Randomized Controlled Trial of Mobile Closed-Loop Control
Boris Kovatchev, Stacey M Anderson, Dan Raghinaru, Yogish C Kudva, Lori M Laffel, Carol Levy, Jordan E Pinsker, R Paul Wadwa, Bruce Buckingham, Francis J Doyle 3rd, Sue A Brown, Mei Mei Church, Vikash Dadlani, Eyal Dassau, Laya Ekhlaspour, Gregory P Forlenza, Elvira Isganaitis, David W Lam, John 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 Breton, Lori M Laffel, Elvira Isganaitis, Louise Ambler-Osborn, Emily Flint, Alan Schultz, Kenny Kim, Jordan E Pinsker, Mei Mei Church, Camille Andre, Carol 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 Messer, Cari Berget, Lindsey Towers, Bruce Buckingham, Laya Ekhlaspour, Liana Hsu, Sarah Loebner, Francis J Doyle 3rd, Eyal Dassau, John Lum, Roy W Beck, Tiffany Campos, Samantha Passman, Carlos Murphy, Nandan Patibandla, Dan Raghinaru, Craig Kollman, Boris Kovatchev, Stacey M Anderson, Dan Raghinaru, Yogish C Kudva, Lori M Laffel, Carol Levy, Jordan E Pinsker, R Paul Wadwa, Bruce Buckingham, Francis J Doyle 3rd, Sue A Brown, Mei Mei Church, Vikash Dadlani, Eyal Dassau, Laya Ekhlaspour, Gregory P Forlenza, Elvira Isganaitis, David W Lam, John 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 Breton, Lori M Laffel, Elvira Isganaitis, Louise Ambler-Osborn, Emily Flint, Alan Schultz, Kenny Kim, Jordan E Pinsker, Mei Mei Church, Camille Andre, Carol 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 Messer, Cari Berget, Lindsey Towers, Bruce Buckingham, Laya Ekhlaspour, Liana Hsu, Sarah Loebner, Francis J Doyle 3rd, Eyal Dassau, John 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.
© 2020 by the American Diabetes Association.
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Source: PubMed