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1صورة
المؤلفون: Rose A. Gubitosi-Klug (9127188), Barbara H. Braffett (9127186), Ionut Bebu (516571), Mary L. Johnson (6254417), Kaleigh Farrell (11853160), David Kenny (3505283), Victoria R. Trapani (11853161), Lynne Meadema-Mayer (11853162), Elsayed Z. Soliman (7743179), Rodica Pop-Busui (812593), John M. Lachin (9651430), Richard M. Bergenstal (6254405), William V. Tamborlane (6867473), the DCCT/EDIC Research Group (10048456)
مصطلحات موضوعية: Clinical Sciences not elsewhere classified, Type 1 Diabetes, CGM, Hypoglycemia, Insulin Delivery, Hyperglycemia
الوصف: Objective : We evaluated blinded continuous glucose monitoring (CGM) profiles in a subset of adults with type 1 diabetes from the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study to characterize the frequency of glycemic excursions and contributing factors. Research Design and Methods : CGM-derived metrics were compared for daytime and nighttime periods using blinded CGM for a minimum of 6.5 days (average 11.9 days) and correlated with HbA1c levels, routine use of diabetes devices, and other characteristics in 765 participants. Results : Participants were 58.9±6.5 years of age with diabetes duration 36.8±4.9 years and HbA1c 7.8±1.2%; 58% used insulin pumps and 27% used personal, unblinded CGM. Compared to daytime, nighttime mean sensor glucose was lower, % time in range 70-180 mg/dL (TIR) was similar and hypoglycemia more common. Over the entire recording period, only 9% of the 765 participants achieved >70% TIR and only 28% achieved <1% of observations <54 mg/dL. Indeed, participants with the highest percentage of hypoglycemia had the lowest HbA1c levels. However, use of insulin pumps and CGM decreased the % time <54 mg/dL. Conclusions : In adults with long-standing type 1 diabetes, short-term blinded CGM profiles revealed frequent clinically-significant hypoglycemia (<54 mg/dL) during the night and more time in hyperglycemia during the day. The small subset of participants using routine CGM and insulin pumps had fewer hypoglycemic and hyperglycemic excursions and lower HbA1c levels. Thus, strategies to lower meal-stimulated hyperglycemia during the day and prevent hypoglycemia at night are relevant clinical goals in older type 1 diabetes patients.
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2صورة
المؤلفون: Grazia Aleppo (8550433), Roy W. Beck (5003147), Ryan Bailey (617365), Katrina J. Ruedy (9661846), Peter Calhoun (8996351), Anne L. Peters (3196224), Rodica Pop-Busui (812593), Athena Philis-Tsimikas (6493390), Shichun Bao (11422340), Guillermo Umpierrez (5026829), Georgia Davis (77599), Davida Kruger (6867452), Anuj Bhargava (1467514), Laura Young (11422341), Janet B. McGill (5340071), Thomas Martens (794066), Quang T. Nguyen (1747000), Ian Orozco (11422343), William Biggs (3854914), K. Jean Lucas (11422344), William H. Polonsky (5701483), John B. Buse (7450016), David Price (18505), Richard M. Bergenstal (6254405), the MOBILE Study Group (11422347)
مصطلحات موضوعية: Clinical Sciences not elsewhere classified, Type 2 Diabetes, A1c Target, Adult(s), Continuous Glucose Monitoring (CGM), Continuous Glucose Monitoring System (CGMS), Continuous Glucose Sensing
الوصف: Objective: To explore the effect of discontinuing continuous glucose monitoring (CGM) after 8 months of CGM use in adults with type 2 diabetes treated with basal without bolus insulin. Research Design and Methods: Multi-center trial with an initial randomization to either real-time CGM or blood glucose monitoring (BGM) for 8 months, followed by 6 months in which the BGM Group continued to use BGM (N=57) and the CGM Group was re-randomized either to continue CGM (N=53) or discontinue CGM with resumption of BGM for glucose monitoring (N=53). Results: In the group that discontinued CGM, mean time in range 70-180 mg/dL (TIR), which improved from 38% prior to initiating CGM to 62% after 8 months of CGM, decreased after discontinuing CGM to 50% at 14 months (mean change from 8 to 14 months = -12%, 95% CI -21% to -3%, P=0.01). In the group continuing CGM, there was little change in TIR from 8 to 14 months (baseline 44%, 8 months 56%, 14 months 57%; mean change 8 to 14 months = 1%, 95% CI -11% to 12%, P=0.89). Comparing the two groups at 14 months, the adjusted treatment group difference in mean TIR was -6% (95% CI -16% to 4%, P=0.20). Conclusions: In adults with type 2 diabetes treated with basal insulin who had been using real-time CGM for 8 months, discontinuing CGM resulted in a loss of about half of the initial gain in TIR that had been achieved during CGM use.
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3صورة
المؤلفون: Sue A. Brown (8795528), Gregory P. Forlenza (8795552), Bruce W. Bode (5158688), Jordan E. Pinsker (8795539), Carol J. Levy (8166732), Amy B. Criego (10653049), David W. Hansen (10653052), Irl B. Hirsch (8550431), Anders L. Carlson (6254414), Richard M. Bergenstal (6254405), Jennifer L. Sherr (8461839), Sanjeev N. Mehta (10653055), Lori M. Laffel (8795533), Viral N. Shah (5027201), Anuj Bhargava (1467514), Ruth S. Weinstock (6867449), Sarah A. MacLeish (9568757), Daniel J. DeSalvo (9568712), Thomas C. Jones (2015287), Grazia Aleppo (8550433), Bruce A. Buckingham (7333196), Trang T. Ly (7333175), the Omnipod 5 Research Group (10653059)
مصطلحات موضوعية: Clinical Sciences not elsewhere classified, Automated Insulin Delivery, Insulin Pump, Childhood Diabetes, Technology and Diabetes, Medical Devices, Closed Loop Insulin Delivery, Clinical Outcomes, Multicenter Trials, Clinical Trial
الوصف: Objective: Advances in diabetes technology have transformed the treatment paradigm for type 1 diabetes, yet the burden of disease is significant. We report on a pivotal, safety study of the first tubeless, on-body automated insulin delivery system with customizable glycemic targets. Research Design and Methods: This single-arm, multicenter, prospective study enrolled 112 children (6-13.9 years) and 129 adults (14-70 years). A two-week standard therapy phase (usual insulin regimen) was followed by 3 months of automated insulin delivery. Primary safety outcomes were incidence of severe hypoglycemia and diabetic ketoacidosis. Primary effectiveness outcomes were change in HbA1c and percent time in sensor glucose range 70-180mg/dL. Results: 235 participants (98% of enrolled: 111 children, 124 adults) completed the study. HbA1c was significantly reduced in children by 0.71% (7.8mmol/mol) (mean±standard deviation: 7.67±0.95% to 6.99±0.63%, 60±10.4mmol/mol to 53±6.9mmol/mol, p <0.0001) and in adults by 0.38% (4.2mmol/mol) (7.16±0.86% to 6.78±0.68%, 55±9.4mmol/mol to 51±7.4mmol/mol, p <0.0001). Time in range was improved from standard therapy by 15.6±11.5% or 3.7 hours/day in children and 9.3±11.8% or 2.2 hours/day in adults (both p <0.0001). This was accomplished with a reduction in time in hypoglycemia <70mg/dL among adults (median (interquartile range): 2.00% (0.63, 4.06) to 1.09% (0.46, 1.75), p <0.0001), while this parameter remained the same in children. There were 3 severe hypoglycemia events not attributable to automated insulin delivery malfunction and 1 diabetic ketoacidosis event from an infusion site failure. Conclusions: This tubeless automated insulin delivery system was safe, and allowed participants to significantly improve HbA1c levels and time in target glucose range with a very low occurrence of hypoglycemia.
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4صورة
المؤلفون: Harpreet S. Bajaj (9250266), Richard M. Bergenstal (6254405), Andreas Christoffersen (10151925), Melanie J. Davies (7155500), Amoolya Gowda (10151928), Joakim Isendahl (292774), Ildiko Lingvay (6805151), Peter A. Senior (5954285), Robert J. Silver (10151929), Roberto Trevisan (499060), Julio Rosenstock (4963318)
مصطلحات موضوعية: Clinical Sciences not elsewhere classified, Basal Insulins, Basal Therapy, Efficacy, Glycemic Control, Randomized Controlled Trial, Phase 2 Studies, Safety, Continuous Glucose Monitoring
الوصف: OBJECTIVE Insulin icodec (icodec) is a novel once-weekly basal insulin analog. This trial investigated two approaches for switching to icodec versus once-daily insulin glargine U100 (IGlar U100) in people with type 2 diabetes receiving daily basal insulin and ≥1 oral glucose-lowering medication. RESEARCH DESIGN AND METHODS This multicenter, open-label, treat-to-target phase 2 trial randomized (1:1:1) eligible basal-insulin-treated (total daily dose 10–50 U) people with type 2 diabetes (HbA 1c 7.0–10.0% [53.0–13.3 mmol/mo]) to icodec with an initial 100% loading dose (where only the first dose was doubled; icodec LD), icodec with no loading dose (icodec NLD) or IGlar U100 for 16 weeks. Primary endpoint was percent time in range (TIR; 3.9–10.0 mmol/L [70–180 mg/dL]) during weeks 15 and 16, measured using continuous glucose monitoring. Key secondary endpoints included HbA 1c , adverse events (AEs) and hypoglycemia. RESULTS Estimated mean TIR during weeks 15 and 16 was 72.9% (icodec LD; n = 54), 66.0% (icodec NLD; n = 50) and 65.0% (IGlar U100; n = 50), with a statistically significant difference favoring icodec LD versus IGlar U100 (7.9%-points, 95% CI 1.8 to 13.9%). Mean HbA 1c reduced from 7.9% (62.8 mmol/mol) at baseline to 7.1% ([54.4 mmol/mol] icodec LD) and 7.4% ([57.6 mmol/mol] icodec NLD and IGlar U100); incidences and rates of AEs and hypoglycemic episodes were comparable. CONCLUSIONS Switching from daily basal insulin to once-weekly icodec was well tolerated and provided effective glycemic control. Loading dose use when switching to once-weekly icodec significantly increased percent TIR during weeks 15 and 16 versus once-daily IGlar U100, without increasing hypoglycemia risk.
