Glycemic Outcomes of Use of CLC Versus PLGS in Type 1 Diabetes: A Randomized Controlled Trial
Sue A. Brown, Roy W. Beck, Dan Raghinaru, Bruce A. Buckingham, Lori M. Laffel, R. Paul Wadwa, Yogish C. Kudva, Carol J. Levy, Jordan E. Pinsker, Eyal Dassau, Francis J. Doyle, Louise Ambler-Osborn, Stacey M. Anderson, Mei Mei Church, Laya Ekhlaspour, Gregory P. Forlenza, Camilla Levister, Vinaya Simha, Marc D. Breton, Craig Kollman, John W. Lum, Boris Kovatchev, Boris Kovatchev, Stacey M. Anderson, Emma Emory, Mary Voelmle, Katie Conshafter, Kim Morris, Mary Oliveri, Linda Gondor-Fredrick, Harry Mitchell, Kayla Calvo, Christian Wakeman, Marc D. Breton, Lori M. Laffel, Elvira Isganaitis, Louise Ambler-Osborn, Emily Flint, Kenny Kim, Lindsay Roethke, Jordan E. Pinsker, Mei Mei Church, Camille André, Molly Piper, Carol J. Levy, David W. Lam, Grenye O’Malley, Camilla Levister, Selassie Ogyaadu, Jessica Lovett, Yogish C. Kudva, Vinaya Simha, Vikash Dadlani, Shelly McCrady-Spitzer, Corey Reid, Kanchan Kumari, R. Paul Wadwa, Gregory P. Forlenza, G. Todd Alonso, Robert H. Slover, Emily Jost, Laurel H. Messer, Cari Berget, Lindsey Towers, Alex Rossick-Solis, Bruce A. Buckingham, Laya Ekhlaspour, Tali Jacobson, Marissa Town, Ideen Tabatabai, Jordan Keller, Evalina Salas, Francis J. Doyle, Eyal Dassau, John W. Lum, Roy W. Beck, Samantha Passman, Tiffany Campos, Dan Raghinaru, Craig Kollman, Carlos Murphy, Nandan Patibandla, Sarah Borgman, Guillermo Arreza-Rubin, Thomas L. Eggerman, Neal Green, Boris Kovatchev, Sue A. Brown, Stacey M. Anderson, Marc D. Breton, Lori M. Laffel, Jordan E. Pinsker, Carol J. Levy, Yogish C. Kudva, R. Paul Wadwa, Bruce A. Buckingham, Francis J. Doyle, Éric Renard, Claudio Cobelli, Yves Reznik
Abstract
OBJECTIVE Limited information is available about glycemic outcomes with a closed-loop control (CLC) system compared with a predictive low-glucose suspend (PLGS) system. RESEARCH DESIGN AND METHODS After 6 months of use of a CLC system in a randomized trial, 109 participants with type 1 diabetes (age range, 14–72 years; mean HbA1c, 7.1% [54 mmol/mol]) were randomly assigned to CLC (N = 54, Control-IQ) or PLGS (N = 55, Basal-IQ) groups for 3 months. The primary outcome was continuous glucose monitor (CGM)-measured time in range (TIR) for 70–180 mg/dL. Baseline CGM metrics were computed from the last 3 months of the preceding study. RESULTS All 109 participants completed the study. Mean ± SD TIR was 71.1 ± 11.2% at baseline and 67.6 ± 12.6% using intention-to-treat analysis (69.1 ± 12.2% using per-protocol analysis excluding periods of study-wide suspension of device use) over 13 weeks on CLC vs. 70.0 ± 13.6% and 60.4 ± 17.1% on PLGS (difference = 5.9%; 95% CI 3.6%, 8.3%; P < 0.001). Time >180 mg/dL was lower in the CLC group than PLGS group (difference = −6.0%; 95% CI −8.4%, −3.7%; P < 0.001) while time <54 mg/dL was similar (0.04%; 95% CI −0.05%, 0.13%; P = 0.41). HbA1c after 13 weeks was lower on CLC than PLGS (7.2% [55 mmol/mol] vs. 7.5% [56 mmol/mol], difference −0.34% [−3.7 mmol/mol]; 95% CI −0.57% [−6.2 mmol/mol], −0.11% [1.2 mmol/mol]; P = 0.0035). CONCLUSIONS Following 6 months of CLC, switching to PLGS reduced TIR and increased HbA1c toward their pre-CLC values, while hypoglycemia remained similarly reduced with both CLC and PLGS.