TY - JOUR
T1 - The International Diabetes Closed-Loop Study
T2 - Testing Artificial Pancreas Component Interoperability
AU - Anderson, Stacey M.
AU - Dassau, Eyal
AU - Raghinaru, Dan
AU - Lum, John
AU - Brown, Sue A.
AU - Pinsker, Jordan E.
AU - Church, Mei Mei
AU - Levy, Carol
AU - Lam, David
AU - Kudva, Yogish C.
AU - Buckingham, Bruce
AU - Forlenza, Gregory P.
AU - Wadwa, R. Paul
AU - Laffel, Lori
AU - Doyle, Francis J.
AU - Hans Devries, J.
AU - Renard, Eric
AU - Cobelli, Claudio
AU - Boscari, Federico
AU - Del Favero, Simone
AU - Kovatchev, Boris P.
N1 - Funding Information:
S.M.A. reports grants from National Institutes of Health during the conduct of the study and grants from Medtronic and personal fees from Senseonics outside the submitted work. E.D., D.R., J.L., M.M.C., D.L., B.B., F.J.D., and F.B. have nothing to disclose. SAB reports non-financial support to the University of Virginia from Roche Diabetes, Dexcom, and Tandem Diabetes Care. J.E.P. reports personal fees, nonfinancial support, and other support from Tandem Diabetes Care, nonfinancial support and other support from In-sulet Corporation, other support from Bigfoot Biomedical, nonfinancial support from Animas, Lifescan, Roche, As-censia, and Dexcom outside the submitted work. C.L. reports grants and personal fees from NovoNordisk, personal fees from Medtronic, grants from Senseonics, and supplies for research from Dexcom and TypeZero during conduct of study. Y.C.K. reports nonfinancial support from Dexcom, Roche Diabetes, Tandem, and grants from Medtronic outside the submitted work. Y.C.K. has a patent Estimation of Insulin Sensitivity from CGM and Subcutaneous Insulin Delivery in T1D licensed. G.P.F. reports grants and personal fees from Medtronic, Dexcom, and Tandem; grants from Abbott, In-sulet, TypeZero, and Beta Bionics during the conduct of the study. R.P.W. reports personal fees from Eli Lilly, grants, personal fees and nonfinancial support from Dexcom, grants and personal fees from Novo Nordisk, and grants from Bigfoot Biomedical outside the submitted work. L.L. reports grants from NIH during conduct of the study. J.H.D. reports nonfinancial support from Roche, Dexcom, and Tandem during the conduct of the study and nonfinancial support from Abbott, grants and nonfinancial support from Dexcom, nonfinancial support from Medtronic, personal fees from Roche Diabetes, personal fees from Senseonics, and personal fees from Zealand outside the submitted work. E.R. reports personal fees from Abbott, Eli-Lilly, Insulet, NovoNordisk, Roche, and Sanofi; nonfinancial support from Dexcom and Tandem during the conduct of study. C.C. reports nonfinancial support from Roche, Senseonics; personal fees from Novo-Nordisk outside the submitted work. C.C. also has a patent B9 PCT/US2008/082063 issued and a patent PCT/IT2012/000083 issued. S.D.F. reports nonfinancial support from Dexcom and Roche during the conduct of the study; grants from Dexcom outside the submitted work. B.P.K. reports research support handled by the University of Virginia: Dexcom, Roche, Sanofi, Tandem; patent royalties handled by the University of Virginia: Johnson & Johnson, Sanofi; Consultant: Sanofi, Tandem; Speaker’s Bureau: Sanofi, Dexcom.
Funding Information:
Roche Diabetes Care supplied insulin pumps and blood glucose testing supplies for this study. The authors thank the study participants. A listing of the participants study sites, investigators, and coordinators is included as follows: IDCL Study Site and Personnel—Charlottesville, VA Center for Diabetes Technology, University of Virginia Health System: Stacey Anderson (PI), Boris Kovatchev (I), Sue Brown (I), Linda Gonder-Frederick (I), Emma Emory (C), Laura Kollar (C), and Charlotte Barnett (T); Boston, MA Joslin Diabetes Center: Lori Laffel (PI), Elvira Isganaitis (I), Sanjeev Mehta (I), and Louise Ambler-Osborn (C); Santa Barbara, CA Sansum Diabetes Research Institute: Jordan Pinsker (PI), Mei Mei Church (I), Tyler Jean (C), and Camille Andre (C); New York, NY Mt. Sinai School of Medicine: Carol Levy (PI), Camilla Levister (I), David Lam (I), Georgia Kulina (I), Hanna Lee (I), Anna Aluf (I), Robert Rapaport (I), Elizabeth Burtman (I), and Selassie Ogyaadu (C); Rochester, MN St. Mary’s Hospital, Endocrine Unit, Mayo Clinic: Yogish Kudva (PI), Ananda Basu (I), Seema Kumar (I), Aida Lteif (I), Shelly McCrady-Spitzer (C), and V. Dadlani, (C); Aurora, CO Barbara Davis Center for Diabetes, University of Colorado: Paul Wadwa (PI), Gregory Forlenza (I), Todd Alonso (I), Robert Slover (I), and Emily Jost (C); Palo Alto, CA, Stanford University, Pediatric Endocrinology and Diabetes: Bruce Buckingham (PI), David Maahs (I), Paula Clinton (C), Tatiana Marcal (C), and Jasmine Doiev (C); Montpellier, France Montpellier University Hospital: Eric Renard (PI), Anne Farret (I), and Jerome Place (C); Padova, Italy University of Padova, Department of Engineering: Claudio Cobelli (PI), Simone Del Favero (I, C), Roberto Visentin (I), and Simone Faccioli; Padova, Italy University of Padova, Department of Medicine: Daniela Bruttomesso (I), Angelo Avogaro (I), Federico Boscari (I), Silvia Galasso (I), and Valeria Vallone (I); Amsterdam, Netherlands University of Amsterdam, Academic Medical Center: J Hans DeVries (PI), Jort Kropff (I), and Nathalie Masurel (C); Cambridge, MA John A. Paulson School of Engineering and Applied Sciences, Harvard University: Eyal Dassau (I) and Francis Doyle (I). Funding: The iDCL interoperability study was supported by NIH/NIDDK Grant UC4 DK 108483.
Publisher Copyright:
© 2019, Mary Ann Liebert, Inc., publishers.
PY - 2019/2
Y1 - 2019/2
N2 - 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.
AB - 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.
KW - Continuous glucose monitor use
KW - Insulin pump use
KW - International Diabetes Closed-Loop Study
UR - http://www.scopus.com/inward/record.url?scp=85060912327&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85060912327&partnerID=8YFLogxK
U2 - 10.1089/dia.2018.0308
DO - 10.1089/dia.2018.0308
M3 - Article
C2 - 30649925
AN - SCOPUS:85060912327
VL - 21
SP - 73
EP - 80
JO - Diabetes Technology and Therapeutics
JF - Diabetes Technology and Therapeutics
SN - 1520-9156
IS - 2
ER -