PLoS ONE (Jan 2021)

Safety and glycemic outcomes of do-it-yourself AndroidAPS hybrid closed-loop system in adults with type 1 diabetes.

  • Andrzej Gawrecki,
  • Dorota Zozulinska-Ziolkiewicz,
  • Magdalena A Michalak,
  • Anna Adamska,
  • Michal Michalak,
  • Urszula Frackowiak,
  • Justyna Flotynska,
  • Monika Pietrzak,
  • Szymon Czapla,
  • Bernhard Gehr,
  • Aleksandra Araszkiewicz

DOI
https://doi.org/10.1371/journal.pone.0248965
Journal volume & issue
Vol. 16, no. 4
p. e0248965

Abstract

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BackgroundThe aim of the study was to assess the safety and glycemic outcomes with the use of a Do-It-Yourself (DIY) Hybrid Closed-Loop (HCL) system based on the AndroidAPS application in type 1 diabetes (T1D).MethodsSingle-center clinical trial, with 3-week run-in and 12-week study period. DIY HCL system consisted of the Dana Diabecare RS insulin pump, Dexcom G5 continuous glucose monitoring system and AndroidAPS application. Primary outcome was safety: incidences of severe hypoglycemia, diabetic ketoacidosis, time spent in glycemia ResultsIn total 12 subjects (5 men, 7 women) were enrolled, mean age 31.3±6.7, 95%CI(27.7-34.9) years, mean diabetes duration 16.1±5.7, 95%CI(13.0-19.2) years. No episodes of severe hypoglycemia or ketoacidosis were observed. Percentage of time spent in glycemia below 54mg/dl was not increased. Average sensor glycemia was lower in the study period than baseline (141.1 ± 8.4, 95%CI(136.3-145.9) vs. 153.3 ± 17.9, 95%CI(143.2-163.4), mg/dl pConclusionsThe study revealed safety of the Do-It-Yourself HCL system AndroidAPS in adults with T1D, limited to well-controlled, highly selected and closely monitored patients. The use of AndroidAPS significantly improved HbA1c, time in range and average sensor glycemia without increasing hypoglycemia. As both patients and their medical team are gaining experience using the system over time, they improve glycemic control.Trial registrationGerman Clinical Trials Register: no. DRKS00015439; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015439.