医学
2型糖尿病
临床终点
糖尿病
内科学
临床试验
内分泌学
作者
Quoc Dat,Aneta Hašková,Lucie Radovnická,Judita Konečná,Eva Horová,Christopher G. Parkin,George Grunberger,Martin Prázný,Jan Šoupal
摘要
Abstract Aim To compare open‐source AndroidAPS (AAPS) and commercially available Control‐IQ (CIQ) automated insulin delivery (AID) systems in a prospective, open‐label, single‐arm clinical trial. Methods Adults with type 1 diabetes who had been using AAPS by their own decision entered the first 3‐month AAPS phase then were switched to CIQ for 3 months. The results of this treatment were compared with those after the 3‐month AAPS phase. The primary endpoint was the change in time in range (% TIR; 70‐80 mg/dL). Results Twenty‐five people with diabetes (mean age 34.32 ± 11.07 years; HbA1c 6.4% ± 3%) participated in this study. CIQ was comparable with AAPS in achieving TIR (85.72% ± 7.64% vs. 84.24% ± 8.46%; P = .12). Similarly, there were no differences in percentage time above range (> 180 and > 250 mg/dL), mean sensor glucose (130.3 ± 13.9 vs. 128.3 ± 16.9 mg/dL; P = .21) or HbA1c (6.3% ± 2.1% vs. 6.4% ± 3.1%; P = .59). Percentage time below range (< 70 and < 54 mg/dL) was significantly lower using CIQ than AAPS. Even although participants were mostly satisfied with CIQ (63.6% mostly agreed, 9.1% strongly agreed), they did not plan to switch to CIQ. Conclusions The CODIAC study is the first prospective study investigating the switch between open‐source and commercially available AID systems. CIQ and AAPS were comparable in achieving TIR. However, hypoglycaemia was significantly lower with CIQ.
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