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

2020

https://researcherprofiles.org/profile/274449580

32471910

Brown SA, Beck RW, Raghinaru D, Buckingham BA, Laffel LM, Wadwa RP, Kudva YC, Levy CJ, Pinsker JE, Dassau E, Doyle FJ, Ambler-Osborn L, Anderson SM, Church MM, Ekhlaspour L, Forlenza GP, Levister C, Simha V, Breton MD, Kollman C, Lum JW, Kovatchev BP, iDCL Trial Research Group

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 HbA, 7.1% [54 mmol/mol]) were randomly assigned to CLC ( = 54, Control-IQ) or PLGS ( = 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%; < 0.001). Time >180 mg/dL was lower in the CLC group than PLGS group (difference = -6.0%; 95% CI -8.4%, -3.7%; < 0.001) while time <54 mg/dL was similar (0.04%; 95% CI -0.05%, 0.13%; = 0.41). HbA 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]; = 0.0035).

CONCLUSIONS

Following 6 months of CLC, switching to PLGS reduced TIR and increased HbA toward their pre-CLC values, while hypoglycemia remained similarly reduced with both CLC and PLGS.

Journal Issue

Volume 43 of Issue 8