetes (T2D) have increased over the last decade and enhance the possibility of individualised treatment strategies where insulin is still one of them. In spite of the advancements in treatment options, less than one-third of the population with T2D obtain their optimal glycaemic goal. In persons with type 1 diabetes, continuous glucose monitoring (CGM) has shown to be the most important driver for improvement in glycaemic control, even more than insulin-pump therapy. The use of technology in T2D has only been investigated in few studies.The overall objective of the research study is to examine the effectiveness of the use of CGM versus self-monitoring of blood glucose (SMBG) in persons with insulin-treated T2D on glycaemic variables and patient-reported outcomes on treatment satisfaction, health behaviour and well-being. The independent effect of peer support will also be studied.

The study is a single centre, prospective, randomised, open-labelled, three-armed study with the randomisation 2:1:2 in group A with CGM, group B with CGM and peer support, and group C as a control group with SMBG. The participants receive a training course unique for the allocation group. The study runs for 12 months and includes 100 adult participants with insulin-treated T2D, treated at the outpatient clinic at Steno Diabetes Center Copenhagen. Primary outcome is difference in change in time in range. Recruitment begins in August 2020 and ends in July 2021. Final 12-month follow-up is anticipated to be in August 2022.

The study will be carried out in accordance with the Helsinki Declaration and is approved by the Scientific Ethics Committee of the Capital Region (H-20000843). Data collection and handling will be performed in accordance with the General Data Protection Regulation and is approved by the Danish Data Protection Agency (J-2020-100). Dissemination will be in international peer-reviewed journals, conferences and a plain-language summary for participants.

ClinicalTrials.gov Registry (NCT04331444).

V.3, 11 December 2020.