Randomized Controlled Trial of Mobile Closed-Loop Control
Boris Kovatchev, Stacey M. Anderson, Dan Raghinaru, Yogish C. Kudva, Lori M. Laffel, Carol J. Levy, Jordan E. Pinsker, R. Paul Wadwa, Bruce A. Buckingham, Francis J. Doyle, Sue A. Brown, Mei Mei Church, Vikash Dadlani, Eyal Dassau, Laya Ekhlaspour, Gregory P. Forlenza, Elvira Isganaitis, David W. Lam, John W. Lum, Roy W. Beck, iDCL Study Group, Boris Kovatchev, Stacey M. Anderson, Sue A. Brown, Emma Emory, Mary Voelmle, Katie Conshafter, Kim Morris, Mary Oliveri, Harry Mitchell, Kayla Calvo, Christian Wakeman, Marc D. Breton, Lori M. Laffel, Elvira Isganaitis, Louise Ambler-Osborn, Emily Flint, Alan Schultz, Kenny Kim, Jordan E. Pinsker, Mei Mei Church, Camille André, Carol J. Levy, David W. Lam, Grenye O’Malley, Camilla Levister, Selassie Ogyaadu, Yogish C. Kudva, Vikash Dadlani, Vinaya Simha, Shelly McCrady-Spitzer, Corey Reid, R. Paul Wadwa, Gregory P. Forlenza, Emily Jost, Laurel H. Messer, Cari Berget, Lindsey Towers, Bruce Buckingham, Laya Ekhlaspour, Liana Hsu, Sarah E. Loebner, Francis J. Doyle, Eyal Dassau, John W. Lum, Roy W. Beck, Tiffany Campos, Samantha Passman, Carlos Murphy, Nandan Patibandla, Dan Raghinaru, Craig Kollman
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 = 65) versus SAP (n = 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 −1.7% [95% CI −2.4, −1.0]; 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 −3.0% [95% CI −6.1, 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.