Glycemic Outcomes of Use of CLC Versus PLGS in Type 1 Diabetes: A Randomized Controlled Trial
Author:
Brown Sue A.1, Beck Roy W.2ORCID, Raghinaru Dan2, Buckingham Bruce A.3, Laffel Lori M.4ORCID, Wadwa R. Paul5, Kudva Yogish C.6ORCID, Levy Carol J.7, Pinsker Jordan E.8ORCID, Dassau Eyal489ORCID, Doyle Francis J.9ORCID, Ambler-Osborn Louise4, Anderson Stacey M.1, Church Mei Mei8, Ekhlaspour Laya3ORCID, Forlenza Gregory P.5ORCID, Levister Camilla7, Simha Vinaya6, Breton Marc D.1ORCID, Kollman Craig2, Lum John W.2ORCID, Kovatchev Boris P.1, Kovatchev Boris, Anderson Stacey, Emory Emma, Voelmle Mary, Conshafter Katie, Morris Kim, Oliveri Mary, Gondor-Fredrick Linda, Mitchell Harry, Calvo Kayla, Wakeman Christian, Breton Marc, Laffel Lori, Isganaitis Elvira, Ambler-Osborn Louise, Flint Emily, Kim Kenny, Roethke Lindsay, Pinsker Jordan, Church Mei Mei, Andre Camille, Piper Molly, Levy Carol, Lam David, O’Malley Grenye, Levister Camilla, Ogyaadu Selassie, Lovett Jessica, Kudva Yogish C., Simha Vinaya, Dadlani Vikash, McCrady-Spitzer Shelly, Reid Corey, Kumari Kanchan, Wadwa R. Paul, Forlenza Greg, Alonso G. Todd, Slover Robert, Jost Emily, Messer Laurel, Berget Cari, Towers Lindsey, Rossick-Solis Alex, Buckingham Bruce, Ekhlaspour Laya, Jacobson Tali, Town Marissa, Tabatabai Ideen, Keller Jordan, Salas Evalina, Doyle Francis, Dassau Eyal, Lum John, Beck Roy, Passman Samantha, Campos Tiffany, Raghinaru Dan, Kollman Craig, Murphy Carlos, Patibandla Nandan, Borgman Sarah, Arreza-Rubin Guillermo, Eggerman Thomas, Green Neal, Kovatchev Boris, Brown Sue, Anderson Stacey, Breton Marc, Laffel Lori, Pinsker Jordan, Levy Carol, Kudva Yogish C., Wadwa R. Paul, Buckingham Bruce, Doyle III Francis, Renard Eric, Cobelli Claudio, Reznik Yves, Arreza-Rubin Guillermo, Lum John, Beck Roy, Janicek Robert, Gabrielson Deanna, Belle Steven H., Castle Jessica, Green Jennifer, Legault Laurent, Willi Steven M., Wysham Carol, Eggerman Thomas,
Affiliation:
1. Division of Endocrinology and Center for Diabetes Technology, University of Virginia, Charlottesville, VA 2. Jaeb Center for Health Research, Tampa, FL 3. Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA 4. Research Division, Joslin Diabetes Center, Harvard Medical School, Boston, MA 5. Barbara Davis Center for Diabetes, Anschutz Medical Campus, University of Colorado, Aurora, CO 6. Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN 7. Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York City, NY 8. Sansum Diabetes Research Institute, Santa Barbara, CA 9. Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA
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.
Funder
National Institute of Diabetes and Digestive and Kidney Diseases
Publisher
American Diabetes Association
Subject
Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine
Cited by
36 articles.
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