Diabetes technology & therapeutics最新文献

{"title":"Continuous Glucose Monitoring in Type 1 Diabetes, Type 2 Diabetes, and Diabetes During Pregnancy: A Systematic Review with Meta-Analysis of Randomized Controlled Trials.","authors":"Evangelos C Rizos, Georgios Markozannes, Nikolaos Charitakis, Panagiotis Filis, Anastasia E Stoimeni, Kirsten Nørgaard, Evangelia E Ntzani, Konstantinos K Tsilidis","doi":"10.1089/dia.2024.0599","DOIUrl":"10.1089/dia.2024.0599","url":null,"abstract":"<p><p><b><i>Background:</i></b> Continuous glucose monitoring (real-time CGM [RT-CGM] and retrospective [professional] CGM [non-RT-CGM]) is an emerging tool to assess glucose levels and variability. We performed a meta-analysis of randomized controlled trials (RCTs) to assess the effect of RT/non-RT-CGM on type 1 (T1D), type 2 (T2D), and diabetes in pregnancy (DiP) compared with self-monitoring of blood glucose (BGM). <b><i>Methods:</i></b> We searched PubMed/EMBASE/Cochrane Central Register of Controlled Trials until October 2024. The coprimary outcomes were the weighted mean change differences (WMCDs and absolute differences) from baseline in glycated hemoglobin (HbA1c) and in time in range (TIR%), time below range (TBR%), and time above range (TAR%). <b><i>Results:</i></b> A total of 64 RCTs were analyzed: (1) RT-CGM/T1D: CGM was superior to BGM for HbA1c reduction (WMCD -0.24, 95% confidence interval [CI]: -0.35; -0.14, <i>I</i>²= 71%), decrease in TBR <70 mg/dL (WMCD -2.41, 95% CI: -3.46; -1.35, <i>I</i>²= 96%), decrease in TBR < 54 mg/dL (WMCD -1.18 95% CI: -1.9; -0.47, <i>I</i>²= 97%), decrease in TAR >180 mg/dL (WMCD -2.99, 95% CI: -5.28; -0.71, <i>I</i>² = 92%), decrease in TAR >250 mg/dL (WMCD -3.99, 95% CI: -5.76; -2.21, <i>I</i>²= 92%), and increase in TIR 70-180 mg/dL (WMCD 5.57, 95% CI: 4.13; 7.01, <i>I</i>²= 84%); (2) RT-CGM/T2D: CGM was superior to BGM for HbA1c reduction (WMCD -0.40, 95% CI: -0.55; -0.24, <i>I</i>²= 52%), decrease in TAR > 180 mg/dL (WMCD -6.32, 95% CI: -9.87; -2.78, <i>I</i>²= 84%), decrease in TAR > 250 mg/dL (WMCD -5.73, 95% CI: -8.96; -2.49, <i>I</i>²= 89%), and increase in TIR 70-180 mg/dL (WMCD 5.46, 95% CI: 2.76; 8.16, <i>I</i>²= 69%); (3) RT-CGM/DiP: CGM was superior to BGM for TIR 63-140 mg/dL (WMCD: 17.77, 95% CI: 4.17; 31.36, <i>I</i>²= 92%). No benefit was shown for HbA1c, TBR < 63 mg/dL, TAR > 140 mg/dL, and most of the maternal and neonatal outcomes of interest; (4) Non-RT CGM: HbA1c significantly decreased with non-RT CGM compared with BGM in T2D (WMCD -0.35, 95% CI: -0.5; -0.2, <i>I</i>²= 19%). <b><i>Discussion:</i></b> In T1D and T2D, RT-CGM decreased HbA1c and increased time in target range for glycemia (70-180 mg/dL) while decreasing time spent in hypoglycemia (T1D) and time in hyperglycemia (T1D, T2D).</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"537-552"},"PeriodicalIF":5.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143572423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Role of a Continuous Glucose Monitoring-Derived Glycation Ratio in the Development of Microvascular Complications.","authors":"Laura B Bovee, Theodore A Gooley, Jordan E Perlman, Irl B Hirsch","doi":"10.1089/dia.2024.0580","DOIUrl":"10.1089/dia.2024.0580","url":null,"abstract":"<p><p><b><i>Background:</i></b> Previous studies have evaluated the associations between HbA1c discordance and diabetes complications using indices of glycation. The ideal index would allow for identification of those at increased risk for microvascular complications. This analysis evaluates the association of a newly published index, the glycation ratio (GR), with diabetic retinopathy (DR) and diabetic kidney disease (DKD). <b><i>Methods:</i></b> This is a retrospective review of 661 patients with diabetes seen at the University of Washington. All patients used continuous glucose monitoring (CGM) before the study. Diabetes duration was greater than 20 years in 59%. Median age was 45 years. GR was defined as the ratio of the glucose management indicator (GMI) to the HbA1c. The associations of GR with microvascular complications were each assessed using logistic regression. <b><i>Results:</i></b> Modeling GR as a continuous linear variable, each increase in GR of 0.20 units was associated with a 38% relative reduction in the odds of DR (adjusted odds ratio [OR] = 0.62; 95% confidence interval [CI]: 0.45-0.86, <i>P</i> = 0.004] and a similar reduction in the odds of DKD (OR = 0.61; 95% CI: 0.41-0.93, <i>P</i> = 0.02). <b><i>Conclusions:</i></b> GR may be a useful marker for risk of diabetic microvascular complications. Longitudinal assessment will be required to see how well GR compares with GMI or HbA1c alone.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"553-557"},"PeriodicalIF":5.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Association of Time-in-Range and Time-in-Tight-Range with Retinopathy Progression in the Virtual Diabetes Control and Complications Trial Continuous Glucose Monitoring Dataset.","authors":"Benjamin Lobo, Lauren Kanapka, Boris P Kovatchev, Craig Kollman, Roy W Beck","doi":"10.1089/dia.2025.0033","DOIUrl":"10.1089/dia.2025.0033","url":null,"abstract":"<p><p><b><i>Background:</i></b> In a prior work, a virtual continuous glucose monitoring (CGM) trace was generated for each of the 1441 participants in the landmark Diabetes Control and Complications trial (DCCT). These new data allow us to compare whether time-in-tight-range (TITR) is a better predictor of diabetic microvascular complications (specifically retinopathy development or progression) than time-in-range (TIR). <b><i>Methods:</i></b> Discrete Cox proportional hazard models were used to calculate the hazard ratios (HRs) for the development/progression of retinopathy. <b><i>Results:</i></b> For a 1.0 standard deviation (SD) change, the adjusted HR (95% confidence interval) was 2.67 (2.33-3.06) for TIR, 2.74 (2.36-3.18) for TITR, and 2.37 (2.13-2.65) for HbA1c; a similar pattern of results was obtained for a 0.5 SD change. Computing Harrell's C-statistic showed that a survival model adjusted for TIR, TITR, or HbA1c had similar predictive performance. <b><i>Conclusion:</i></b> The associations of TIR and TITR with retinopathy development or progression were similar to HbA1c in the virtual DCCT CGM dataset.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"558-561"},"PeriodicalIF":5.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Meal Insulin Bolus Timing and Bedtime Snacking on Continuous Glucose Monitoring-Derived Glycemic Metrics in Hospitalized Inpatients.","authors":"Sara M Alexanian, Michael C Cheney, Jenny C Bello Ramos, Nicole L Spartano, Howard A Wolpert, Devin W Steenkamp","doi":"10.1089/dia.2025.0027","DOIUrl":"10.1089/dia.2025.0027","url":null,"abstract":"<p><p><b><i>Objective:</i></b> In hospitalized inpatients, timely administration of prandial insulin with meals is challenging. Furthermore, the glycemic impact of snacking after dinner (\"bedtime snacking\") without prandial insulin administration has not been previously explored. We present an analysis of the impact of delayed mealtime insulin administration and bedtime snacking on inpatient glycemic control. <b><i>Research Design and Methods:</i></b> We conducted a post hoc analysis from the In-Fi study: a randomized controlled trial comparing Fiasp versus insulin aspart (Novolog) in inpatients with type 2 diabetes. Glycemic outcomes were assessed using the Dexcom G6 PRO continuous glucose monitoring (CGM). We analyzed CGM and insulin administration data from 122 randomized subjects who completed the primary study protocol, which included wearing a CGM for ≥4 meals. This analysis evaluates the impact of delayed mealtime insulin administration and bedtime snacking on glucose control. <b><i>Results:</i></b> Four-hour postprandial time in range (TIR_70-180) was 48% for insulin boluses administered before meals (<i>n</i> = 149) versus 24% when a meal bolus was delayed for >5 min after a meal (mean delay 58.7 min; <i>n</i> = 112; <i>P</i> < 0.001). Bedtime snacking (9 pm-12 am) was associated with significantly higher fasting glucose the next morning (35.2 mg/dL, standard error [SE] = 15.4, <i>P</i> = 0.026) and with a reduced overnight (9 pm-6 am) TIR_70-180 (31.9%, SE = 8.06, <i>P</i> < 0.001), adjusting for bedtime sensor glucose. Bedtime snacking was associated with higher overnight glucose standard deviation (12.3 mg/dL, SE = 3.46, <i>P</i> < 0.001) and with higher overnight glucose percentage coefficient of variation (3.6%; SE = 1.7, <i>P</i> = 0.044), adjusting for initial bedtime sensor glucose. <b><i>Conclusions:</i></b> Delayed mealtime insulin administration and bedtime snacking without insulin administration are significant causes of postprandial and overnight hyperglycemia in hospitalized inpatients. Adjustments in mealtime insulin protocols, attention to food intake, and the potential inpatient adoption of technology, such as CGM and automated insulin delivery systems, are needed to address this shortcoming in inpatient diabetes care.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"511-516"},"PeriodicalIF":5.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604173","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Automated Insulin Delivery in Elderly with Type 1 Diabetes: A Prespecified Analysis of the Extension Phase.","authors":"Yogish C Kudva, Robert J Henderson, Lauren G Kanapka, Ruth S Weinstock, Michael R Rickels, Richard E Pratley, Naomi Chaytor, Kamille Janess, Donna Desjardins, Vishwanath Pattan, Amy J Peleckis, Anna Casu, Shafaq Raza Rizvi, Suzan Bzdick, Keri J Whitaker, Jorge L Jo Kamimoto, Kellee Miller, Craig Kollman, Roy W Beck","doi":"10.1089/dia.2024.0560","DOIUrl":"10.1089/dia.2024.0560","url":null,"abstract":"<p><p>The Automated Insulin Delivery in Elderly with Type 1 Diabetes (AIDE T1D) trial randomized 82 adults ≥65 years with type 1 diabetes (T1D) to hybrid closed loop (HCL), predictive low glucose suspend (PLGS), and sensor-augmented pump (SAP) therapy in a randomized crossover trial. Seventy-five of the 78 completers joined an extension phase in which they were offered the pump mode of their choice for an additional 3 months. Mean age was 71 ± 4 years (range 65-86 years) and mean duration of T1D was 42 ± 17 years (range 1-68 years). Use of HCL was selected by 91%, PLGS by 8%, and continuous glucose monitoring with injections by 1%. For participants selecting HCL, time-in-range 70-180 mg/dL was similar in the randomized controlled trial and extension phase (mean 75% ± 10%). One severe hypoglycemic event was reported. HCL was preferred over PLGS or SAP and remained effective in older adults with T1D. Clinical Trial Registration: NCT04016662.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"572-575"},"PeriodicalIF":5.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604166","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correlation Between A1c and Continuous Glucose Monitor Time in Range in a Cohort of Pediatric Patients with Type 1 Diabetes.","authors":"Marisa Sobczak, Laura Pyle, Alexandra Sawyer, Gregory P Forlenza, G Todd Alonso","doi":"10.1089/dia.2024.0500","DOIUrl":"10.1089/dia.2024.0500","url":null,"abstract":"<p><p>Hemoglobin A1c (A1c) is the standard for glycemic control in type 1 diabetes. With recent increase in continuous glucose monitoring (CGM), other metrics (time in range 70-180 mg/dL [TIR]) are increasingly available. Data are limited for youth. We evaluated the association between A1c and time in range in a large pediatric cohort. We included patients from 2018 through 2020, aged <22 years with ≥70% CGM usage (<i>n</i> = 2393). A linear correlation between A1c and TIR was observed (correlation coefficient -0.73), similar to studies in adults. Each 1% increase in A1c was associated with a 9.1% lower TIR. The <i>R</i>² for A1c versus mean sensor glucose was 0.66 (<i>P</i> < 0.001) and A1c versus TIR was 0.55 (<i>P</i> < 0.001). TIR correlates with A1c in children with type 1 diabetes. TIR should be considered alongside A1c. Further research is warranted to establish long-term outcomes associated with TIR in children.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"567-571"},"PeriodicalIF":5.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143398832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Continuous Glucose Monitoring-Based Titration of Once-Weekly Insulin Icodec in Insulin-Naive Individuals with Type 2 Diabetes (ONWARDS 9): A Phase 3b, Multicenter, Single-Arm, Treat-to-Target Clinical Trial.","authors":"Richard M Bergenstal, Björg Ásbjörnsdóttir, Tanvir Johanning Bari, Satish Hulkund, Yvonne Winhofer, Carol Wysham","doi":"10.1089/dia.2025.0050","DOIUrl":"10.1089/dia.2025.0050","url":null,"abstract":"<p><p><b><i>Background:</i></b> ONWARDS 9 explored, for the first time, the effect of continuous glucose monitoring (CGM)-based titration of once-weekly insulin icodec (icodec) on glycemic control and safety outcomes in individuals with type 2 diabetes (T2D). <b><i>Methods:</i></b> In this 26-week, multicenter, single-arm, treat-to-target, phase 3b trial, insulin-naive adults with T2D (glycated hemoglobin [HbA1c] 7.0%-11.0%) initiated icodec at a starting dose of 70 U/week. Participants were provided with an intermittently scanned CGM device, and icodec doses were titrated weekly based on pre-breakfast CGM values (target: 80-130 mg/dL). The primary endpoint was change in HbA1c from week 0 to week 26. Exploratory endpoints included the percentage of time in range (TIR; 70-180 mg/dL), time above range (TAR; >180 mg/dL), and time below range (TBR; <54 mg/dL) from week 22 to week 26. Safety outcomes, including the number of hypoglycemia episodes, were assessed. <b><i>Results:</i></b> Of 58 participants screened, 51 received icodec treatment. HbA1c decreased from an observed mean of 8.18% at week 0 to an estimated mean of 7.00% at week 26. There was a statistically significant reduction in HbA1c of -1.17%-points (95% confidence interval: -1.36; -0.99, <i>P</i> < 0.0001). From week -2 to 0 to week 22-26, a concomitant clinically meaningful increase in TIR (54.4% to 76.4%) and decrease in TAR (45.2% to 22.9%) was observed; TBR remained low throughout the trial (week -2 to 0: 0.03%; week 22-26: 0.04%). No severe hypoglycemic episodes were reported during the trial, and no new safety concerns for icodec were identified. <b><i>Conclusion:</i></b> After 26 weeks of treatment with icodec titrated based on CGM data, there was a statistically significant reduction in HbA1c from baseline, and the internationally recommended CGM targets for TIR, TAR >180 mg/dL, and TBR <54 mg/dL were achieved. These findings suggest that CGM-based titration of icodec is a feasible method for initiating insulin therapy in T2D. <b><i>Trial registration:</i></b> ClinicalTrials.gov identifiers: NCT05823948.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"527-536"},"PeriodicalIF":5.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Omnipod5 Real-World Data from the First Pediatric Users' Universal Coverage Under the UK National Health Service.","authors":"Sze May Ng, Zoe Tattersall, Violet Swain, Katherine Quirk, Gursagar Sandhu, Astha Soni","doi":"10.1089/dia.2024.0666","DOIUrl":"10.1089/dia.2024.0666","url":null,"abstract":"<p><p><b><i>Background:</i></b> Hybrid closed-loop (HCL) systems combine continuous glucose monitoring (CGM) with insulin pumps to automate insulin delivery through specific algorithms and user input. This real-world study aimed to evaluate the effectiveness of the Omnipod5 HCL system on HbA1c, time-in-range (TIR), hypoglycemia frequency, and sensor glucose variability over 3 and 6 months in children and young people with type 1 diabetes at two National Health Service (NHS)-funded pediatric diabetes centers in North West England. <b><i>Methods:</i></b> Children younger than 18 years in two teaching hospital-based diabetes centers were started on Omnipod5 between August 2023 and January 2024. Sensor glucose metrics and HbA1c were collected within 3 months before Omnipod5 initiation and compared at 3 and 6 months postinitiation. Metrics included % TIR (sensor glucose 70-180 mg/dL), % time above range (TAR) (sensor glucose >180 mg/dL and >250 mg/dL), and % time below range (TBR) (sensor glucose <70 mg/dL mmol/L and <54 mg/dL), with variability assessed by coefficient of variation (CV) and standard deviation (SD). <b><i>Results:</i></b> A total of 144 children were included, with 46% males and a mean age of 7.1 years (SD 4.3). The cohort was predominantly White (80%), with diabetes duration averaging 4.4 years (SD 3.9). Before Omnipod5, 54% used multiple daily injections, 41% a nonintegrated pump, and 5% another HCL system. At 3 and 6 months postinitiation, there were significant improvements in HbA1c from 7.7% (60.2 mmol/mol) to 7.1% (54.4 mmol/mol) at 3 months and 7.2% (55.2 mmol/mol) at 6 months. TIR improved from 53.3% at baseline to 67.4% at 3 months and 68.8% at 6 months), and reductions in TAR, TBR, and CV were also observed. <b><i>Conclusions:</i></b> These findings highlight the Omnipod5 system's safety and effectiveness in improving glycemic control for children and young people (CYP) with type 1 diabetes in a real-world NHS setting. Further research is needed to explore the long-term benefits and cost-effectiveness of this tubeless HCL system in routine clinical care.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"562-566"},"PeriodicalIF":5.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Once-Weekly Insulins.","authors":"J Hans DeVries, Tim Heise","doi":"10.1089/dia.2024.0653","DOIUrl":"10.1089/dia.2024.0653","url":null,"abstract":"<p><p>One hundred years after insulin became commercially available, new formulations are still being developed. A first once-weekly insulin has been introduced on various markets, and results of the registration studies of a second once-weekly insulin are becoming available. In this narrative review, we discuss the mechanisms of prolongation, early clinical research study results, and the registration studies of these insulins, with a critical appraisal.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"503-510"},"PeriodicalIF":5.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Open-Source Versus Commercial Automated Insulin Delivery System for Type 1 Diabetes Management: A Prospective Observational Comparative Study from Canada.","authors":"Zekai Wu, Maha Lebbar, Anne Bonhoure, Marie Raffray, Marie Devaux, Caroline Grou, Virginie Messier, Valérie Boudreau, Andréanne Vanasse, Anne-Sophie Brazeau, Rémi Rabasa-Lhoret","doi":"10.1089/dia.2024.0561","DOIUrl":"10.1089/dia.2024.0561","url":null,"abstract":"<p><p><b><i>Objective:</i></b> This study compares unregulated open-source (OS) automated insulin delivery (AID) systems and commercial-AID (C-AID) systems regarding glucose management, patient-reported outcomes (PROs), and safety among adults with type 1 diabetes (T1D). <b><i>Methods:</i></b> We conducted a 12-week, prospective, observational, noninferiority, comparative, real-world study involving 78 adults with T1D and having used an AID system for ≥3 months (26 OS-AID and 52 C-AID users). A total of 4-week data from a blinded continuous glucose monitor was used to assess the effectiveness in glucose management (primary outcome: 24 h time in range [TIR%] for 4 weeks, with a noninferiority margin of 5%). <b><i>Results:</i></b> Our study suggested that OS-AIDs were noninferior to C-AIDs regarding the 24 h TIR% (78.3% [standard deviation or SD 11.0] vs. 71.2% [SD 10.9], mean difference 7.2% [95.08% confidence interval or CI: 1.9% to 12.5%], <i>P</i> < 0.001), even after adjusting for various confounding factors. OS-AIDs spent more time in hypoglycemia (<3.9 mmol/L) than C-AIDs (3.9% [SD 3.1] vs. 1.8% [SD 1.3], <i>P</i> < 0.001) yet within the recommended range. OS-AID users reported less fear of hypoglycemia, while other PRO measures (diabetes distress, hypoglycemia awareness, sleep, fear of hypoglycemia, treatment satisfaction, and overall quality of life) were not different between groups. No severe hypoglycemia or diabetic ketoacidosis was reported in either group, with a similar occurrence rate of technical issues during the 12-week study period. <b><i>Conclusions:</i></b> OS-AIDs are safe and noninferior to C-AIDs for TIR% among adults with T1D in real-world settings. Both OS-AID and C-AID systems can be considered for T1D management.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"517-526"},"PeriodicalIF":5.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}