Michelle Katz, Christof Kazda, Jie Xue, Juan Frías, Ronald Brazg, Jit Mitra, Stephanie Gleissner, Eyal Dassau
{"title":"Safety and Functionality of a Novel Clinical Decision-Support Algorithm with Insulin Efsitora Alfa in Adults with Type 2 Diabetes: Early Feasibility Study.","authors":"Michelle Katz, Christof Kazda, Jie Xue, Juan Frías, Ronald Brazg, Jit Mitra, Stephanie Gleissner, Eyal Dassau","doi":"10.1089/dia.2025.0051","DOIUrl":"10.1089/dia.2025.0051","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> For people with type 2 diabetes (T2D), optimal glycemic control is critical. Digital health interventions are a practical approach to improve T2D self-management. This study explored the safety and functionality of a novel clinical decision-support (CDS) application for individualized dosing of insulin efsitora (efsitora), a once-weekly basal insulin receptor agonist. <b><i>Participants and Methods:</i></b> This was a 16-week, multicenter, open-label early feasibility study in adults with T2D with or without basal insulin. Investigators requested an efsitora dose from the CDS algorithm and either overrode or accepted the recommendation. Dose recommendation overrides (primary endpoint), finger-stick glucose, blinded continuous glucose monitoring metrics, and hypoglycemic events were evaluated. <b><i>Results:</i></b> Two sequential cohorts consisted of 68 participants; each cohort included insulin-naïve and basal-switch participants. In both cohorts, mean glycated hemoglobin (HbA1c) for basal-switch participants ranged from 7.9% to 8.5%. Mean HbA1c for insulin-naïve participants ranged from 8.1% to 8.3%. CDS dosing recommendation overrides occurred for 0.7% of injections for basal-switch participants and for 1.0% of injections for insulin-naïve participants in Cohort 1. For Cohort 2, overrides occurred for 1.3% of injections for insulin-naïve participants, with no overrides for basal-switch participants. HbA1c was significantly reduced <i>(P</i> < 0.05) from baseline to Week 16 in both subgroups for both cohorts. The proportion of participants with fasting blood glucose within the targets increased from baseline to Week 16 in both subgroups for both cohorts. No level 3 hypoglycemia was observed. <b><i>Conclusions:</i></b> The novel CDS algorithm showed promising clinical performance and favorable investigator confidence as determined by a low rate of dose overrides.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"737-746"},"PeriodicalIF":6.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144062631","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}
Martina Zahradnická, Lenka Nemétová, Michal Kahle, David Vávra, Robert Bém, Peter Girman, Martin Haluzík, František Saudek
{"title":"Glucose Control in Type 1 Diabetes after Pancreas Transplantation: Does Automated Delivery Offer Comparable Results?","authors":"Martina Zahradnická, Lenka Nemétová, Michal Kahle, David Vávra, Robert Bém, Peter Girman, Martin Haluzík, František Saudek","doi":"10.1089/dia.2024.0606","DOIUrl":"10.1089/dia.2024.0606","url":null,"abstract":"<p><p><b><i>Objectives:</i></b> Pancreas transplantation provides long-term near-normal glycemic control for recipients with type 1 diabetes, but it is unknown how this control compares with an automated insulin delivery (AID) system. <b><i>Methods:</i></b> In this prospective study, we compared parameters from 31 consecutive pancreas-kidney transplantation recipients versus from 377 people using an AID-either MiniMed<sup>TM</sup> 780G (<i>n</i> = 200) or Tandem t:slim X2<sup>TM</sup> Control-IQ<sup>TM</sup> (<i>n</i> = 177). <b><i>Results:</i></b> Compared with the MiniMed and Tandem AID groups, transplant recipients at 1 month (mean ± standard deviation [SD]: 36 ± 12 days) after pancreas transplantation exhibited significantly lower glycated hemoglobin (38 mmol/mol [36, 40] vs. 55 [53, 56.5] and 56 [54.7, 57.2], respectively), lower mean glycemia (6.4 mmol/L [6, 6.8] vs. 8.5 [8.3, 8.7] and 8.2 [8.0, 8.4], respectively), and spent more time in range (90% [86, 93] vs. 72% [70, 74] and 75% [73, 77], respectively). Time in hypoglycemia did not differ significantly between the groups. <b><i>Conclusions:</i></b> Overall, compared with AID treatment, pancreas transplantation led to significantly better diabetes control parameters, with the exception of time below range. Clinical trials registration number is Eudra CT No. 2019-002240-24.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"728-736"},"PeriodicalIF":6.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143699972","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}
Grazia Aleppo, Peter Calhoun, Ryan Bailey, Jordan E Pinsker, Carol J Levy, John W Lum, Roy W Beck
{"title":"Reduction of Postprandial Glucose Excursions in Adults, Adolescents, and Children with Type 1 Diabetes Using Ultra-Rapid Lispro Insulin and Control-IQ+ Technology.","authors":"Grazia Aleppo, Peter Calhoun, Ryan Bailey, Jordan E Pinsker, Carol J Levy, John W Lum, Roy W Beck","doi":"10.1089/dia.2025.0077","DOIUrl":"10.1089/dia.2025.0077","url":null,"abstract":"<p><p>This study evaluated the effects of ultra-rapid lispro (URLi) insulin versus insulin lispro on postprandial glucose excursions in 176 individuals with type 1 diabetes using Control-IQ+ technology. Postprandial glycemia differed the most between URLi and lispro at 60 min (mean glucose 166 ± 69 mg/dL vs. 178 ± 70 mg/dL; adjusted mean difference [AMD] = -11 mg/dL; <i>P</i> < 0.001). The URLi had slightly lower mean glucose excursion compared with lispro (AMD = -4 mg/dL; <i>P</i> = 0.001), but the differences between treatments were larger following breakfast (AMD = -9 mg/dL) compared with lunch (AMD = -2 mg/dL) and dinner (AMD = -2 mg/dL). Participants with insulin-to-carbohydrate ratio (ICR) <5 g/U had a larger treatment group difference favoring URLi on mean glucose excursion (AMD = -11 mg/dL) compared with those with ICR 5-15 g/U (AMD = -2 mg/dL) and ICR >15 g/U (AMD = 1 mg/dL). In conclusion, compared with insulin lispro, the use of URLi with Control-IQ+ technology modestly improved postprandial glucose excursions with the greatest amount of improvement for breakfast and in those with insulin resistance.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"753-759"},"PeriodicalIF":6.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143763290","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}
Emilie B Lindkvist, Ajenthen G Ranjan, Kristen Nørgaard, Jannet Svensson
{"title":"Long-Term Glycemic Benefits and User Interaction Insights: Real-World Outcomes of Automated Insulin Delivery Use in a Pediatric Population.","authors":"Emilie B Lindkvist, Ajenthen G Ranjan, Kristen Nørgaard, Jannet Svensson","doi":"10.1089/dia.2025.0068","DOIUrl":"10.1089/dia.2025.0068","url":null,"abstract":"<p><p><b><i>Background:</i></b> Automated insulin delivery (AID) systems improve glycemic outcomes, but the roles of user interaction and insulin pump settings in these findings remain underexplored. <b><i>Objective:</i></b> To investigate how AID initiation influenced glycemic outcomes over a year and assess the impact of user behavior and insulin pump settings. <b><i>Methods:</i></b> This was a retrospective observational study on real-world data from 156 pediatric individuals initiating AID (Tandem Control-IQ or MiniMed<sup>TM</sup> 780G). Data collected at baseline and a year following AID initiation included measures of glycemic outcomes, user interaction (e.g., daily meals, carbohydrates, and user-initiated insulin bolus), and insulin pump settings. <b><i>Results:</i></b> Percentage of time in range (TIR: 3.9-10.0 mmol/L) improved after AID initiation and remained stable over the follow-up year (baseline: 61.9% vs. month 12: 69.1%, <i>P</i> < 0.001). The percentage of individuals reaching target (TIR >70%) declined after an initial increase (baseline: 29.5% vs. month 1: 60.0% vs. month 12: 43.7%, <i>P</i> < 0.005). The predefined measures for user interaction also increased over a year, such as user-initiated insulin boluses (baseline: 53.7% of total daily dose [TDD] vs. month 12: 59.9% of TDD, <i>P</i> = 0.034), reduced carbohydrate intakes relative to body weight (baseline: 5.0 g/[kg·d] vs. month 12: 4.6 g/[kg·d], <i>P</i> = 0.004), and longer active continuous glucose monitoring (CGM) wear time (baseline: 87.2% vs. month 12: 94.1%, <i>P</i> = 0.011). A positive association between TIR and daily registered meals (<i>P</i> < 0.001) and daily registered carbohydrates (<i>P</i> = 0.003) was found in the multivariate analysis while adjusting for insulin pump settings and total daily insulin dose. <b><i>Conclusion:</i></b> Glycemic outcomes improved 12 months after AID initiation and were positively associated with the number of meal announcements and daily carbohydrates registered in the pump. User-initiated bolus insulin and percentage of active CGM wear time had no impact on AID performance. Our findings emphasize the importance of continuous assessment of diabetes management, even with advanced technology, as user engagement remains crucial.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"696-703"},"PeriodicalIF":6.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143763282","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}
Jesica D Baran, Charles Spanbauer, Rajlaxmi Bais, Hou-Hsien Chiang, Jing H Chao, Dori Khakpour, Patrisia Panfil, Francisco J Pasquel, Jagdeesh Ullal, Nikola Gligorijevic, Morgan S Jones, Cecilia C Low Wang, John B Buse, Boris Draznin, Judy Sibayan, Craig Kollman, Roy W Beck, Irl B Hirsch
{"title":"Dexcom G7 Accuracy and Reproducibility in the Intensive Care Unit.","authors":"Jesica D Baran, Charles Spanbauer, Rajlaxmi Bais, Hou-Hsien Chiang, Jing H Chao, Dori Khakpour, Patrisia Panfil, Francisco J Pasquel, Jagdeesh Ullal, Nikola Gligorijevic, Morgan S Jones, Cecilia C Low Wang, John B Buse, Boris Draznin, Judy Sibayan, Craig Kollman, Roy W Beck, Irl B Hirsch","doi":"10.1089/dia.2025.0184","DOIUrl":"10.1089/dia.2025.0184","url":null,"abstract":"<p><p><b><i>Objective:</i></b> To evaluate the accuracy of Dexcom G7 continuous glucose monitor (CGM) in the intensive care unit (ICU) setting. <b><i>Methods:</i></b> We performed a prospective, single-center study in patients with known diagnosis of diabetes or stress hyperglycemia and treated with insulin. Two Dexcom G7 sensors were placed on the abdomen and/or upper arm. Blood glucose (BG) measurements obtained according to usual ICU care were paired with sensor glucose values, and accuracy metrics were analyzed. For further comparison, non-ICU patients were also studied. <b><i>Results:</i></b> The analyses included 30 participants with mean ± standard deviation age of 55 ± 12 years, with preexisting diabetes in 40% and stress hyperglycemia in 60%. A total of 1515 sensor-BG pairs were analyzed. The mean difference (bias) was -12 mg/dL (median: -6), and the mean relative absolute difference (RAD) was 16% (median: 12%). Mean RAD was 13% (median: 9%) using plasma glucose as the reference and 17% (median: 13%) using capillary glucose. For comparison, in 35 adults with type 2 diabetes in a non-ICU setting, the mean RAD was 15% (median: 13%). No meaningful differences were observed across the duration of time since sensor insertion. No correlation was found between mean RAD and severity of illness. <b><i>Conclusions:</i></b> Mean RAD of the Dexcom G7 sensor in the ICU setting was slightly higher than the outpatient use labeling, but was similar to a non-ICU hospital setting. Further studies are needed to determine whether CGM can be used nonadjunctively in an ICU setting for insulin management, including use of glucose trends and alarms for hypoglycemia or hyperglycemia.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"747-752"},"PeriodicalIF":6.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143969386","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}
Kevin J Scully, Michelle Reed, Julia Douvas, Melissa S Putman, Brynn E Marks
{"title":"The Effect of Omnipod 5 Automated Insulin Delivery on Glycemic Control in Adolescents and Adults with Cystic Fibrosis-Related Diabetes.","authors":"Kevin J Scully, Michelle Reed, Julia Douvas, Melissa S Putman, Brynn E Marks","doi":"10.1089/dia.2025.0075","DOIUrl":"10.1089/dia.2025.0075","url":null,"abstract":"<p><p><b><i>Background:</i></b> Studies investigating the safety and efficacy of automated insulin delivery (AID) systems in people with cystic fibrosis-related diabetes are limited. There are no published studies investigating the tubeless Omnipod 5 (OP5) AID system. <b><i>Methods:</i></b> This dual-center retrospective cohort study compared 14 days of baseline continuous glucose monitoring (CGM) data with days 1-90 and 91-180 post-OP5 initiation. Multivariable mixed-effects linear regression models were used to assess changes in glycemic metrics. <b><i>Results:</i></b> Among the 26 individuals with sufficient data initiating OP5, 65% were female, with a median age of 27.3 years and median diabetes duration of 10.9 years. Six (23%) had a history of solid organ transplant, and 2 (8%) were receiving enteral tube feeds. Participants transitioned to OP5 from multiple daily injections (54%), prior Omnipod generation (31%), or another AID system (15%). CGM time in range (70-180 mg/dL) increased from 54% (95% confidence interval [CI]: 45.0, 63.0) to 64% (95% CI: 57, 71.8, <i>P</i> < 0.001) during the first 90 days and to 62.7% (95% CI: 54.9, 70.5, <i>P</i> < 0.001) during 91-180 days. Time above range (TAR) 181-250 mg/dL and TAR >250 mg/dL improved at 1-90 days and 91-180 days compared with baseline (<i>P</i> = 0.001 and <i>P</i> = 0.002, respectively). There were no significant changes in time below range (54-69 mg/dL, <54 mg/dL) or coefficient of variation. Two individuals discontinued OP5 within 14 days due to persistent hypoglycemia. One adult experienced a hypoglycemic seizure after 3 months of use. <b><i>Conclusions:</i></b> Use of the OP5 system in youth and adults with CFRD led to significant improvements in multiples measures of hyperglycemia without a change in CGM-measured hypoglycemia over a 6-month period, although patient experience with hypoglycemia may limit sustained use. Given the unique comorbidities and pathophysiology of CFRD, these results emphasize the need for future studies to investigate the safety and efficacy of AID devices in this patient population.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"711-718"},"PeriodicalIF":6.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12411085/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144062646","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alba Cuerda-Del Pino, Alejandro José Laguna Sanz, José-Luis Díez, Paolo Rossetti, Cynthia Marco Romero, F Javier Ampudia-Blasco, Jorge Bondia, Rodrigo Martín-San Agustín
{"title":"Accuracy of FreeStyle Libre 3 During Moderate-Intensity Continuous Aerobic Exercise at Different Phases of the Menstrual Cycle in Females with Type 1 Diabetes.","authors":"Alba Cuerda-Del Pino, Alejandro José Laguna Sanz, José-Luis Díez, Paolo Rossetti, Cynthia Marco Romero, F Javier Ampudia-Blasco, Jorge Bondia, Rodrigo Martín-San Agustín","doi":"10.1089/dia.2024.0558","DOIUrl":"10.1089/dia.2024.0558","url":null,"abstract":"<p><p><b><i>Background:</i></b> The use of continuous glucose monitoring (CGM) devices in managing type 1 diabetes (T1D) has been associated with improved glycemic control in individuals with T1D. A key challenge for CGMs, however, is achieving accuracy, particularly under conditions where glucose levels may fluctuate rapidly, such as during exercise. Another factor contributing to blood glucose variability is the menstrual cycle, during which hormonal fluctuations affect insulin sensitivity, leading to variable glucose levels. This study aimed to assess the accuracy of FreeStyle Libre-3 (FSL3) during continuous moderate-intensity aerobic exercise (CONT) performed in the follicular and luteal phases of the menstrual cycle in females with T1D. <b><i>Methods:</i></b> Participants underwent CONT sessions on a cycle ergometer, one in the follicular phase and one in the luteal phase of the menstrual cycle, at the Research Laboratory of the Faculty of Physiotherapy. Glucose levels were measured every 10 min using FSL3 and the YSI 2500 as a gold standard. Measurements began 20 min before CONT and continued for 20 min after exercise. <b><i>Results:</i></b> A total of 26 females (mean age 32.2 ± 6.1 years and mean duration of diabetes 16.4 ± 8.4 years) participated in this study. FSL3 showed significant differences compared with YSI glucose data for both phases of the menstrual cycle (about 16 mg/dL higher in FSL3). There were no differences in mean absolute relative differences (MARDs) between the follicular (16.06%) and luteal (16.43) phases. Moreover, exercise did not affect MARDs, which were 14.21% pre-exercise and 17.63% postexercise for the follicular phase and 14.95% pre-exercise and 17.71% postexercise for the luteal phase. <b><i>Conclusions:</i></b> The findings suggest that the accuracy of FSL3 is not affected by CONT, showing good accuracy levels in both phases of the menstrual cycle. Thus, this study is the first to examine the influence of the menstrual cycle and exercise on the accuracy of a CGM device. The study was also prospectively registered at clinicaltrials.gov (NCT06086067).</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"687-695"},"PeriodicalIF":6.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143990724","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}
Nithya Kadiyala, Rama Lakshman, Janet Allen, Julia Ware, Charlotte K Boughton, Malgorzata E Wilinska, Ajay Thankamony, Sara Hartnell, Hood Thabit, Ruben H Willemsen, Pratik Shah, Roman Hovorka
{"title":"Fully Closed-Loop Improves Glycemic Control Compared with Pump with CGM in Adolescents with Type 1 Diabetes and HbA1c Above Target: A Two-Center, Randomized Crossover Study.","authors":"Nithya Kadiyala, Rama Lakshman, Janet Allen, Julia Ware, Charlotte K Boughton, Malgorzata E Wilinska, Ajay Thankamony, Sara Hartnell, Hood Thabit, Ruben H Willemsen, Pratik Shah, Roman Hovorka","doi":"10.1089/dia.2025.0062","DOIUrl":"10.1089/dia.2025.0062","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> Adolescents with type 1 diabetes (T1D) can struggle to reach recommended HbA1c targets more than other age groups. The safety and efficacy of fully closed-loop (FCL) insulin delivery, which does not require mealtime bolusing, have not been assessed in this cohort. We evaluated the use of FCL with faster insulin aspart (Fiasp) in adolescents with T1D whose HbA1c was above recommended targets. <b><i>Materials and Methods:</i></b> This two-center, randomized, crossover study included 24 adolescents (13-19 years) using insulin pump therapy with above-target HbA1c (mean age 16.2 years, median HbA1c 74 mmol/mol [8.9%]). Participants underwent two 8-week periods of unrestricted living, comparing FCL (CamAPS HX) with Fiasp, with standard nonautomated insulin pump therapy with continuous glucose monitoring (CGM), in random order. <b><i>Results:</i></b> In an intention-to-treat analysis, the percentage of time glucose was in target range (primary endpoint 3.9-10.0 mmol/L) was higher during FCL than during pump with CGM use (mean ± standard deviation [SD]) 45.2% ± 7.2% vs. 32.3% ± 12.8%, mean difference 12.9 percentage points, 95% confidence interval [CI] 8.5 to 17.3, <i>P</i> < 0.001). Time spent in hyperglycemia >13.9 mmol/L and mean glucose were lower with FCL compared with pump with CGM (median time >13.9 mmol/L 28.7% vs. 39.6%, difference -7.3 percentage points, 95% CI -11.1 to -3.5, <i>P</i> < 0.001; mean glucose 11.1 mmol/L vs. 12.7 mmol/L, difference -1.2 mmol/L, 95% CI -1.8 to -0.5, <i>P</i> < 0.001). Proportion of time with glucose <3.9 mmol/L was similar between interventions (median: FCL 2.78% vs. pump with CGM 2.97%, difference -0.34 percentage points, 95% CI -1.03 to 0.35, <i>P</i> = 0.322). There was no difference in HbA1c after FCL compared with pump with CGM (median: 71 mmol/mol (8.6%) vs. 74 mmol/mol (8.9%), <i>P</i> = 0.227). There was no difference in total daily insulin dose (<i>P</i> = 0.276). No severe hypoglycemia or ketoacidosis occurred. <b><i>Conclusions:</i></b> FCL insulin delivery with CamAPS HX improved glucose outcomes compared with insulin pump therapy with CGM in adolescents with T1D and HbA1c above target.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"719-727"},"PeriodicalIF":6.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144186675","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":"Hybrid Closed Loop in Adolescents and Young Adults Living with Type 1 Diabetes: A Real-World Study.","authors":"Marine Ung, Alfred Penfornis, Clarisse Valentim, Sylvia Franc, Coralie Amadou, Juliette Eroukhmanoff","doi":"10.1089/dia.2024.0528","DOIUrl":"10.1089/dia.2024.0528","url":null,"abstract":"<p><p>To evaluate the long-term metabolic outcomes and safety of hybrid closed loop (HCL) in youth living with type 1 diabetes, including people with very poor metabolic control, this observational, retrospective, monocentric study included 101 patients aged 15-25 years. After a mean (±standard deviation; range) follow-up of 16 (±6; 3-31) months, HbA1c decreased from 9.6% ± 2.3% (82 ± 25 mmol/mol) at baseline to 8.0% ± 1.4% (64 ± 15 mmol/mol) (<i>P</i> < 0.001). Continuous glucose monitoring parameters showed the same trend (<i>P</i> < 0.001): the glucose management indicator decreased from 8.8% to 7.9%, time in range increased from 39% to 57%, and time below range decreased from 3.0% to 1.6%. Ten patients discontinued HCL. There was no more severe hypoglycemia or diabetes ketoacidosis under HCL compared with the year before HCL initiation. Five cases of new onset and four cases of worsening retinopathy were reported. Youth with type 1 diabetes can improve metabolic control thanks to HCL without increasing complication risk. Vigilance is required for preexisting retinopathy monitoring.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"760-764"},"PeriodicalIF":6.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143965798","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}
Stefano Passanisi, Bruno Bombaci, Mattia Papa, Serena Rollato, Irene Cuccurullo, Felice Citriniti, Susanna Coccioli, Rosaria De Marco, Ludovica Fedi, Stefano Gualtieri, Nicola Lazzaro, Marilea Lezzi, Maria C Lia, Donatella Lo Presti, Giulia Pezzino, Elvira Piccinno, Filomena Stamati, Rita Tutino, Marilena Travagliante, Clara Zecchino, Dario Iafusco, Fortunato Lombardo
{"title":"Evaluation of an Automated Insulin Delivery System in the Management of Postprandial Glucose Levels During a Pediatric School Camp: The Control-IQ Potato Challenge.","authors":"Stefano Passanisi, Bruno Bombaci, Mattia Papa, Serena Rollato, Irene Cuccurullo, Felice Citriniti, Susanna Coccioli, Rosaria De Marco, Ludovica Fedi, Stefano Gualtieri, Nicola Lazzaro, Marilea Lezzi, Maria C Lia, Donatella Lo Presti, Giulia Pezzino, Elvira Piccinno, Filomena Stamati, Rita Tutino, Marilena Travagliante, Clara Zecchino, Dario Iafusco, Fortunato Lombardo","doi":"10.1089/dia.2025.0064","DOIUrl":"10.1089/dia.2025.0064","url":null,"abstract":"<p><p><b><i>Background:</i></b> Potatoes are a staple food, especially in pediatric populations, but they pose distinct challenges for individuals with type 1 diabetes (T1D). This study evaluated glycemic responses in youth with T1D using a second-generation automated insulin delivery system after consuming potatoes prepared by two methods: fried and boiled. <b><i>Methods:</i></b> The study was conducted during a 5-day school camp for unaccompanied youth with T1D, aged 11-17 years, who had been using the Tandem t:slim X2™ Control-IQ insulin pump for at least 6 months. On two separate days, participants consumed a standardized meal containing 240 g of either fried or boiled potatoes, considered as 38 g of carbohydrates. Continuous glucose monitoring (CGM) data were collected and analyzed for all participants. <b><i>Results:</i></b> Our study population consisted of 31 children and adolescents (mean age 14.2 ± 1.7 years). Time in range was slightly higher after consuming boiled potatoes compared with fried potatoes, though the difference was not statistically significant (73.7% vs. 67.8%; <i>P</i> = 0.225). Mean glucose changes from pre-meal to 3-h post-meal were comparable between groups (-34.3 vs. -25.4 mg/dL; <i>P</i> = 0.517). Similarly, no significant differences were observed in the area under the curve of glucose levels. However, the percentage of bolus insulin within the 3-h post-meal period tended to be higher after fried potato consumption (20.7% vs. 11.9%; <i>P</i> = 0.075). <b><i>Conclusions:</i></b> Despite differences in glycemic index and fat content, the Tandem t:slim X2 Control-IQ system effectively maintained satisfactory glucose control within the 3-h post-meal period for both fried and boiled potatoes.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"704-710"},"PeriodicalIF":6.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143968770","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}