Satish K Garg, Timothy S Bailey, Kristin Castorino, Mark P Christiansen, David R Liljenquist, Hernan Salazar, Halis Kaan Akturk, Sharon Gao, Matthew L Johnson, Stayce E Beck
{"title":"Accuracy of the 15.5-Day G7 iCGM in Adults with Diabetes.","authors":"Satish K Garg, Timothy S Bailey, Kristin Castorino, Mark P Christiansen, David R Liljenquist, Hernan Salazar, Halis Kaan Akturk, Sharon Gao, Matthew L Johnson, Stayce E Beck","doi":"10.1089/dia.2025.0139","DOIUrl":"https://doi.org/10.1089/dia.2025.0139","url":null,"abstract":"<p><p><b><i>Background:</i></b> Continuous glucose monitors (CGM) are increasingly being used to manage diabetes. We evaluated the performance and safety of an investigational 15-day G7 integrated CGM (iCGM; Dexcom) in adults with diabetes. <b><i>Methods:</i></b> This prospective, multicenter study enrolled adults (age ≥18 years) with type 1 diabetes (T1D) or type 2 diabetes (T2D) at six clinical sites in the United States. Four in-clinic visits were conducted on days 1-3, 4-7, 9-12, and 13-15.5, with frequent arterialized venous blood draws for comparator measurements using a Yellow Springs Instrument (YSI) 2300 Stat Plus glucose analyzer. Participants with T1D or T2D using intensive insulin therapy participated in clinic sessions with deliberate, closely monitored glucose manipulations. Accuracy evaluations included the mean absolute relative difference (MARD), proportion of CGM values within 15 mg/dL of YSI values <70 mg/dL or within 15% of YSI values ≥70 mg/dL (%15/15), as well as %20/20, %30/30, and %40/40 agreement rates. Performance related to iCGM special controls, user experience, and device safety were also assessed. <b><i>Results:</i></b> The study enrolled 130 adults with diabetes (mean ± standard deviation age 43.0 ± 14.4 years, 53.1% female, 86.9% with T1D) and analyzed 20,310 CGM-YSI matched pairs from 130 15-day G7 CGM devices. The overall MARD was 8.0% and the %15/15, %20/20, %30/30, and %40/40 agreement rates were 87.7%, 94.2%, 98.9%, and 99.8%, respectively. The device exceeded iCGM performance goals, and user experiences were broadly positive. No serious adverse events were reported. <b><i>Conclusions:</i></b> The 15-day G7 iCGM was accurate and safe in adults with diabetes throughout the 15.5-day wear period. <b><i>Clinicaltrials.gov:</i></b> NCT05263258.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662528","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}
Tejal Patel, Nathan Grant L Sala, Natalie A Macheret, Sophia B Glaros, Sydney D Dixon, Abby Meyers, Eleanor Mackey, Elizabeth Estrada, Stephanie T Chung
{"title":"Continuous Glucose Monitoring Use in Youth with Type 2 Diabetes: A Pilot Randomized Study.","authors":"Tejal Patel, Nathan Grant L Sala, Natalie A Macheret, Sophia B Glaros, Sydney D Dixon, Abby Meyers, Eleanor Mackey, Elizabeth Estrada, Stephanie T Chung","doi":"10.1089/dia.2024.0539","DOIUrl":"https://doi.org/10.1089/dia.2024.0539","url":null,"abstract":"<p><p><b><i>Objective:</i></b> Continuous glucose monitoring (CGM) enhances diabetes self-management in insulin-treated individuals. However, the feasibility, acceptability, and benefits/burdens in youth-onset type 2 diabetes (Y-T2D) who are on infrequent self-monitoring of blood glucose (SMBG) regimens remain unclear. <b><i>Research Design and Methods:</i></b> In Y-T2D prescribed SMBG less than or equal to twice daily, we conducted a 12-week randomized 2:1 parallel pilot trial of CGM versus fingerstick monitoring (Control). Control participants had an optional 4-week extension period to use CGM (Control-CGM). Feasibility was defined as recruitment, study participation, and retention >60% of individuals. Acceptability was defined as an individual CGM wear time of ≥60% at the end of the study. Diabetes distress and the benefits/burdens of CGM scores, hemoglobin A1c (HbA1c), and CGM-derived glycemic variables were compared at baseline and at the end of the intervention. <b><i>Results:</i></b> The recruitment rate was 54% (52 screened eligible, 18 CGM, 10 Control; 82% female, 68% Black, 14.9 ± 3.8 years, body mass index: 36.2 ± 7.7 kg/m<sup>2</sup>, HbA1c: 7.4 ± 2.4% (mean ± standard deviation [SD]), and 8 entered the optional Control-CGM group. The most commonly cited reason for declining study participation was reluctance to wear the device (50%). The participation rate was 91% and 75%, and retention was 100% and 75% for CGM and Control-CGM, respectively. A majority of Y-T2D had ≥60% wear time at the end of the study (CGM: 56% and Control-CGM: 83%). Wear time declined during the study (1st month: 71 ± 31% vs. 2nd month: 55 ± 32% vs. 3rd month: 38 ± 34%, <i>P</i> = 0.003). There were no significant changes in glycemia, CGM burden/benefits, or diabetes distress scores (<i>P</i> > 0.05). Minor sensor adhesion adverse events were common (75%) causes of reduced wear time. <b><i>Conclusion:</i></b> CGM was a feasible and acceptable adjunct to diabetes self-care among >50% of Y-T2D prescribed infrequent SMBG monitoring. Unwillingness to wear a device and social stigma impeded device use. Additional research is needed to mitigate the high rates of skin adhesion-related adverse events in this population.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647646","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}
Jennifer M Ladd, Kajal Gandhi, Kelly Friesner-Gephart, Robert P Hoffman, Mary Joy Okafor, Christie Heinzman, Cheryl E Gariepy, Sara K Rasmussen, Jaimie D Nathan, A Jay Freeman
{"title":"Accuracy of Two Continuous Glucose Monitors Differs after Hydroxyurea in Pediatric Patients Undergoing Total Pancreatectomy with Islet Autotransplantation.","authors":"Jennifer M Ladd, Kajal Gandhi, Kelly Friesner-Gephart, Robert P Hoffman, Mary Joy Okafor, Christie Heinzman, Cheryl E Gariepy, Sara K Rasmussen, Jaimie D Nathan, A Jay Freeman","doi":"10.1089/dia.2025.0010","DOIUrl":"https://doi.org/10.1089/dia.2025.0010","url":null,"abstract":"<p><p><b><i>Background:</i></b> Total pancreatectomy with islet autotransplantation (TPIAT) requires strict glycemic management for islet survival using insulin pumps and continuous glucose monitors (CGMs). Hydroxyurea prevents reactive thrombocytosis but interferes with the accuracy of the Dexcom CGM. Hydroxyurea is reported to not interfere with the Libre CGM but has not been studied after TPIAT. <b><i>Methods:</i></b> Seven patients wore both Dexcom and Libre starting approximately a week after TPIAT. Dexcom and Libre values were obtained with point-of-care testing blood glucose (POCT BG) at 560 unique time points. Descriptive statistics included median, interquartile range (IQR), absolute difference between CGM and POCT, and mean absolute relative difference (MARD) for each Dexcom and Libre. Wilcoxon-Mann-Whitney tests were performed to compare parameters between Dexcom and Libre, with two-sided significance of <i>P</i> < 0.05. Clarke error grids and boxplots were constructed. <b><i>Results:</i></b> In the 9 h after hydroxyurea, median POCT BG was 110 mg/dL (IQR 88-143), median Dexcom BG was 172 mg/dL (135-219), and median Libre BG was 106 mg/dL (76-138). MARD for Dexcom was 59.5% and for Libre was 14.8% (<i>P</i> < 0.001). Median absolute difference between Dexcom and POCT BG (56 mg/dL [32-88]) was greater than that for Libre (12 mg/dL [6-23]; <i>P</i> < 0.001). In Clarke error grids, 98.3% of values fell within clinically acceptable Zones A/B for Libre; 77.9% of values fell within these zones for Dexcom. At all other times, median POCT BG was 110 mg/dL (86-133), median Dexcom BG was 124 mg/dL (97-154), and median Libre BG was 104 mg/dL (76-128). MARD for Dexcom was 19.8% and for Libre was 14.7% (<i>P</i> < 0.001). Median absolute difference between Dexcom and POCT BG (18 mg/dL [9-30]) was clinically similar to that for Libre (13 mg/dL [6-23], <i>P</i> < 0.001). <b><i>Conclusion:</i></b> Hydroxyurea does not seem to interfere with the accuracy of Libre in contrast to Dexcom. Use of Libre after TPIAT could facilitate improved glycemic management.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656266","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}
Erik H Serné, Maria Ida Buompensiere, Simona de Portu, Jayne Smith-Palmer, Johannes Pöhlmann, Ohad Cohen
{"title":"Automated Insulin Delivery Versus Standard of Care in the Management of People Living with Type 1 Diabetes and HbA1c <8%: A Cost-Utility Analysis in The Netherlands.","authors":"Erik H Serné, Maria Ida Buompensiere, Simona de Portu, Jayne Smith-Palmer, Johannes Pöhlmann, Ohad Cohen","doi":"10.1089/dia.2024.0647","DOIUrl":"https://doi.org/10.1089/dia.2024.0647","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> Automated insulin delivery (AID) systems improve glycemic control in people living with type 1 diabetes (PwT1D). AID is cost-effective versus other management approaches in a range of country settings and populations. This cost-utility analysis adds an evaluation of the MiniMed<sup>TM</sup> 780G system versus standard of care (SoC) in PwT1D and baseline glycated hemoglobin (HbA1c) level <8% not reaching glycemic targets, conducted from a societal perspective in The Netherlands. <b><i>Methods:</i></b> The analysis was run using the IQVIA CORE Diabetes Model, over 50 years. Costs were discounted at 3% per year, effects at 1.5% per year. Baseline cohort characteristics and treatment effects were sourced from the MiniMed 780G arm of a prospective multicenter study. Costs and utility estimates were taken from Dutch databases and published sources. Sensitivity analyses were conducted to address uncertainty. <b><i>Results:</i></b> AID improved life expectancy by 0.52 years and quality-adjusted life expectancy by 0.99 quality-adjusted life-years (QALYs) versus SoC. AID was associated with an incremental combined cost of EUR 28,635 due to higher acquisition costs, which were partially offset by reduced direct treatment costs for diabetes-related complications and reduced indirect costs due to less time off work. Based on combined costs, the MiniMed 780G system was associated with an incremental cost-utility ratio of EUR 29,836 per QALY gained. <b><i>Conclusions:</i></b> For PwT1D in The Netherlands, who had a baseline HbA1c <8% and do not reach glycemic targets, AID system initiation was projected to improve long-term clinical outcomes and reduce both direct costs for the treatment of diabetes-related complications and productivity losses. From a societal perspective, the MiniMed 780G likely represents good value for money in The Netherlands.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647643","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}
Pavel Fatulla, Henrik Imberg, Sofia Sterner Isaksson, Irl B Hirsch, Johan Mårtensson, Hanna Liljebäck, Tim Heise, Marcus Lind
{"title":"Evaluating the Adequacy of Coefficient of Variation and Standard Deviation as Metrics of Glucose Variability in Type 1 Diabetes Based on Data from the GOLD and SILVER Trials.","authors":"Pavel Fatulla, Henrik Imberg, Sofia Sterner Isaksson, Irl B Hirsch, Johan Mårtensson, Hanna Liljebäck, Tim Heise, Marcus Lind","doi":"10.1089/dia.2024.0540","DOIUrl":"https://doi.org/10.1089/dia.2024.0540","url":null,"abstract":"<p><p><b><i>Objective:</i></b> Evaluate the adequacy of the coefficient of variation (CV) and standard deviation (SD) as metrics of glucose variability (GV) across mean glucose (MG) levels in individuals with type 1 diabetes. <b><i>Methods:</i></b> Data from the GOLD and SILVER trials were analyzed. Glucose metrics were derived from continuous glucose monitoring (CGM). Generalized estimating equations were used to assess the relationship between SD and MG, considering intraindividual correlations. Nonlinear associations were evaluated using restricted cubic splines, and glucose values outside the CGM detection range (<2.22 mmol/L and >22.2 mmol/L) were handled using a censored Gamma model. <b><i>Results:</i></b> In total, 158 individuals with an MG of 10.6 (SD 1.7) mmol/L were included. The SD of glucose values exhibited a nonlinear relationship with the MG during CGM and self-monitoring of blood glucose (SMBG) (both <i>P</i> < 0.001 vs. linear model). The lack of fit of the constant CV model was most distinct at high glucose levels >12 mmol/L. During SMBG, a 25% reduction in MG from 12 to 9 mmol/L was associated with a 16% (95% confidence interval [CI] 10%-21%) reduction in the SD of glucose values. Similar associations were observed during CGM. This deviation was attributed to the censoring of glucose values outside the detection range. After adjusting for censoring, the lack of fit was resolved. When transitioning from SMBG to CGM, the ordinary CV and SD underestimated the treatment effect on GV by 30% and 27%, respectively, compared to estimates adjusted for censoring. Similarly, ordinary CV underestimated the treatment effect by 11% compared with CV adjusted for the nonlinear SD-MG relationship in the GOLD study. <b><i>Conclusion:</i></b> The SD of glucose values does not increase linearly with the MG during glucose-lowering therapy, suggesting that CV is not an optimal measure of GV. After adjusting for censored glucose values, CV remains reliable. Alternatively, nonlinear SD adjustments relative to MG effectively evaluate glucose-lowering therapies' impact on GV.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656267","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}
Zekai Wu, Maha Lebbar, Anne Bonhoure, Marie Raffray, Marie Devaux, Caroline Grou, Virginie Messier, Valérie Boudreau, Andréanne Vanasse, Anne-Sophie Brazeau, Rémi Rabasa-Lhoret
{"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":"https://doi.org/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":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-18","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}
Yong Du, Jens Baumert, Maike Buchmann, Reinhard W Holl, Christin Heidemann
{"title":"Use of Glucose Monitoring Devices Among Adults with Diabetes in Germany: Results from Nationwide Surveys Conducted in 2017 and 2021/2022.","authors":"Yong Du, Jens Baumert, Maike Buchmann, Reinhard W Holl, Christin Heidemann","doi":"10.1089/dia.2024.0623","DOIUrl":"https://doi.org/10.1089/dia.2024.0623","url":null,"abstract":"<p><p><b><i>Background:</i></b> Devices for continuous glucose monitoring (CGM) have been developed to optimize blood glucose control and liberate people with diabetes from finger-prick glucose measurements. Since 2016, the devices have been reimbursed in Germany for people with diabetes receiving insulin therapy, resulting in their increased use among people with type 1 diabetes (T1D) and type 2 diabetes (T2D). We investigated the prevalence of CGM use and its associated factors among German adults with diabetes in 2017 and 2021/2022. <b><i>Methods:</i></b> Participants aged 18 years or older with diagnosed diabetes were identified from two nationwide population-based telephone surveys in 2017 (<i>n</i> = 1396) and 2021/2022 (<i>n</i> = 1456). Prevalence and dynamics of CGM use were examined overall and stratified by sociodemographic and diabetes-related characteristics. Factors associated with CGM use were obtained from logistic regression models. <b><i>Results:</i></b> The overall prevalence of CGM use was 8.2% in 2017 and 16.6% in 2021/2022. An increase in CGM use was observed across all the subgroups except for those without antidiabetic medications. CGM use increased from 31.1% to 75.4% in adults with T1D, from 6.3% to 13.6% in adults with T2D, and from 14.6% to 36.7% in all insulin users. In both surveys, younger age, insulin use, T1D, and reporting hypoglycemia were associated with CGM use. In addition, in 2017, higher education level and absence of obesity were associated with CGM use, whereas in 2021/2022, participation in the diabetes self-management education program and higher self-assessed quality of diabetes care were associated with CGM use. <b><i>Conclusion:</i></b> Among adults with diabetes in Germany, CGM use increased about twofold within 5 years, irrespective of sociodemographic factors. Educational inequality in CGM use diminished over time. The higher self-rated quality of diabetes care associated with the recent use of CGM provides further evidence to support its use among all adults with diabetes in Germany.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647660","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}
Sara M Alexanian, Michael C Cheney, Jenny C Bello Ramos, Nicole L Spartano, Howard A Wolpert, Devin W Steenkamp
{"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":"https://doi.org/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<sub>70-180</sub>) 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<sub>70-180</sub> (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":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-11","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}
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
{"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":"https://doi.org/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":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-11","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}
Priscila Silva Cunegundes, Kenneth Wood, Li Mao, Ulrike Menkes
{"title":"Phenolic Preservatives Are Not the Sole Cause of Eosinophilic Infiltration at Infusion Pump Sites.","authors":"Priscila Silva Cunegundes, Kenneth Wood, Li Mao, Ulrike Menkes","doi":"10.1089/dia.2025.0043","DOIUrl":"10.1089/dia.2025.0043","url":null,"abstract":"<p><p><b><i>Background:</i></b> Skin reactions and discomfort associated with insulin infusion pumps limit user adherence. A recent histopathological study by Kalus et al. (DERMIS study) reported increased eosinophilic infiltration and imputed an inflammatory response to an allergen delivered at the catheter tip. This finding might explain the pruritus reported by pump users. As eosinophils migrate to inflammatory foci, primarily due to IL-5 and CCL11, we aimed to evaluate insulin phenolic preservative (IPP) as a potential allergen in vitro and assess tissue eosinophilic infiltration in vivo. <b><i>Methods:</i></b> Histopathological evaluations for eosinophil recruitment were performed over 1 week following IPP infusions in swine tissue. Additional histopathological investigations of eosinophilic infiltration were conducted using three commercial glucose sensors implanted in swine for up to 3 weeks. <b><i>Results:</i></b> Eosinophilic infiltration in the dermis and subcutaneous tissue was observed following saline and IPP infusion and at glucose sensor implantation at all time points examined. In vitro studies revealed IPP eosinophil cytotoxicity. However, neither CCL11 nor IL-5 was detected in any of the tested tissue cells after IPP treatment. <b><i>Conclusion:</i></b> These findings suggest that IPP is not the only triggering allergen, as IPP did not induce eosinophils in vitro, while glucose sensors also indicated increased eosinophilic infiltration. Therefore, factors other than IPP trigger eosinophil recruitment to insulin infusion pump sets.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604176","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}