Percentage Of Time In Range Research Articles

Efficacy and Safety of Automated Insulin Delivery Systems in Patients with Type 1 Diabetes Mellitus: A Systematic Review and Meta-Analysis.

Automated insulin delivery (AID) systems studies are upsurging, half of which were published in the last 5 years. We aimed to evaluate the efficacy and safety of AID systems in patients with type 1 diabetes mellitus (T1DM). We searched PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov until August 31, 2023. Randomized clinical trials that compared AID systems with other insulin-based treatments in patients with T1DM were considered eligible. Studies characteristics and glycemic metrics was extracted by three researchers independently. Sixty-five trials (3,623 patients) were included. The percentage of time in range (TIR) was 11.74% (95% confidence interval [CI], 9.37 to 14.12; P<0.001) higher with AID systems compared with control treatments. Patients on AID systems had more pronounced improvement of time below range when diabetes duration was more than 20 years (??.80% vs. ??.86%, P=0.031) and baseline glycosylated hemoglobin lower than 7.5% (??.93% vs. ??.87%, P=0.033). Dual-hormone full closed-loop systems revealed a greater improvement in TIR compared with hybrid closed-loop systems (??9.64% vs. ??0.87%). Notably, glycemia risk index (GRI) (??.74; 95% CI, ??.34 to ??.14; P<0.01) was also improved with AID therapy. AID systems showed significant advantages compared to other insulin-based treatments in improving glucose control represented by TIR and GRI in patients with T1DM, with more favorable effect in euglycemia by dual-hormone full closedloop systems as well as less hypoglycemia for patients who are within target for glycemic control and have longer diabetes duration.

Eighteen-Month Hybrid Closed-Loop Use in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Trial.

We aimed to evaluate the longer-term safety and efficacy of hybrid closed-loop (CL) therapy in very young children with type 1 diabetes (T1D). Following a 16-week multinational, randomized crossover trial comparing hybrid CL with sensor-augmented pump (SAP) therapy in 74 very young children aged 1-7 years with T1D, participants were invited to an extension phase using CL for a further 18 months. Outcomes were compared with the primary-phase SAP period and primary-phase CL period. After the primary study phase, 60 participants were eligible to enroll in the extension. Of these, 49 consented (mean ± SD age 6.6 ± 1.5 years) to continue use of CL for 18 months. Percentage time in range (TIR) 3.9-10.0 mmol/L was 8.4 percentage points (95% CI 6.7 to 10.1; P < 0.001) higher, while HbA1c was 0.4% ([5.0 mmol/mol], 95% CI 0.3 to 0.6 [3.7 to 6.2]; P < 0.001) lower during the CL extension phase compared with primary-phase SAP period. At 18 months, mean HbA1c was 6.7 ± 0.5% and TIR was 70 ± 7%, compared with 6.7 ± 0.5% and 71 ± 6% in the primary-phase CL period. Time in hypoglycemia (<3.9 mmol/L) was similar between CL extension phase and both primary-phase SAP (P = 0.31) and CL periods (P = 0.70). There were two severe hypoglycemia events and one other serious adverse event during the extension phase. One unexpected serious adverse device effect occurred. Use of the Cambridge hybrid CL system led to sustained improvements in glycemic control lasting more than 18 months in very young children with T1D.

Glycaemic outcomes in adults with type 2 diabetes over 34 weeks with the Omnipod® 5 automated insulin delivery system.

The aim was to evaluate the effect of extended use of the Omnipod® 5 automated insulin delivery (AID) system in adults with type 2 diabetes and suboptimal glycaemic control. Following an 8-week single-arm, multicentre, outpatient trial of AID in adults with type 2 diabetes and baseline ≥ 64 mmol/mol, participants were given the opportunity to continue use of the AID system in a 26-week (~6 month) extension phase. The primary safety endpoints were percentage of time with sensor glucose ≥ 250 mg/dL and < 54 mg/dL. Additional glycaemic measures, including percentage of time in range (TIR) (70-180 mg/dL) and HbA1c, were evaluated. The use of non-insulin anti-hyperglycaemic medications was permitted throughout the entire study. During the initial 8-week study, participants (N = 22) achieved a decrease in percentage of time ≥ 250 mg/dL from 27.4% ± 21.0% to 10.5% ± 8.8% (p < 0.0001), which further decreased to 9.7% ± 9.2% during the extension phase (p = 0.0002 vs. standard therapy). Percentage of time < 54 mg/dL remained low from standard therapy through extension (median [interquartile range] 0.00% [0.00%, 0.06%] vs. 0.02% [0.00%, 0.05%], p > 0.05). HbA1c decreased by 1.6% ± 1.2% (15.5 ± 13.1 mmol/mol, p < 0.0001) and TIR increased by 22.4% ± 19.2% (p < 0.0001) from standard therapy through extension with no significant change in body mass index and without an observed increase in total daily insulin requirements. These longer-term findings of Omnipod 5 AID system use demonstrate the potential value of AID in helping people with type 2 diabetes reach glycaemic targets.

7437 Harnessing Diabetes Technology for Management of Immune Checkpoint Inhibitor Associated Diabetes

Abstract Disclosure: A. Knape: None. A. Kotwal: None. D. Rohlfsen: None. A. Patel: None. W. Goldner: None. Background: Immune checkpoint inhibitors (ICIs) are a key treatment modality for many cancers. One percent of patients who receive ICIs can develop insulin deficient ICI associated diabetes (ICI-DM). These patients often have complex oncologic therapy plans making treatment of newly diagnosed insulin deficient diabetes challenging which often results in additional healthcare-related burden for the patient. Methods: This is a retrospective case series of five adults who developed ICI-DM after receiving either PD-1, CTLA-4 or PDL-1 inhibitors or a combination. Data on demographics, medical history and labs were collected in addition to mode of glucose monitoring and treatment after diagnosis of ICI-DM. Results: Patients were age 44-72 at diagnosis of ICI-DM, three were female. Two were admitted to the hospital in DKA, one was diagnosed in the ER with severe hyperglycemia without DKA, two had outpatient hyperglycemia without DKA. Glucose at diagnosis ranged from 215-510 mg/dL. C-peptide was low for all patients. Fingerstick blood sugar (FSBS) monitoring and basal/bolus insulin was immediately initiated for all patients. All were transitioned from FSBS to continuous glucose monitor (CGM) and 2/5 ultimately transitioned to sensor-augmented insulin pump therapy (AID). Time in range on CGM improved in four patients with percent time in range improving between 10-48%. In two patients, hypoglycemia frequency declined by 6% and 3%. Hyperglycemia frequency declined by 13% and 48% in patients on AID therapy and by 14% and 25% in two of those on basal/bolus insulin therapy. All patients preferred CGM over FSBS and remained on CGM therapy. Those who chose AID preferred it over basal/bolus insulin therapy stating it was less complicated than basal/bolus insulin with CGM. Conclusions: We report successful treatment of five cases of ICI-DM with CGM + basal/bolus insulin or AID. 80% demonstrated improved time in range and decreased overall frequency of hyperglycemia. 40% had decreased frequency of hypoglycemia. CGM allows for dynamic adjustment of insulin therapy in a population with complex medical regimens resulting in fluctuating glucose levels. The integrated pump and sensor technology in AID was less burdensome than basal/bolus in those who chose it. Managing ICI-DM is complicated. The burden of this entity can be lessened by harnessing the power of diabetes technology. Presentation: 6/2/2024

Nuevas herramientas para el tratamiento de la diabetes tipo 1 en la edad pediátrica

In recent years, new resorces have been appearing in order to improve glycaemic control in patients with type 1 diabetes. These include new insulin analogues, glucose monitoring, smart insulin pens and hybrid close-loop systems. So, in these patients the percentage of time in range has increased, the episodes of hypoglycaemia or hyperglycaemia have decreased, and quality of life has improved. Finally, in the following years biological drugs such as teplizumab will be incorporated, which will be the first etiological treatment for type 1 diabetes.

Closed-Loop Insulin Therapy for People With Type 2 Diabetes Treated With an Insulin Pump: A 12-Week Multicenter, Open-Label Randomized, Controlled, Crossover Trial.

Continuous glucose monitoring (CGM) combined with continuous subcutaneous insulin infusion (CSII) achieves better glycemic control than multi-injection therapy in people with type 2 diabetes. The effectiveness of closed-loop therapy needs to be further evaluated in this population. The study objective was to measure the impact of a hybrid closed-loop device (DBLG1) compared with CSII + CGM on glycemic control in people with type 2 diabetes previously treated with CSII. The randomized, controlled, crossover, two-period, open-label, and multicenter study was conducted from August 2022 to July 2023 in 17 individuals (9 to receive 6 weeks of CSII + CGM first and 8 to receive 6 weeks of closed-loop therapy first). The primary end point was the percentage time in range (TIR: 70-180 mg/dL). Secondary outcomes were other CGM-glucose metrics, physical activity, and sleep objectively measured using 1-week actimetry. Data were analyzed using a modified intention-to-treat approach. Mean age was 63 (SD 9) years and 35% were women. Mean HbA1c at inclusion was 7.9% (SD 0.9). TIR increased to 76.0% (interquartile range 69.0-84.0) during the closed-loop condition vs. 61.0% (interquartile range 55.0-70.0) during the CSII + CGM condition; mean difference was 15.0 percentage points (interquartile range 8.0-22.0; P < 0.001). Analyses of secondary end points showed a decrease in time above range, in glucose management indicator, in glucose variability, and an increase in daily insulin dose. Actimetric sleep analysis showed an improvement in sleep fragmentation during closed-loop treatment. Closed-loop therapy improved glycemic control more than did CSII + CGM in people with type 2 diabetes.

Simple meal announcements and pramlintide delivery versus carbohydrate counting in type 1 diabetes with automated fast-acting insulin aspart delivery: a randomised crossover trial in Montreal, Canada

In type 1 diabetes, carbohydrate counting is the standard of care to determine prandial insulin needs, but it can negatively affect quality of life. We developed a novel insulin-and-pramlintide closed-loop system that replaces carbohydrate counting with simple meal announcements. We performed a randomised crossover trial assessing 14 days of (1) insulin-and-pramlintide closed-loop system with simple meal announcements, (2) insulin-and-placebo closed-loop system with carbohydrate counting, and (3) insulin-and-placebo closed-loop system with simple meal announcements. Participants were recruited at McGill University Health Centre (Montreal, QC, Canada). Eligible participants were adults (aged ≥18 years) and adolescents (aged 12-17 years) with type 1 diabetes for at least 1 year. Participants were randomly assigned in a 1:1:1:1:1:1 ratio to a sequence of the three interventions, with faster insulin aspart used in all interventions. Each intervention was separated by a 14-45-day wash-out period, during which participants reverted to their usual insulin. During simple meal announcement interventions, participants triggered a prandial bolus at mealtimes based on a programmed fixed meal size, whereas during carbohydrate counting interventions, participants manually entered the carbohydrate content of the meal and an algorithm calculated the prandial bolus based on insulin-to-carbohydrate ratio. Two primary comparisons were predefined: the percentage of time in range (glucose 3·9-10·0 mmol/L) with a non-inferiority margin of 6·25% (non-inferiority comparison); and the mean Emotional Burden subscale score of the Diabetes Distress Scale (superiority comparison), comparing the insulin-and-placebo system with carbohydrate counting minus the insulin-and-pramlintide system with simple meal announcements. Analyses were performed on a modified intention-to-treat basis, excluding participants who did not complete all interventions. Serious adverse events were assessed in all participants. This trial is registered on ClinicalTrials.gov, NCT04163874. 32 participants were enrolled between Feb 14, 2020, and Oct 5, 2021; two participants withdrew before study completion. 30 participants were analysed, including 15 adults (nine female, mean age 39·4 years [SD 13·8]) and 15 adolescents (eight female, mean age 15·7 years [1·3]). Non-inferiority of the insulin-and-pramlintide system with simple meal announcements relative to the insulin-and-placebo system with carbohydrate counting was reached (difference -5% [95% CI -9·0 to -0·7], non-inferiority p<0·0001). No statistically significant difference was found in the mean Emotional Burden score between the insulin-and-pramlintide system with simple meal announcements and the insulin-and-placebo system with carbohydrate counting (difference 0·01 [SD 0·82], p=0·93). With the insulin-and-pramlintide system with simple meal announcements, 14 (47%) participants reported mild gastrointestinal symptoms and two (7%) reported moderate symptoms, compared with two (7%) participants reporting mild gastrointestinal symptoms on the insulin-and-placebo system with carbohydrate counting. No serious adverse events occurred. The insulin-and-pramlintide system with simple meal announcements alleviated carbohydrate counting without degrading glucose control, although quality of life as measured by the Emotional Burden score was not improved. Longer and larger studies with this novel approach are warranted. Juvenile Diabetes Research Foundation.

Continuous Glucose Monitoring in Intensive Care Unit Patients with Diabetes: Insights and Outcomes from a Single-center Study in India

Abstract Introduction: The use of continuous glucose monitoring (CGM) for in-hospital glucose control has been widely studied. However, its application in intensive care unit (ICU) settings is debatable owing to its perceived limitations. In ICU patients with diabetes, glycemic excursions, including frequent hypoglycemic episodes, are more prevalent. This retrospective study was undertaken to evaluate the utility of CGM in the management of diabetes patients admitted to the ICU. Methods: We collected data of patients with diabetes mellitus who were admitted to the ICU at our institution and were advised CGM by the intensivist. A retrospective analysis was conducted, examining demographic, clinical, and laboratory data, along with glucose meter readings and CGM data. The results are presented as numbers, percentages, or median values, as appropriate. Results: Out of 65 patients in the ICU, the median values of percentage time in range, time below range, and time above range were 59%, 2%, and 36%, respectively. The median HbA1C and capillary glucose on admission were 8.8% and 246 mg/dl, respectively. During the ICU stay, the CGM derived average glucose level was 167 mg/dl (percent coefficient of variation [%CV] =25.96) and the glucose management indicator was 7%. In total, 65 episodes of hypoglycemia were detected, all confirmed by capillary glucose tests. A total of 27 patients experienced hypoglycemia, of which 12 had nocturnal hypoglycemia. Conclusion: The use of CGM in the ICU improved glycemic control and helped to detect hypoglycemia, particularly nocturnal with acceptably low glycemic variability as measured by percentage CV. Further studies are required to corroborate and confirm these findings.

Long-Term Improvements in Glycemic Control with Dexcom CGM Use in Adults with Noninsulin-Treated Type 2 Diabetes.

Aims: The objective of this real-world, observational study was to evaluate change in continuing glucose monitoring (CGM) metrics for 1 year after CGM initiation in adults with noninsulin-treated type 2 diabetes (T2D). Methods: Data were analyzed from Dexcom G6 and G7 users who self-reported: T2D, ≥18 years, gender, no insulin use, and had a baseline percent time in range (TIR) 70-180 mg/dL of ≤70%. Outcomes were change in CGM metrics from baseline to 6 and 12 months overall and for younger (<65 years) and older (≥65 years) cohorts. Additional analyses explored the relationship between use of the high alert feature and change in TIR and time in tight range (TITR) 70-140 mg/dL. Results: CGM users (n = 3,840) were mean (SD) 52.5 (11.2) years, 47.9% female, mean TIR was 41.7% (21.4%), and 12.4% of participants were ≥65 years. Significant improvement in all CGM metrics not meeting target values at baseline was observed at 6 months, with continued improvement at 12 months. Mean baseline TIR increased by 17.3% (32.1%) from 41.7% (21.4%) to 59.0% (28.9%), and mean glucose management indicator decreased by 0.5% (1.2%) from 8.1% (0.9%) to 7.6% (1.1%) (both P < 0.001). Participants who maintained or customized the high alert default setting of 250 mg/dL had a greater increase in TIR and TITR compared with participants who disabled the alert. Days of CGM use over 12 months were high in 84.7% (15.9%). Conclusion: In this large, real-world study of adults with suboptimally controlled T2D not using insulin, Dexcom CGM use was associated with meaningful improvements in glycemic control over 12 months. Use of the high alert system feature was positively associated with glycemic outcomes. High use of CGM over 12 months suggests benefits related to consistent CGM use in this population.

Real-world glycaemic outcomes of automated insulin delivery in type 1 diabetes: A meta-analysis.

To evaluate the real-world effectiveness of automated insulin delivery (AID) systems in patients with type 1 diabetes (T1D). PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov were searched for studies published up until 2 March 2024. We included pragmatic randomized controlled trials (RCTs), cohort studies, and before-after studies that compared AID systems with conventional insulin therapy in real-world settings and reported continuous glucose monitoring outcomes. Percent time in range (TIR; 3.9-10 mmol/L), time below range (TBR; <3.9 mmol/L), time above range (TAR; >10 mmol/L), and glycated haemoglobin (HbA1c) level were extracted. Data were summarized as mean differences (MDs) with 95% confidence interval. A total of 23 before-after studies (101 704 participants) were included in the meta-analysis. AID systems were associated with an increased percentage of TIR (11.61%, 10.47 to 12.76; p < 0.001). The favourable effect of AID systems was consistently observed when used continuously for 6 (11.76%) or 12 months (11.33%), and in both children (12.16%) and adults (11.04%). AID systems also showed favourable effects on TBR (-0.53%, -0.63 to -0.42), TAR (-9.65%, -10.63 to -8.67) and HbA1c level (-0.42%, -0.47 to -0.37) when compared with previous treatments. Similar improvements in glycaemic parameters were observed in real-world settings in RCTs using AID systems in T1D. AID systems benefit both children and adults by increasing TIR for both short- and long-term interventions.

Real-World Continuous Glucose Monitoring Data from a Population with Type 1 Diabetes in South Korea: Nationwide Single-System Analysis.

Background: We used continuous glucose monitoring (CGM) data to investigate glycemic outcomes in a real-world population with type 1 diabetes (T1D) from South Korea, where the widespread use of CGM and the nationwide education program began almost simultaneously. Methods: Data from Dexcom G6 users with T1D in South Korea were collected between January 2019 and January 2023. Users were included if they provided at least 90 days of glucose data and used CGM at least 70% of the days in the investigational period. The relationship between CGM utilization and glycemic metrics, including the percentage of time in range (TIR), time below range (TBR), and time above range (TAR), was assessed. The study was approved by the Institutional Review Board of Samsung Medical Center (SMC 2023-05-030). Results: A total of 2288 users were included. Mean age was 41.5 years (57% female), with average uploads of 428 days. Mean TIR was 62.4% ± 18.5%, mean TBR <70 mg/dL was 2.6% ± 2.8%, mean TAR >180 mg/dL was 35.0% ± 19.3%, mean glucose was 168.1 ± 35.8 mg/dL, mean glucose management indicator was 7.2% ± 0.9%, and mean coefficient of variation was 36.7% ± 6.0%. Users with higher CGM utilization had higher TIR (67.8% vs. 52.7%), and lower TBR <70 mg/dL (2.3% vs. 4.7%) and TAR >180 mg/dL (30.0% vs. 42.6%) than those with low CGM utilization (P < 0.001 for all). Users whose data were shared with others had higher TIR than those who did not (63.3% vs. 60.8%, P = 0.001). Conclusions: In this South Korean population, higher CGM utilization was associated with a favorably higher mean TIR, which was close to the internationally recommended target. Using its remote data-sharing feature showed beneficial impact on TIR.

Discordance between mean glucose and time in range in relation to HbA1c in individuals with type 1 diabetes: results from the GOLD and SILVER trials

Aims/hypothesisPrevious studies have shown that individuals with similar mean glucose levels (MG) or percentage of time in range (TIR) may have different HbA1c values. The aim of this study was to further elucidate how MG and TIR are associated with HbA1c.MethodsData from the randomised clinical GOLD trial (n=144) and the follow-up SILVER trial (n=98) of adults with type 1 diabetes followed for 2.5 years were analysed. A total of 596 paired HbA1c/continuous glucose monitoring measurements were included. Linear mixed-effects models were used to account for intra-individual correlations in repeated-measures data.ResultsIn the GOLD trial, the mean age of the participants (± SD) was 44±13 years, 63 (44%) were female, and the mean HbA1c (± SD) was 72±9.8 mmol/mol (8.7±0.9%). When correlating MG with HbA1c, MG explained 63% of the variation in HbA1c (r=0.79, p<0.001). The variation in HbA1c explained by MG increased to 88% (r=0.94, p value for improvement of fit <0.001) when accounting for person-to-person variation in the MG–HbA1c relationship. Time below range (TBR; <3.9 mmol/l), time above range (TAR) level 2 (>13.9 mmol/l) and glycaemic variability had little or no effect on the association. For a given MG and TIR, the HbA1c of 10% of individuals deviated by >8 mmol/mol (0.8%) from their estimated HbA1c based on the overall association between MG and TIR with HbA1c. TBR and TAR level 2 significantly influenced the association between TIR and HbA1c. At a given TIR, each 1% increase in TBR was related to a 0.6 mmol/mol lower HbA1c (95% CI 0.4, 0.9; p<0.001), and each 2% increase in TAR level 2 was related to a 0.4 mmol/mol higher HbA1c (95% CI 0.1, 0.6; p=0.003). However, neither TIR, TBR nor TAR level 2 were significantly associated with HbA1c when accounting for MG.Conclusions/interpretationInter-individual variations exist between MG and HbA1c, as well as between TIR and HbA1c, with clinically important deviations in relatively large groups of individuals with type 1 diabetes. These results may provide important information to both healthcare providers and individuals with diabetes in terms of prognosis and when making diabetes management decisions.Graphical

Comparison between a tubeless, on-body automated insulin delivery system and a tubeless, on-body sensor-augmented pump in type 1 diabetes: a multicentre randomised controlled trial.

This study compares the efficacy and safety of a tubeless, on-body automated insulin delivery (AID) system with that of a tubeless, on-body sensor-augmented pump (SAP). This multicentre, parallel-group, RCT was conducted at 13 tertiary medical centres in South Korea. Adults aged 19-69 years with type 1 diabetes who had HbA1c levels of <85.8 mmol/mol (<10.0%) were eligible. The participants were assigned at a 1:1 ratio to receive a tubeless, on-body AID system (intervention group) or a tubeless, on-body SAP (control group) for 12 weeks. Stratified block randomisation was conducted by an independent statistician. Blinding was not possible due to the nature of the intervention. The primary outcome was the percentage of time in range (TIR), blood glucose between 3.9 and 10.0 mmol/l, as measured by continuous glucose monitoring. ANCOVAs were conducted with baseline values and study centres as covariates. A total of 104 participants underwent randomisation, with 53 in the intervention group and 51 in the control group. The mean (±SD) age of the participants was 40±11 years. The mean (±SD) TIR increased from 62.1±17.1% at baseline to 71.5±10.7% over the 12 week trial period in the intervention group and from 64.7±17.0% to 66.9±15.0% in the control group (difference between the adjusted means: 6.5% [95% CI 3.6%, 9.4%], p<0.001). Time below range, time above range, CV and mean glucose levels were also significantly better in the intervention group compared with the control group. HbA1c decreased from 50.9±9.9 mmol/mol (6.8±0.9%) at baseline to 45.9±7.4 mmol/mol (6.4±0.7%) after 12 weeks in the intervention group and from 48.7±9.1 mmol/mol (6.6±0.8%) to 45.7±7.5 mmol/mol (6.3±0.7%) in the control group (difference between the adjusted means: -0.7 mmol/mol [95% CI -2.0, 0.8 mmol/mol] (-0.1% [95% CI -0.2%, 0.1%]), p=0.366). No diabetic ketoacidosis or severe hypoglycaemia events occurred in either group. The use of a tubeless, on-body AID system was safe and associated with superior glycaemic profiles, including TIR, time below range, time above range and CV, than the use of a tubeless, on-body SAP. Clinical Research Information Service (CRIS) KCT0008398 FUNDING: The study was funded by a grant from the Korea Medical Device Development Fund supported by the Ministry of Science and ICT; the Ministry of Trade, Industry and Energy; the Ministry of Health and Welfare; and the Ministry of Food and Drug Safety (grant number: RS-2020-KD000056).

Assessment of Glycemia Risk Index and Standard Continuous Glucose Monitoring Metrics in a Real-World Setting of Exercise in Adults With Type 1 Diabetes: A Post-Hoc Analysis of the Type 1 Diabetes and Exercise Initiative.

Standardized reporting of continuous glucose monitoring (CGM) metrics does not provide extra weighting for very high or very low glucose, despite their distinct clinical significance, and thus may underestimate glycemic risk in people with type 1 diabetes (T1D) during exercise. Glycemia Risk Index (GRI) is a novel composite metric incorporating clinician-validated extra weighting for glycemic extremes, which may provide a novel summary index of glycemia risk around exercise. Adults (≥18 years) in the T1D EXercise Initiative study wore CGM and activity trackers for four weeks. For this analysis, exercise days were defined as 24 hours following ≥20 minutes of exercise, with no other exercise in the 24-hour period. Sedentary days were defined as any 24 hours with no recorded exercise within that period or the preceding 24 hours. Linear mixed-effects regression was used to evaluate exercise effects on GRI and CGM metrics within 24 hours postexercise. In 408 adults with T1D with >70% CGM and activity data, GRI on exercise (N = 3790) versus sedentary days (N = 1865) was significantly lower (mean [SD]: 29.9 [24.0] vs 34.0 [26.1], respectively, absolute mean difference -1.70 [-2.73, -0.67], P < .001), a ~5% reduction in glycemic risk. Percent time in range (TIR; 70-180 mg/dL) increased on exercise days (absolute mean difference 2.67 [1.83, 3.50], P < .001), as did time below range (TBR; relative mean difference 1.17 [1.12, 1.22], P < .001), while time above range (TAR) decreased (relative mean difference 0.84 [0.79, 0.88], P < .001). Glycemia Risk Index improved on exercise versus sedentary days, despite increased TBR, which is weighted most heavily in the GRI calculation, due to a robust reduction in TAR.

Continuous Glucose Monitoring Metrics for Pregnancies Complicated by Diabetes: Critical Appraisal of Current Evidence.

Ascertaining the utility of continuous glucose monitoring (CGM) in pregnancy complicated by diabetes is a rapidly evolving area, as the prevalence of type 1 diabetes (T1D), type 2 diabetes (T2D), and gestational diabetes mellitus (GDM) escalates. The seminal randomized controlled trial (RCT) evaluating CGM use added to standard care in pregnancy in T1D demonstrated significant improvements in maternal glycemia and neonatal health outcomes. Current clinical guidance recommends targets for percentage time in range (TIR), time above range (TAR), and time below range (TBR) during pregnancy complicated by T1D that are widely used in clinical practice. However, the superiority of CGM over blood glucose monitoring (BGM) is still questioned in both T2D and GDM, and whether glucose targets should be different than in T1D is unknown. Questions requiring additional research include which CGM metrics are superior in predicting clinical outcomes, how should pregnancy-specific CGM targets be defined, whether CGM targets should differ according to gestational age, and if CGM metrics during pregnancy should be similar across all types of diabetes. Limiting the potential for CGM to improve pregnancy outcomes may be our inability to maintain TIR > 70% throughout gestation, a goal achieved in the minority of patients studied. Adverse pregnancy outcomes remain high in women with T1D and T2D in pregnancy despite CGM technology, and this review explores the potential reasons and questions yet to be investigated.

Switching from Intermittently Scanned Continuous Glucose Monitoring to Real-Time Continuous Glucose Monitoring with a Predictive Urgent Low Soon Alert Reduces Exposure to Hypoglycemia.

Differences in the effectiveness of real-time continuous glucose monitoring (rtCGM) and intermittently scanned continuous glucose monitoring (isCGM) in type 1 diabetes (T1D) are reported. The impact on percent time in range of switching from an isCGM with glucose threshold-based optional alerts only (FreeStyle Libre 2 [FSL2]) to an rtCGM (Dexcom G7) with an urgent low soon predictive alert was assessed, alongside other secondary outcomes including hemoglobin A1c (HbA1c) and other continuous glucose monitoring metrics. Adults with T1D using FSL2 were switched to Dexcom G7 for 12 weeks. HbA1c and continuous glucose data during FSL2 and Dexcom G7 use were compared. Data from 29 participants (aged 44.8 ± 16.5 years, 12 male and 17 female) were analyzed. After switching to rtCGM, participants spent less time in hypoglycemia below 3.9 mmol/L (70 mg/dL) (3.0% [1.0%, 5.0%] vs. 2.0% [1.0%, 3.0%], P = 0.006) and had higher percentage achievement of time below 3.9 mmol/L (70 mg/dL) of <4% (55.2% vs. 82.8%, P = 0.005). Coefficient of variation was lower (39.3 ± 6.6% vs. 37.2 ± 5.6%, P = 0.008). In conclusion, adults with T1D who switched from isCGM to rtCGM may benefit from reduced exposure to hypoglycemia and glycemic variability.

Early Real-World Performance of the MiniMed™ 780G Advanced Hybrid Closed-Loop System and Recommended Settings Use in the United States.

Background: The MiniMed™ 780G system (MM780G) with Guardian™ 4 sensor includes a 100 mg/dL glucose target (GT) and automated insulin corrections up to every 5 min and was recently approved for use in the United States. In the present study, early real-world MM780G performance and the use of recommended system settings (100 mg/dL GT with an active insulin time of 2 h), by individuals with type 1 diabetes, were evaluated. Methods: CareLink™ personal data uploaded between the launch of the MM780G to August 22, 2023 were aggregated and underwent retrospective analysis (based on user consent) and if users had ≥10 days of continuous glucose monitoring (CGM) data. The 24-h day CGM metrics, including mean glucose, percentage of time spent in (%TIR), above (%TAR), and below (%TBR) target range (70-180 mg/dL), in addition to delivered insulin and closed-loop (CL) exits, were compared between an overall group (n = 7499) and individuals who used recommended settings (each, for >95% of the time). An analysis of the same metrics for MiniMed™ 770G system (MM770G) users (n = 3851) who upgraded to the MM780G was also conducted (paired t-test or Wilcoxon signed-rank test, P < 0.05 considered statistically significant). Results: For MM780G users, CGM use, and time in CL were >90% and all MM780G CGM metrics exceeded consensus-recommended goals. With recommended settings (22% of all users), mean %TIR and %TITR (70-140 mg/dL) were 81.4% and 56.4%, respectively. For individuals who upgraded from the MM770G, %TIR and %TITR increased from 73.2% to 78.3% and 45.8% to 52.6%, respectively, while %TAR reduced from 25.1% to 20.2% (P < 0.001, for all three). CL exits/week averaged <1, for all MM780G users. Conclusions: Early real-world MM780G use in the United States demonstrated a high percentage of time in range with low time above and below range. These outcomes are similar to those observed for real-world MM780G use in other countries.

Continuous Glucose Monitoring Profiles and Health Outcomes after Dapagliflozin Plus Saxagliptin vs Insulin Glargine.

Glycemic variability and hypoglycemia during diabetes treatment may impact therapeutic effectiveness and safety, even when glycated hemoglobin (HbA1c) reduction is comparable between therapies. We employed masked continuous glucose monitoring (CGM) during a randomized trial of dapagliflozin plus saxagliptin (DAPA+SAXA) vs insulin glargine (INS) to compare glucose variability and patient-reported outcomes (PROs). 24-week sub-study of a randomized, open-label, two-arm, parallel-group, phase 3b study. Multicenter study (112 centers in 11 countries). 283 adults with type 2 diabetes (T2D) inadequately controlled with metformin ± sulfonylurea. DAPA+SAXA vs INS. Changes in CGM profiles, HbA1c, and PROs. Changes from baseline in HbA1c with DAPA+SAXA were similar to those observed with INS, with mean difference [95% CI] between decreases of -0.12% [-0.37 to 0.12%], P = .33. CGM analytics were more favorable for DAPA+SAXA, including greater percent time in range (> 3.9 and ≤ 10 mmol/L; 34.3 ± 1.9 vs 28.5 ± 1.9%, P = .033), lower percent time with nocturnal hypoglycemia (area under the curve ≤ 3.9 mmol/L; 0.6 ± 0.5 vs 2.7 ± 0.5%, P = .007), and smaller mean amplitude of glycemic excursions (-0.7 ± 0.1 vs -0.3 ± 0.1 mmol/L, P = .017). Improvements in CGM were associated with greater satisfaction, better body weight image, less weight interference, and improved mental and emotional well-being. DAPA+SAXA and INS were equally effective in reducing HbA1c at 24 weeks, but people with T2D treated with DAPA+SAXA achieved greater time in range, greater reductions in glycemic excursions and variability, less time with hypoglycemia, and improved patient-reported health outcomes.

Real-World Evidence of Omnipod® 5 Automated Insulin Delivery System Use in 69,902 People with Type 1 Diabetes.

Background: The Omnipod® 5 Automated Insulin Delivery System was associated with favorable glycemic outcomes for people with type 1 diabetes (T1D) in two pivotal clinical trials. Real-world evidence is needed to explore effectiveness in nonstudy conditions. Methods: A retrospective analysis of the United States Omnipod 5 System users (aged ≥2 years) with T1D and sufficient data (≥90 days of data; ≥75% of days with ≥220 continuous glucose monitor readings/day) available in Insulet Corporation's device and person-reported datasets as of July 2023 was performed. Target glucose setting usage (i.e., 110-150 mg/dL in 10 mg/dL increments) was summarized and glycemic outcomes were examined. Subgroup analyses of those using the lowest average glucose target (110 mg/dL) and stratification by baseline characteristics (e.g., age, prior therapy, health insurance coverage) were conducted. Results: In total, 69,902 users were included. Multiple and higher glucose targets were more commonly used in younger age groups. Median percentage of time in range (TIR; 70-180 mg/dL) was 68.8%, 61.3%, and 53.6% for users with average glucose targets of 110, 120, and 130-150 mg/dL, respectively, with minimal time <70 mg/dL (all median <1.13%). Among those with an average glucose target of 110 mg/dL (n = 37,640), median TIR was 65.0% in children and adolescents (2-17 years) and 69.9% in adults (≥18 years). Subgroup analyses of users transitioning from Omnipod DASH or multiple daily injections and of Medicaid/Medicare users demonstrated favorable glycemic outcomes among these groups. Conclusion: These glycemic outcomes from a large and diverse sample of nearly 70,000 children and adults demonstrate effective use of the Omnipod 5 System under real-world conditions.

Impact of a Mediterranean diet, physical activity, body composition, and insulin delivery methods on metabolic control in children with type 1 diabetes.

To evaluate the synergistic impact of diet, lifestyle and technology on glycemic control in children with type 1 diabetes (T1D). This cross-sectional study included 112 randomly selected patients with T1D from Gran Canaria (median age 12 years; 51.8% female). The study collected data on height, weight, body composition (bioimpedance), age, disease duration, and method of insulin delivery. Physical activity was evaluated using the Krece questionnaire and an accelerometer (GENEActiv). Adherence to the Mediterranean diet was assessed using the KIDMED Quick Nutrition Test. Glycemic control was evaluated using HbA1c and the percentage of time in range. SPSS version 21 and RStudio were used for statistical analysis of the data. Stepwise linear regression analysis (backwards) was used to identify factors independently associated with metabolic control. Insulin pump use, age and adherence to the Mediterranean diet were found to be significantly and independently associated with better glycemic control, whereas years with T1D was associated with worse HbA1c values. No relationship was found between body composition and physical activity measured by accelerometry or questionnaire. Adherence to the Mediterranean diet, insulin delivery methods, age, and number of years with T1D are important factors to consider in the management of T1D in children.