Glycemic Outcomes of Use of CLC vs PLGS in Type 1 Diabetes: A Randomized, Controlled Trial
Methods: After 6 months of use of a CLC system
in a randomized trial, 109 participants with type 1 diabetes (age range 14 to
72 years, mean HbA1c 7.1% [54 mmol/mol]) were randomly assigned to CLC (N=54,
Control-IQ) or PLGS (N=55, Basal-IQ) for 3 months. Primary outcome was
CGM-measured time in range (TIR 70-180mg/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 intent-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 versus 70.0±13.6% and 60.4±17.1% on PLGS (difference = +5.9%, 95%CI +3.6 to +8.3; P<0.001]). Time >180mg/dL was lower in the CLC group than PLGS group (difference = -6.0%, 95%CI -8.4 to -3.7, p<0.001]) while time <54 mg/dL was similar (0.04%, 95% CI -0.05% to +0.13%; P=0.41). HbA1c after 13 weeks was lower on CLC than PLGS (7.2% [55 mmol/mol] versus 7.5% [56 mmol/mol], difference -0.34% [-3.7 mmol/mol], 95% CI -0.57 [-6.2 mmol/mol] to -0.11% [1.2 mmol/mol]; P=0.0035).
Conclusion: Following 6 months of CLC, switching to PLGS reduced TIR and increased HbA1c towards their pre-CLC values while hypoglycemia remained similarly reduced with both CLC and PLGS.