التفاصيل البيبلوغرافية
| العنوان: |
Improved Glycemia with Hybrid Closed-Loop (HCL) Versus Continuous Subcutaneous Insulin Infusion (CSII) Therapy: Results from a Randomized Controlled Trial. |
| المؤلفون: |
Garg, Satish K.1 (AUTHOR) satish.garg@cuanschutz.edu, Grunberger, George2 (AUTHOR), Weinstock, Ruth3 (AUTHOR), Lawson, Margaret L.4 (AUTHOR), Hirsch, Irl B.5 (AUTHOR), DiMeglio, Linda A.6 (AUTHOR), Pop-Busui, Rodica7 (AUTHOR), Philis-Tsimikas, Athena8 (AUTHOR), Kipnes, Mark9 (AUTHOR), Liljenquist, David R.10 (AUTHOR), Brazg, Ronald L.11 (AUTHOR), Kudva, Yogish C.12 (AUTHOR), Buckingham, Bruce A.13 (AUTHOR), McGill, Janet B.14 (AUTHOR), Carlson, Anders L.15 (AUTHOR), Criego, Amy B.15 (AUTHOR), Christiansen, Mark P.16 (AUTHOR), Kaiserman, Kevin B.17 (AUTHOR), Griffin, Kurt J.18 (AUTHOR), Forlenza, Greg P.19 (AUTHOR) |
| المصدر: |
Diabetes Technology & Therapeutics. Jan2023, Vol. 25 Issue 1, p1-12. 12p. |
| مصطلحات موضوعية: |
*SUBCUTANEOUS infusions, *INFUSION therapy, *INSULIN therapy, *RANDOMIZED controlled trials, *TYPE 1 diabetes |
| مستخلص: |
Objective: To evaluate safety and effectiveness of MiniMed™ 670G hybrid closed loop in comparison with continuous subcutaneous insulin infusion (CSII) therapy for six months, in persons with type 1 diabetes (T1D).Methods: Adults (aged 18-80 years), adolescents, and children (aged 2-17 years) with T1D who were using CSII therapy were enrolled and randomized (1:1) to six months of HCL intervention (N=151, mean age of 39.9±19.8 years) or CSII control (N=151, 35.7±18.4 years) without continuous glucose monitoring. Primary effectiveness endpoints included change in A1C for Group 1 (baseline A1C >8.0%), from baseline to the end of study, and difference in the end of study percentage of time spent below 70 mg/dL (%TBR<70 mg/dL) for Group 2 (baseline A1C ≤8.0%), to show superiority of HCL intervention versus control. Secondary effectiveness endpoints were change in A1C and %TBR<70 mg/dL for Group 2 and Group 1, respectively, to show non-inferiority of HCL intervention versus control. Primary safety endpoints were rates of severe hypoglycemia and diabetic ketoacidosis (DKA).Results: Change in A1C and difference in %TBR<70 mg/dL for the overall group were significantly improved, in favor of HCL intervention. In addition, a significant mean (95% CI) change in A1C was observed for both Group 1 (-0.8% [-1.1%,-0.4%], p<0.0001) and Group 2 (-0.3% [-0.5%,-0.1%], p<0.0001), in favor of HCL intervention. The same was observed for difference in %TBR<70 mg/dL for Group 1 (-2.2% [-3.6%,-0.9%]) and Group 2 (-4.9% [-6.3%,-3.6%]) (p<0.0001 for both). There was one DKA event during run-in and six severe hypoglycemic events: two during run-in and four during study (HCL: N=0 and CSII: N=4 [6.08 per 100 patient-years]).Conclusions: This RCT demonstrate that the MiniMed 670G system safely and significantly improved A1C and %TBR<70 mg/dL with HCL intervention compared with CSII control in persons with T1D, irrespective of baseline A1C level. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
Academic Search Index |
