The International Diabetes Closed-Loop Study: Testing Artificial Pancreas Component Interoperability

Stacey M. Anderson, Eyal Dassau, Dan Raghinaru, John Lum, Sue A. Brown, Jordan E. Pinsker, Mei Mei Church, Carol Levy, David Lam, Yogish C. Kudva, Bruce Buckingham, Gregory P. Forlenza, R. Paul Wadwa, Lori Laffel, Francis J. Doyle, J. Hans Devries, Eric Renard, Claudio Cobelli, Federico Boscari, Simone Del FaveroBoris P. Kovatchev

Research output: Contribution to journalArticle

5 Scopus citations

Abstract

Background: Use of artificial pancreas (AP) requires seamless interaction of device components, such as continuous glucose monitor (CGM), insulin pump, and control algorithm. Mobile AP configurations also include a smartphone as computational hub and gateway to cloud applications (e.g., remote monitoring and data review and analysis). This International Diabetes Closed-Loop study was designed to demonstrate and evaluate the operation of the inControl AP using different CGMs and pump modalities without changes to the user interface, user experience, and underlying controller. Methods: Forty-three patients with type 1 diabetes (T1D) were enrolled at 10 clinical centers (7 United States, 3 Europe) and 41 were included in the analyses (39% female, >95% non-Hispanic white, median T1D duration 16 years, median HbA1c 7.4%). Two CGMs and two insulin pumps were tested by different study participants/sites using the same system hub (a smartphone) during 2 weeks of in-home use. Results: The major difference between the system components was the stability of their wireless connections with the smartphone. The two sensors achieved similar rates of connectivity as measured by percentage time in closed loop (75% and 75%); however, the two pumps had markedly different closed-loop adherence (66% vs. 87%). When connected, all system configurations achieved similar glycemic outcomes on AP control (73% [mean] time in range: 70-180 mg/dL, and 1.7% [median] time <70 mg/dL). Conclusions: CGMs and insulin pumps can be interchangeable in the same Mobile AP system, as long as these devices achieve certain levels of reliability and wireless connection stability.

Original languageEnglish (US)
Pages (from-to)73-80
Number of pages8
JournalDiabetes Technology and Therapeutics
Volume21
Issue number2
DOIs
StatePublished - Feb 2019

Keywords

  • Continuous glucose monitor use
  • Insulin pump use
  • International Diabetes Closed-Loop Study

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology
  • Medical Laboratory Technology

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    Anderson, S. M., Dassau, E., Raghinaru, D., Lum, J., Brown, S. A., Pinsker, J. E., Church, M. M., Levy, C., Lam, D., Kudva, Y. C., Buckingham, B., Forlenza, G. P., Wadwa, R. P., Laffel, L., Doyle, F. J., Hans Devries, J., Renard, E., Cobelli, C., Boscari, F., ... Kovatchev, B. P. (2019). The International Diabetes Closed-Loop Study: Testing Artificial Pancreas Component Interoperability. Diabetes Technology and Therapeutics, 21(2), 73-80. https://doi.org/10.1089/dia.2018.0308