Schafer Boeder, Michael J Davies, Janet B McGill, Richard Pratley, Manon Girard, Phillip Banks, Jeremy Pettus, Satish Garg
{"title":"Beta-Hydroxybutyrate Levels and Risk of Diabetic Ketoacidosis in Adults with Type 1 Diabetes Treated with Sotagliflozin.","authors":"Schafer Boeder, Michael J Davies, Janet B McGill, Richard Pratley, Manon Girard, Phillip Banks, Jeremy Pettus, Satish Garg","doi":"10.1089/dia.2023.0605","DOIUrl":"10.1089/dia.2023.0605","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> Sodium glucose cotransporter inhibitors may increase beta-hydroxybutyrate (BHB) in insulin-requiring patients. We determined factors associated with BHB changes from baseline (ΔBHB) and diabetic ketoacidosis (DKA) in patients with type 1 diabetes (T1D) receiving sotagliflozin as an insulin adjunct. <b><i>Research Design and Methods:</i></b> This post hoc analysis compared ΔBHB levels in adults with T1D receiving sotagliflozin 400 mg or placebo for 6 months. We evaluated clinical and metabolic factors associated with ΔBHB and used logistic regression models to determine predictors associated with BHB values >0.6 and >1.5 mmol/L (inTandem3 population; <i>N</i> = 1402) or with DKA events in a pooled analysis (inTandem1-3; <i>N</i> = 2453). <b><i>Results:</i></b> From baseline (median, 0.13 mmol/L), median fasting BHB increased by 0.04 mmol/L (95% confidence interval, 0.03-0.05; <i>P</i> < 0.001) at 24 weeks with sotagliflozin versus placebo; 67% of patients had no or minimal changes in BHB over time. Factors associated with on-treatment BHB >0.6 or >1.5 mmol/L included baseline BHB and sotagliflozin use. Age, insulin pump use, sotagliflozin use, baseline BHB, and ΔBHB were significantly associated with DKA episodes. Independent of treatment, DKA risk increased by 18% with each 0.1-mmol/L increase in baseline BHB and by 8% with each 0.1-mmol/L increase from baseline. <b><i>Conclusion:</i></b> Incremental increases in baseline BHB and ΔBHB were associated with a higher DKA risk independent of treatment. Adding sotagliflozin to insulin increased median BHB over 24 weeks in patients with T1D and was associated with increased DKA events. These results highlight the importance of BHB testing and monitoring and individualizing patient education on DKA risk, mitigation, identification, and treatment.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"618-625"},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11535465/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140027633","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}
Alanna Weisman, Gillian L Booth, Karl Everett, George A Tomlinson
{"title":"Recent Improvements in Attainment of the Hemoglobin A1c Target of ≤7.0% Among Adults with Type 1 Diabetes in Ontario: A Retrospective Cohort Study.","authors":"Alanna Weisman, Gillian L Booth, Karl Everett, George A Tomlinson","doi":"10.1089/dia.2024.0017","DOIUrl":"10.1089/dia.2024.0017","url":null,"abstract":"<p><p><b><i>Aims:</i></b> We evaluated attainment of the hemoglobin A1c (HbA1c) target of ≤7.0%, its temporal trends, and associated factors among adults with type 1 diabetes in Ontario, Canada, using administrative data. <b><i>Methods:</i></b> We conducted a retrospective cohort study, including Ontarians with type 1 diabetes ≥18 years old with ≥1 HbA1c test between April 1, 2012 (fiscal year 2013), and March 31, 2023. Generalized estimating equations were used to determine probabilities of meeting the HbA1c target, as well as associations between fiscal year and individual-, physician-, and system-level factors on odds of meeting the target. <b><i>Results:</i></b> Among 28,827 adults with type 1 diabetes [14,385 (49.9%) female, 17,998 (62.4%) pump users], with median age at index of 25 years [interquartile range (IQR) 18-37] and median diabetes duration of 12 years [6-18], there were 474,714 HbA1c tests [median 2/individual/year (IQR: 1-3)]. The model-estimated probability of meeting the HbA1c target of ≤7.0% was 22.1% (95% confidence interval, CI: 21.6 to 22.5) in 2013, remained stable until 2020, and increased to 34.7% (95% CI: 34.3 to 35.2) in 2023. The age- and sex-adjusted odds ratio for meeting the target in 2023 versus 2013 was 1.87 (95% CI: 1.79 to 1.96). Young adults (18-25 years), diabetic ketoacidosis, greater comorbidity, and receiving diabetes care from a nonspecialist physician were associated with reduced odds of meeting the HbA1c target. <b><i>Conclusions:</i></b> One-third of adults with type 1 diabetes in Ontario met the recommended HbA1c target of ≤7.0% in 2023, with improvement noted since 2021, which may be due to advanced technologies or effects of the COVID-19 pandemic.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"607-617"},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140206475","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}
Alex Mesa, Clara Solà, Irene Vinagre, Daria Roca, Montse Granados, Irene Pueyo, Carla Cabré, Ignacio Conget, Marga Giménez
{"title":"Impact of an Advanced Hybrid Closed-Loop System on Glycemic Control Throughout the Menstrual Cycle in Women with Type 1 Diabetes Prone to Hypoglycemia.","authors":"Alex Mesa, Clara Solà, Irene Vinagre, Daria Roca, Montse Granados, Irene Pueyo, Carla Cabré, Ignacio Conget, Marga Giménez","doi":"10.1089/dia.2023.0571","DOIUrl":"10.1089/dia.2023.0571","url":null,"abstract":"<p><p>This study aimed to evaluate the impact of advanced hybrid closed loop (AHCL) on glycemic control throughout the menstrual cycle (MC) in women with type 1 diabetes. We included 39 pairs of spontaneous MCs from 13 participants, before and after switching from sensor-augmented pump to AHCL. Baseline time below range <70 mg/dL (TBR <70) was significantly higher during the midfollicular phase than during late luteal phase (5.7% ± 5.0% vs. 4.1% ± 3.0%), but similar time in range 70-180 mg/dL (TIR) was observed throughout the MC. After switching to AHCL, a reduction in TBR <70 and an increase in TIR were observed in all phases. Phase-dependent changes in insulin infusion were detected and pre-existing differences in TBR <70 were eradicated (3.5% ± 3.2% vs. 3.0% ± 3.0%). However, TIR became significantly higher during the early follicular phase than during the late luteal phase (79.1% ± 9.3% vs. 74.5% ± 10.0%). In conclusion, AHCL improved glycemic control throughout the MC, but performance differed according to phase.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"667-672"},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140027634","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}
Lauren A Waterman, Laura Pyle, Gregory P Forlenza, Lindsey Towers, Angela J Karami, Emily Jost, Cari Berget, R Paul Wadwa, Erin C Cobry
{"title":"Accuracy of a Real-Time Continuous Glucose Monitor in Pediatric Diabetic Ketoacidosis Admissions.","authors":"Lauren A Waterman, Laura Pyle, Gregory P Forlenza, Lindsey Towers, Angela J Karami, Emily Jost, Cari Berget, R Paul Wadwa, Erin C Cobry","doi":"10.1089/dia.2023.0542","DOIUrl":"10.1089/dia.2023.0542","url":null,"abstract":"<p><p><b><i>Objective:</i></b> Continuous glucose monitoring (CGM) devices are integral in the outpatient care of people with type 1 diabetes, although they lack inpatient labeling. Food and Drug Administration began allowing inpatient use during the coronavirus disease 2019 (COVID-19) pandemic, with some accuracy data now available, primarily from adult hospitals. Pediatric inpatient data remain limited, particularly during diabetic ketoacidosis (DKA) admissions and for patients receiving intravenous (IV) insulin. <b><i>Design and Methods:</i></b> This retrospective chart review compared point-of-care glucose values to personal Dexcom G6 sensor data during pediatric hospitalizations. Accuracy was assessed using mean absolute relative difference (MARD), Clarke Error Grids, and the percentage of values within 15/20/30% if glucose value >100 mg/dL and 15/20/30 mg/dL if glucose value ≤100 mg/dL. <b><i>Results:</i></b> Matched paired glucose values (<i>N</i> = 612) from 36 patients (median age 14 years, 58.3% non-Hispanic White, 47.2% male) and 42 inpatient encounters were included in this subanalysis of DKA admissions. The MARDs for DKA and non-DKA admissions (<i>N</i> = 503) were 11.8% and 11.7%, with 97.6% and 98.6% of pairs falling within A and B zones of the Clarke Error Grid, respectively. Severe DKA admissions (pH <7.15 and/or bicarbonate <5 mmol/L) had a MARD of 8.9% compared to 14.3% for nonsevere DKA admissions. The MARD during administration of IV insulin (<i>N</i> = 266) was 13.4%. <b><i>Conclusions:</i></b> CGM accuracy is similar between DKA and non-DKA admissions and is maintained in severe DKA and during IV insulin administration, suggesting potential usability in pediatric hospitalizations. Further study on the feasibility of implementation of CGM in the hospital is needed.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"626-632"},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11535449/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140027632","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}
Carol J Levy, Ryan Bailey, Lori M Laffel, Gregory Forlenza, Linda A DiMeglio, Michael S Hughes, Sue A Brown, Grazia Aleppo, Anuj Bhargava, Viral N Shah, Mark A Clements, Mark Kipnes, Brittany Bruggeman, Mark Daniels, Henry Rodriguez, Peter Calhoun, John W Lum, Ravid Sasson-Katchalski, Jordan E Pinsker, Robyn Pollom, Roy W Beck
{"title":"Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes.","authors":"Carol J Levy, Ryan Bailey, Lori M Laffel, Gregory Forlenza, Linda A DiMeglio, Michael S Hughes, Sue A Brown, Grazia Aleppo, Anuj Bhargava, Viral N Shah, Mark A Clements, Mark Kipnes, Brittany Bruggeman, Mark Daniels, Henry Rodriguez, Peter Calhoun, John W Lum, Ravid Sasson-Katchalski, Jordan E Pinsker, Robyn Pollom, Roy W Beck","doi":"10.1089/dia.2024.0048","DOIUrl":"10.1089/dia.2024.0048","url":null,"abstract":"<p><p><b><i>Objective:</i></b> To evaluate the safety and explore the efficacy of use of ultra-rapid lispro (URLi, Lyumjev) insulin in the Tandem t:slim X2 insulin pump with Control-IQ 1.5 technology in children, teenagers, and adults living with type 1 diabetes (T1D). <b><i>Methods:</i></b> At 14 U.S. diabetes centers, youth and adults with T1D completed a 16-day lead-in period using lispro in a t:slim X2 insulin pump with Control-IQ 1.5 technology, followed by a 13-week period in which URLi insulin was used in the pump. <b><i>Results:</i></b> The trial included 179 individuals with T1D (age 6-75 years). With URLi, 1.7% (3 participants) had a severe hypoglycemia event over 13 weeks attributed to override boluses or a missed meal. No diabetic ketoacidosis events occurred. Two participants stopped URLi use because of infusion-site discomfort, and one stopped after developing a rash. Mean time 70-180 mg/dL increased from 65% ± 15% with lispro to 67% ± 13% with URLi (<i>P</i> = 0.004). Mean insulin treatment satisfaction questionnaire score improved from 75 ± 13 at screening to 80 ± 11 after 13 weeks of URLi use (mean difference = 6; 95% confidence interval 4-8; <i>P</i> < 0.001), with the greatest improvement reported for confidence avoiding symptoms of high blood sugar. Mean treatment-related impact measure-diabetes score improved from 74 ± 12 to 80 ± 12 (<i>P</i> < 0.001), and mean TRIM-Diabetes Device (score improved from 82 ± 11 to 86 ± 12 (<i>P</i> < 0.001). <b><i>Conclusions:</i></b> URLi use in the Tandem t:slim X2 insulin pump with Control-IQ 1.5 technology was safe for adult and pediatric participants with T1D, with quality-of-life benefits of URLi use perceived by the study participants. Clinicaltrials.gov registration: NCT05403502.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"652-660"},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140856733","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":"Noninvasive Real-Time Glucose Monitoring Is in the Near Future.","authors":"Irl B Hirsch, Amir Tirosh, Ami Navon","doi":"10.1089/dia.2024.0009","DOIUrl":"10.1089/dia.2024.0009","url":null,"abstract":"<p><p><b><i>Objective:</i></b> Since the introduction of continuous glucose monitoring (CGM) technology, developers have rigorously researched the feasibility of creating a noninvasive glucose monitoring device. In a recent pilot study, investigators reported a strong correlation between glucose values obtained from novel noninvasive monitoring device (GWave) values to venous and capillary glucose measurements. <b><i>Research Design and Methods:</i></b> We investigated whether the level of accuracy observed in the pilot study could be reproduced in a larger cohort, using a smaller third-generation manufacturable device (Gen III GWave) containing a standardized sensor chip that can be mass produced for commercial use. The evaluation assessed concordance with capillary blood glucose, reproducibility between two Gen III devices, and accuracy during insulin-induced hypoglycemia. <b><i>Results:</i></b> Assessment of samples from 75 subjects (type 2 diabetes, <i>n</i> = 6; type 1 diabetes, <i>n</i> = 28; nondiabetic pregnant subjects, <i>n</i> = 10; and nondiabetic, <i>n</i> = 31) showed that 97% of values were in Zone A with 3% in Zone B of the Clarke Error Grid, with a mean absolute relative difference of 6.7% from reference blood glucose. Comparison between two independent Gen III GWave devices demonstrated reproducibility between the sensors (<i>R</i><sup>2</sup> = 0.95), with 100% of values within Zone A. In the hypoglycemia assessment, measurements from the Gen III sensor tightly followed the capillary glucose measurements down to 42 mg/dL (2.3 mmol/L), whereas the CGM measurements from two different CGM only converged with the GWave and capillary glucose readings after 90 min of decreasing glucose levels. <b><i>Conclusion:</i></b> Our results show promise as potentially the first noninvasive technology. Future studies will focus on larger number of people in all glucose ranges. Real-time noninvasive blood glucose monitoring is possible using GWave technology.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"661-666"},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139989577","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":"Should We Bury HbA1c?","authors":"Laura B Bovee, Irl B Hirsch","doi":"10.1089/dia.2024.0028","DOIUrl":"10.1089/dia.2024.0028","url":null,"abstract":"","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"509-513"},"PeriodicalIF":5.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139729236","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}
Mark Warren, Richard M Bergenstal, Matthew Hager, Eran Bashan, Israel Hodish
{"title":"A Scalable Application of Artificial Intelligence-Driven Insulin Titration Program to Transform Type 2 Diabetes Management.","authors":"Mark Warren, Richard M Bergenstal, Matthew Hager, Eran Bashan, Israel Hodish","doi":"10.1089/dia.2024.0041","DOIUrl":"10.1089/dia.2024.0041","url":null,"abstract":"<p><p><b><i>Background:</i></b> Despite new pharmacotherapy, most patients with long-term type 2 diabetes are still hyperglycemic. This could have been solved by insulin with its unlimited potential efficacy, but its dynamic physiology demands frequent titrations which are overdemanding. This report provides a real-life account for a scalable transformation of diabetes care in a community-based endocrinology center by harnessing artificial intelligence-based autonomous insulin titration. <b><i>Methods:</i></b> The center embedded the d-Nav<sup>®</sup> technology and its dedicated clinical support. Reported outcomes include treatment efficacy/safety in the first 600 patients and use of cardiorenal-risk reduction pharmacotherapy. <b><i>Findings:</i></b> Patients used d-Nav for 8.2 ± 3.0 months with 82% retention. Age was 67.1 ± 11.5 years and duration of diabetes was 19.8 ± 11.0 years. During the last 3 years before d-Nav, glycated hemoglobin (HbA1c) had been overall higher than 8% and at the beginning of the program it was as high as 8.6% ± 2.1% with 29.3% of the patients with HbA1c >9%. With d-Nav, HbA1c decreased to 7.3% ± 1.2% with 5.7% of patients with HbA1c >9%. During the first 3 months, d-Nav reduced total daily dose of insulin in one of every five patients due to relatively low glucose levels to minimize the risk of hypoglycemia. Glucagon like peptide 1 (GLP-1) receptor agonists or dual GLP-1 and Glucose-dependent insulinotropic polypeptide (GIP) receptor agonists were prescribed in about a half of the patients and sodium glucose cotransporter 2 inhibitor in a third. The frequency of hypoglycemia (<54 mg/dL) was 0.4 ± 0.6/month and severe hypoglycemia 1.7/100-patient-years. <b><i>Interpretation:</i></b> The use of d-Nav allowed for improvement in overall diabetes management with appropriate use of both insulin and noninsulin pharmacologic agents in a scalable way.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"556-565"},"PeriodicalIF":5.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140058910","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}
Sarit Polsky, Elizabeth Buschur, Kathleen Dungan, Rachel Garcetti, Emily Nease, Emily Malecha, Anna Bartholomew, Carly Johnson, Laura Pyle, Janet Snell-Bergeon
{"title":"Randomized Trial of Assisted Hybrid Closed-Loop Therapy Versus Sensor-Augmented Pump Therapy in Pregnancy.","authors":"Sarit Polsky, Elizabeth Buschur, Kathleen Dungan, Rachel Garcetti, Emily Nease, Emily Malecha, Anna Bartholomew, Carly Johnson, Laura Pyle, Janet Snell-Bergeon","doi":"10.1089/dia.2024.0012","DOIUrl":"10.1089/dia.2024.0012","url":null,"abstract":"<p><p><b><i>Objective:</i></b> Examine gestational safety, glycemic and health outcomes, of a hybrid closed-loop (HCL) system without pregnancy-specific glucose targets. <b><i>Research Design:</i></b> This was a pilot feasibility investigator-initiated, two-site, single-blind, randomized controlled trial of sensor-augmented pump therapy (SAPT) versus HCL therapy in type 1 diabetes pregnancies. Participants were enrolled in the first trimester and randomized at 14-18 weeks of gestation and used SAPT or HCL until 4-6 weeks postpartum. We compared continuous glucose monitoring (CGM) metrics, severe hypoglycemia (SH), diabetic ketoacidosis (DKA), adverse skin reactions, and pregnancy outcomes between groups. <b><i>Results:</i></b> Baseline characteristics were similar between groups (<i>n</i> = 11 HCL and <i>n</i> = 12 SAPT). There was no SH or DKA episode after randomization. Time spent <54 mg/dL did not differ between groups. Time spent <63 mg/dL decreased in both groups, significantly in the HCL group (3.5% [1.3% standard error] second trimester and 2.8% [1.3%] third trimester vs. 7.9% [1.3%] run-in phase, <i>P</i> < 0.05 for both). Mean sensor glucose was lower with SAPT compared to HCL therapy in the third trimester (119 [4] mg/dL SAPT vs. 132 [4] mg/dL HCL, <i>P</i> < 0.05). Third trimester time-in-range (TIR; 63-140 mg/dL) increased with SAPT (68.2% [3.1%] vs. 64.3% [3.1%] run-in phase, <i>P</i> < 0.05). Gestational health outcomes did not differ between groups. The HCL group used assistive techniques, such as fake carbohydrate boluses and exiting HCL overnight. <b><i>Conclusions:</i></b> CGM within group differences were seen for time <63 mg/dL favoring HCL therapy and TIR favoring SAPT (third trimester vs. baseline). Safety and adverse pregnancy outcomes were similar between groups.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"547-555"},"PeriodicalIF":5.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139930414","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}
Rocío Villar-Taibo, Alba Galdón Sanz-Pastor, Elsa Fernández-Rubio, David Barajas Galindo, Andreu Simó Servat, Francisco Javier Ampudia-Blasco
{"title":"Are New Ultra-Rapid-Acting Insulins Associated with Improved Glycemic Control and Reduced Hypoglycemia in Comparison to Conventional Rapid-Acting Insulins for Individuals with Type 1 and Type 2 Diabetes? A Systematic Review and Meta-Analysis.","authors":"Rocío Villar-Taibo, Alba Galdón Sanz-Pastor, Elsa Fernández-Rubio, David Barajas Galindo, Andreu Simó Servat, Francisco Javier Ampudia-Blasco","doi":"10.1089/dia.2023.0524","DOIUrl":"10.1089/dia.2023.0524","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> This study aimed to compare efficacy and safety of ultra-rapid-acting insulin analogs (URAIs; faster aspart [FAsp], ultra-rapid lispro [URLi], and technosphere insulin [TI]) with rapid-acting insulin analogs (RAI) in individuals with type 1 (T1D) or type 2 diabetes (T2D). <b><i>Methods:</i></b> Searching for randomized control trial comparing the effects of URAI versus RAI that lasted at least 12 weeks, we initially selected 15 studies for analysis. Three studies involving TI were excluded due to a high degree of heterogeneity. The final meta-analysis included only 12 studies with either FAsp or URLi. <b><i>Results:</i></b> Mealtime URAI significantly reduced overall early 1 h postprandial glycemia in individuals with T1D (-20.230 mg/dL [95% confidence interval, 95% CI -24.040 to -16.421]; <i>P</i> < 0.001; <i>I</i><sup>2</sup> = 33.42%) and those with T2D (-9.138 mg/dL [95% CI -12.612 to -5.663]; <i>P</i> < 0.001; <i>I</i><sup>2</sup> = 0%). However, the significant reduction in 2 h postprandial glucose remained only in individuals with T1D (-17.620 mg/dL [95% CI -26.047 to -9.193]; <i>P</i> < 0.001; <i>I</i><sup>2</sup> = 65.88%). These benefits were lost when URAI was administered postmeal. At 24-26 weeks, there was no significant difference in HbA1c between groups, but at 52 weeks, a slight reduction in HbA1c with mealtime URAI was observed (-0.080% [95% CI -0.147 to -0.013]; <i>P</i> = 0.019; <i>I</i><sup>2</sup> = 0%). No difference in weight or the rate of severe or confirmed hypoglycemia was observed. Only individuals with T1D showed a small, but significant increase in early 1-h hypoglycemia with URAI (1.468 [95% CI 1.235 to 1.747]; <i>P</i> < 0.001; <i>I</i><sup>2</sup> = 0%). <b><i>Conclusion:</i></b> Mealtime URAI improves 1 and 2 h postprandial glycemic control compared to RAI without increasing hypoglycemia or weight gain.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"575-586"},"PeriodicalIF":5.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140157726","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}