@article{5b4cf935431f473e8e8ccba744a25f14,
title = "Randomized controlled trial of mobile closed-loop control",
abstract = "OBJECTIVE Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system. RESEARCH DESIGN AND METHODS This protocol, NCT02985866, is a 3-month parallel-group, multicenter, randomized unblinded trial designed to compare mobile CLC with sensor-augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ‡14 years, and baseline HbA1c <10.5% (91 mmol/mol). The study was designed to assess two coprimary outcomes: superiority of CLC over SAP in continuous glucose monitor (CGM)–measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L. RESULTS Between November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC (n 5 65) versus SAP (n 5 62); 125 participants completed the study. CGM time below 3.9 mmol/L was 5.0% at baseline and 2.4% during follow-up in the CLC group vs. 4.7% and 4.0%, respectively, in the SAP group (mean difference 21.7% [95% CI 22.4, 21.0]; P < 0.0001 for superiority). CGM time above 10 mmol/L was 40% at baseline and 34% during follow-up in the CLC group vs. 43% and 39%, respectively, in the SAP group (mean difference 23.0% [95% CI 26.1, 0.1]; P < 0.0001 for noninferiority). One severe hypoglycemic event occurred in the CLC group, which was unrelated to the study device. CONCLUSIONS In meeting its coprimary end points, superiority of CLC over SAP in CGM-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L, the study has demonstrated that mobile CLC is feasible and could offer certain usability advantages over embedded systems, provided the connectivity between system components is stable.",
author = "{iDCL Study Group} and Boris Kovatchev and Anderson, {Stacey M.} and Dan Raghinaru and Kudva, {Yogish C.} and Laffel, {Lori M.} and Carol Levy and Pinsker, {Jordan E.} and {Paul Wadwa}, R. and Bruce Buckingham and Doyle, {Francis J.} and Brown, {Sue A.} and Church, {Mei Mei} and Vikash Dadlani and Eyal Dassau and Laya Ekhlaspour and Forlenza, {Gregory P.} and Elvira Isganaitis and Lam, {David W.} and John Lum and Beck, {Roy W.}",
note = "Funding Information: provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grant UC4-DK-108483. Material support was provided by TypeZero Technologies (CLC and Cloud monitoring systems), Dexcom (CGM sensors), Roche Diabetes Care (insulin pumps), and Ascensia Diabetes Care (blood glucose meters and test strips). B.K. reports patents and patent applications related to diabetes technology managed by the University of Virginia Licensing and Ventures group; research support managed by the University of Virginia from Dexcom, Roche Diagnostics, Sanofi, and Tandem Diabetes Care; and speaking engagement, advisory panel, and consultant fees from Dexcom, Sanofi, and Tandem Diabetes Care. During this study, B.K. was a shareholder in TypeZero Technologies; this relationship expired in August 2018. S.M.A. reports research support from Medtronic. Y.C.K. reports grants from NIDDK during the conduct of the Funding Information: reports grants from Senseonics Eversense outside the submitted work. J.L. reports grants from NIDDK, JDRF, and the Helmsley Charitable Trust during the conduct of the study and other support from Animas Corporation, Bigfoot Biomedical, Tandem Diabetes Care, and Eli Lilly outside the submitted work. R.W.B. reports grants from NIH and nonfinancial support from Dexcom, Roche, and Ascensia during the conduct of the study and other support from Insulet, Bigfoot Biomedical, and Eli Lilly and grants and nonfinancialsupportfromTandemDiabetesCare and Dexcom outside the submitted work. No other potential conflicts of interest relevant to this article were reported. Funding Information: Funding was provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grant UC4-DK-108483. Material support was provided by TypeZero Technologies (CLC and Cloud monitoring systems), Dexcom (CGM sensors), Roche Diabetes Care (insulin pumps), and Ascensia Diabetes Care (blood glucose meters and test strips). B.K. reports patents and patent applications related to diabetes technology managed by the University of Virginia Licensing and Ventures group; research support managed by the University of Virginia from Dexcom, Roche Diagnostics, Sanofi, and Tandem Diabetes Care; and speaking engagement, advisory panel, and consultant fees from Dexcom, Sanofi, and Tandem Diabetes Care. During this study, B.K. was a shareholder in TypeZero Technologies; this relationship expired in August 2018. S.M.A. reports research support from Medtronic. Y.C.K. reports grants from NIDDK during the conduct of the study and nonfinancial support from Dexcom, Tandem Diabetes Care, and Roche Diabetes Care and other support from Medtronic Diabetes outside the submitted work. In addition, Y.C.K. has a patent issued on “Estimation of insulin sensitivity from CGM and subcutaneous insulin delivery in type 1 diabetes.” L.M.L. reports grants from NIH, NIDDK, during the conduct of the study and personal fees from Eli Lilly, Novo Nordisk, Sanofi, Merck, AstraZeneca, Boehringer Ingelheim, Roche, Insulet, Dexcom, Convatec, and Insulinogic outside the submitted work. C.L. reports grants from Abbott Diabetes, grants from Senseonics paid to her institution, nonfinancial support from Dexcom, service as a consultant for Sanofi, and other support from Novo Nordisk outside the submitted work. J.E.P. reports grants and personal fees from Tandem Diabetes Care, grants from Medtronic and Eli Lilly, grants and nonfinancial support from Insulet, and nonfinancial support from Dexcom outside the submitted work. R.P.W. reports grants and personal fees from Dexcom and grants from Tandem Diabetes Care outside the submitted work. B.B. reports personal fees and other support from Tandem Diabetes Care during the conduct of the study; grants, personal fees, and nonfinancial support from Medtronic Diabetes; grants and personal fees from Convatec and Insulet; and nonfinancial support from Dexcom. In addition, B.B. has a patent pending on a hypoglycemia prediction algorithm. F.J.D. reports grants from NIH; personal fees, nonfinancial support, and other support from Roche; and nonfinancial and other support from Dexcom during the conduct of the study. He also reports grants from NIH, JDRF, and the Helmsley Charitable Trust; nonfinancial and other support from Tandem Diabetes Care, Insulet, LifeScan, Dexcom, and Xeris; and personal fees, nonfinancial support, and other support from Roche outside the submitted work. In addition, F.J.D. has U.S. Patents 9,984,773, 9,907,515, 9,700,708, and 8,762,070 with royalties paid; U.S. Provisional Patent Application 14/734,994 pending; and U.S. Provisional Patent Applications 61/903,965, 61/751,942, and 61/751,941 with royalties paid. S.A.B. reports grants and nonfinancial support from Tandem Diabetes Care and nonfinancial support from Roche Diagnostics and Dexcom outside the submitted work. E.D. reports grants from NIH; personal fees, nonfinancial support, and other support from Roche; and nonfinancial and other support from Dexcom during the conduct of the study. He also reports grants from NIH, JDRF, and the Helmsley Charitable Trust; nonfinancial and other support from Tandem Diabetes Care, Life-scan, Dexcom, and Xeris; personal fees, nonfinancial support, and other support from Insulet and Roche; and personal fees from Eli Lily outside the submitted work. In addition, E.D. has U.S. Patents 9,984,773, 9,907,515, 9,700,708, and 8,762,070 with royalties paid; U.S. Provisional Patent Application 14/734,994 pending; and U.S. Provisional Patent Applications 61/903,965, 61/751,942, and 61/751,941 with royalties paid. G.P.F. reports grants and personal fees from Medtronic, Dexcom, Abbott, Tandem Diabetes Care, and Insulet outside the submitted work. D.W.L. reports grants from Senseonics Eversense outside the submitted work. J.L. reports grants from NIDDK, JDRF, and the Helmsley Charitable Trust during the conduct of the study and other support from Animas Corporation, Bigfoot Biomedical, Tandem Diabetes Care, and Eli Lilly outside the submitted work. R.W.B. reports grants from NIH and nonfinancial support from Dexcom, Roche, and Ascensia during the conduct of the study and other support from Insulet, Bigfoot Biomedical, and Eli Lilly and grants and nonfinancial support from T and em Diabetes Care and Dexcom outside the submitted work. No other potential conflicts of interest relevant to this article were reported. Publisher Copyright: {\textcopyright} 2020 by the American Diabetes Association.",
year = "2020",
month = mar,
day = "1",
doi = "10.2337/dc19-1310",
language = "English (US)",
volume = "43",
pages = "607--615",
journal = "Diabetes Care",
issn = "1935-5548",
publisher = "American Diabetes Association Inc.",
number = "3",
}