Hybrid Closed Loop Using a Do-It-Yourself Artificial Pancreas System in Adults With Type 1 Diabetes

Abstract

Objective: There is increasing use of open-source artificial pancreas systems (APS) in the management of Type 1 diabetes. Our aim was to assess the safety and efficacy of the automated insulin delivery system AndroidAPS (AAPS), compared with stand-alone pump therapy in people with type 1 diabetes. The primary outcome was the difference in the percentage of time in range (TIR, 70-180 mg/dL). Secondary aims included mean sensor glucose value and percent continuous glucose monitor (CGM) time below range (TBR, <70 mg/dL). Research Design and Methods: This open-label single-center randomized crossover study (ANZCTR, Australian New Zealand clinical trial registry, ANZCTR-ACTRN12620001191987) comprised 20 participants with type 1 diabetes on established pump therapy, assigned to either stand-alone insulin pump therapy or the open-source AAPS hybrid closed-loop system for four weeks, with crossover to the alternate arm for the following four weeks. The CGM outcome parameters were measured by seven-day CGM at baseline and the final week of each four-week study arm. Results: Twenty participants were recruited (60% women), aged 45.8 ± 15.9 years, with mean diabetes duration of 23.9 ± 13.2 years, baseline glycated hemoglobin (HbA1c) 7.5% ± 0.5% (58 ± 6 mmol/mol) and mean TIR 62.3% ± 12.9%. The change in TIR from baseline for AAPS compared with stand-alone pump therapy was 18.6% (11.4-25.9), ( P < .001), TIR 76.6% ± 11.7%, 58.0% ± 15.6%, for AAPS and stand-alone pump, respectively. Time glucose <54 mg/dL was not increased (mean = −2.0%, P = .191). No serious adverse events or episodes of severe hypoglycemia were recorded. Conclusions: This clinical trial of the open-source AAPS hybrid closed-loop system performed in an at-home setting demonstrated comparable safety to stand-alone pump therapy. The glycemic outcomes of AAPS were superior with improved TIR, and there was no significant difference in TBR compared with stand-alone pump therapy.

Comparison of Control‐IQ and open‐source AndroidAPS automated insulin delivery systems in adults with type 1 diabetes: The CODIAC study

“…However, in contrast to our study, their trial compared the use of AAPS with SAPs 6,7 . Additionally, similar design was also used in other studies 5–8 . However, we believe that comparing the AID system with SAP will not provide many new insights and there is a need to focus on studies with different AID systems as these are considered the standard of care for type 1 diabetes 27,28 .…”

“…6,7 Additionally, similar design was also used in other studies. [5][6][7][8] However, we believe that comparing the AID system with SAP will not provide many new insights and there is a need to focus on studies with different AID systems as these are considered the standard of care for type 1 diabetes. 27,28 Although dramatic differences between AID systems are not generally expected, 28 our study suggests that there may be differences that can be considered clinically relevant.…”

“…These constraints make RCTs with open-source AID systems difficult to conduct in many countries, with a few exceptions. [5][6][7][8] In the Czech Republic, where this trial was performed, national regulatory authorities only approved…”

“…There is increasing evidence for the efficacy of OS‐AID systems in people with T1D 4–8 . Numerous trials have shown the superiority of both commercially available AID and OS‐AID systems compared with sensor‐augmented pumps (SAPs) 5–7,9–13 .…”

How can we reach the target of glucose control in type 1 diabetes?

“…A 13‐week RCT of 102 children ages 2–6 randomized to closed‐loop insulin‐delivery showed an increase in time in range of 70–180 mg/dL from 57% to 69%, with a 5% lower time above 250 mg/dL, an 18 mg/dL lower mean glucose and a 0.4% lower HbA1c 21 . A 4‐week crossover RCT of 20 adults showed an increase in time in range from 58% to 62%, with HbA1c mean 7.5% with standalone pump and 7.1% with closed‐loop insulin delivery 22 . In a meta‐analysis of 3 RCTs of 369 people with T1D ages 2–72, time in range increased from 57% to 70%, with particular improvement overnight, mean glucose decreasing to 173 versus 161 mg/dL from 6 am –11:59 pm , and 172 versus 147 mg/dL from midnight to 5:59 am , and with significant reduction in time <70 mg/dL from 2.2% to 1.8%; the greatest improvement occurred in those with lowest time in range 23 .…”