Sue A. Brown, United States of America
University of Virginia Center for Diabetes TechnologyPresenter of 1 Presentation
GLYCEMIC OUTCOMES OF USE OF CLC VS PLGS IN TYPE 1 DIABETES (T1D): A RANDOMIZED, CONTROLLED TRIAL
- Sue A. Brown, United States of America
- Dan Raghinaru, United States of America
- Bruce A. Buckingham, United States of America
- Yogish C. Kudva, United States of America
- Lori Laffel, United States of America
- Carol J. Levy, United States of America
- Jordan E. Pinsker, United States of America
- R. Paul Wadwa, United States of America
- John Lum, United States of America
- Roy W. Beck, United States of America
- Boris Kovatchev, United States of America
Abstract
Background and Aims
This study compares glycemic outcomes of a closed-loop control (CLC) and a predictive-low glucose suspend (PLGS) system that use the same insulin pump and CGM.
Methods
Participants with T1D used CLC for 6 months in a multicenter trial and then were randomly assigned to CLC (Control-IQ) or PLGS (Basal-IQ) for an additional 3 months. Primary outcome was time in range (TIR, 70-180mg/dL). Baseline comparison was the last 3 months of the preceding study.
Results
109 participants (mean age 33 years, glycated hemoglobin 7.1%) were randomized to CLC (N=54) or PLGS (N=55). The mean±SD TIR in the CLC group changed from 71±11% to 68±13% and decreased in the PLGS group from 70±14% to 60±17% from baseline to 13 weeks (CLC-PLGS treatment difference of 6% [95%CI: +4,+8;p<0.001]). When excluding a ~one-month suspension of CLC use due to a device error, TIR changed from 72±11% at baseline to 69±12% at 13 weeks for the CLC group. Hyperglycemia (time >180mg/dL) was lower in the CLC group (treatment difference of -6.0% [95%CI:-8.4,-3.7;p<0.001]). There was no significant difference in hypoglycemia (time <70mg/dL) between CLC and PLGS. Glycated hemoglobin was lower in the CLC group with mean difference of -0.34% (95%CI -0.57,-0.11;p=0.0035) with CLC group 7.05% to 7.18% and PLGS group 7.06% to 7.53% from baseline to 13 weeks.
Conclusions
Following 6 months of CLC, additional 3 months of closed-loop maintained TIR and HbA1c while on PLGS these metrics rebounded towards their pre-CLC values, with hypoglycemia remaining reduced with both CLC and PLGS.