Visual Abstract
Background: In our published trial in 120 adults with type 1 diabetes (T1D), allocation to hybrid closed loop (HCL) increased Continuous Glucose Monitoring (CGM) Time in Range ((TIR), 70-180mg/dL) by 15 percentage points vs. user-determined insulin dosing. Recommended TIR is >70%.
Objective: To examine associations of pre-randomization factors with trial-end 3-weeks masked CGM TIR in adults with T1D treated with 6-months HCL.
Methods: MDI and non-HCL pump users (no CGM) were randomized 1:1 to 26-weeks HCL (Medtronic 670G) or ongoing standard care. Analyses are on HCL group (n=55): Pre-randomization factors are related to trial-end masked CGM TIR >70 vs. ≤70% and to TIR as a continuous variable. Continuous variables are compared by t-test and binary variables by chi-square with significance at P<0.05.
Results: Table: Pre-randomization characteristics by trial-end TIR > vs. ≤70%. Significant univariate correlations between trial-end TIR as a continuous variable existed for pre-randomization factors: HbA1c (at enrolment and randomization), 1,5-anhydroglucitol, CGM metrics: %TIR (70-180mg/dl), %TIR (70-140mg/dl), mean glucose, SD glucose.
Conclusions: The main factor associated with HCL users achieving higher TIR was pre-randomization glycemia. TIR was not associated with age, sex, prior pump use and socioeconomic status.
A. Jenkins: Advisory Panel; Self; Abbott Diabetes, Sanofi-Aventis, Other Relationship; Self; Amgen Inc., Research Support; Self; Abbott, International Diabetes Federation, JDRF, Medtronic, Mylan N. V. N. Cohen: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Research Support; Self; Ypsomed Group, Speaker’s Bureau; Self; Novo Nordisk. P. G. Colman: None. E. A. Davis: None. J. Holmes-walker: None. A. C. Keech: None. R. Macisaac: Advisory Panel; Self; AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Novo Nordisk, Servier Laboratories, Speaker’s Bureau; Self; Boehringer Ingelheim International GmbH, Novo Nordisk. C. M. Sims: Stock/Shareholder; Self; Medtronic. V. Sundararajan: None. S. Trawley: None. G. M. Ward: None. A. S. Januszewski: None. T. Jones: None. D. N. O’neal: Advisory Panel; Self; Abbott Diabetes, Medtronic, Sanofi, Research Support; Self; Dexcom, Inc., GlySens Incorporated, Medtronic, Pacific Diabetes Technologies. Jdrf australia adult hybrid closed loop trial: n/a. A. Kirby: None. S. A. Mcauley: Speaker’s Bureau; Self; Sanofi. M. H. Lee: None. B. Paldus: Speaker’s Bureau; Self; Medtronic. S. Vogrin: None. M. De bock: None. M. Burt: None.
JDRF (3-SRA-2016-351-M-B)