> Details

Brown, Sue A.; Beck, Roy W.; Raghinaru, Dan; Buckingham, Bruce A.; Laffel, Lori M.; Wadwa, R. Paul; Kudva, Yogish C.; Levy, Carol J.; Pinsker, Jordan E.; Dassau, Eyal; Doyle, Francis J.; Ambler-Osborn, Louise; Anderson, Stacey M.; Church, Mei Mei; Ekhlaspour, Laya; Forlenza, Gregory P.; Levister, Camilla; Simha, Vinaya; Breton, Marc D.; Kollman, Craig; Lum, John W.; Kovatchev, Boris P.; Kovatchev, Boris; Anderson, Stacey; [...]

Glycemic Outcomes of Use of CLC Versus PLGS in Type 1 Diabetes: A Randomized Controlled Trial

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  • Media type: E-Article
  • Title: Glycemic Outcomes of Use of CLC Versus PLGS in Type 1 Diabetes: A Randomized Controlled Trial
  • Contributor: Brown, Sue A.; Beck, Roy W.; Raghinaru, Dan; Buckingham, Bruce A.; Laffel, Lori M.; Wadwa, R. Paul; Kudva, Yogish C.; Levy, Carol J.; Pinsker, Jordan E.; Dassau, Eyal; Doyle, Francis J.; Ambler-Osborn, Louise; Anderson, Stacey M.; Church, Mei Mei; Ekhlaspour, Laya; Forlenza, Gregory P.; Levister, Camilla; Simha, Vinaya; Breton, Marc D.; Kollman, Craig; Lum, John W.; Kovatchev, Boris P.; Kovatchev, Boris; Anderson, Stacey; [...]
  • imprint: American Diabetes Association, 2020
  • Published in: Diabetes Care
  • Language: English
  • DOI: 10.2337/dc20-0124
  • ISSN: 0149-5992; 1935-5548
  • Keywords: Advanced and Specialized Nursing ; Endocrinology, Diabetes and Metabolism ; Internal Medicine
  • Origination:
  • Footnote:
  • Description: <jats:sec> <jats:title>OBJECTIVE</jats:title> <jats:p>Limited information is available about glycemic outcomes with a closed-loop control (CLC) system compared with a predictive low-glucose suspend (PLGS) system.</jats:p> </jats:sec> <jats:sec> <jats:title>RESEARCH DESIGN AND METHODS</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>RESULTS</jats:title> <jats:p>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 &amp;lt; 0.001). Time &amp;gt;180 mg/dL was lower in the CLC group than PLGS group (difference = −6.0%; 95% CI −8.4%, −3.7%; P &amp;lt; 0.001) while time &amp;lt;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).</jats:p> </jats:sec> <jats:sec> <jats:title>CONCLUSIONS</jats:title> <jats:p>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.</jats:p> </jats:sec>
  • Access State: Open Access