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

Author:

Nanayakkara Natalie1ORCID,Sharifi Amin12,Burren David1,Elghattis Yasser1ORCID,Jayarathna Dulari K13,Cohen Neale145

Affiliation:

1. Department of Diabetes Clinical Research, Baker Heart and Diabetes Institute, Melbourne, VIC, Australia

2. Department of Endocrinology and Diabetes, Eastern Health, Box Hill, VIC, Australia

3. Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia

4. School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia

5. School of Pharmacy, The University of Queensland, Brisbane, QLD, Australia

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.

Publisher

SAGE Publications

Subject

Biomedical Engineering,Bioengineering,Endocrinology, Diabetes and Metabolism,Internal Medicine

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