Advanced hybrid closed loop therapy compared to standard insulin therapy intrapartum and early postpartum in women with type 1 diabetes: a secondary observational analysis from the randomized controlled CRISTAL trial
Objective
To determine efficacy and safety of intrapartum and early postpartum advanced hybrid closed loop (AHCL) therapy compared to standard insulin therapy (SoC) in pregnant individuals with type 1 diabetes (T1D).
Research Design and Methods
CRISTAL was a double-arm, open-label, randomized controlled trial in Belgium and the Netherlands, in which 95 pregnant participants with T1D were randomly assigned (1:1) to MiniMed™ 780G AHCL (n=46) or SoC (n=49). This prespecified secondary observational analysis focused on differences in glycemic control and safety outcomes between participants from the original AHCL group who continued AHCL intrapartum (n=27) and/or early postpartum (n=37, until hospital discharge) and participants from the original SoC group using SoC intrapartum (n=45) and/or early postpartum (n=34).
Results
Of the 43 (AHCL) and 46 (SoC) participants completing the trial, 27 (62.8%) continued AHCL and 45 (97.8%) SoC intrapartum, respectively. Compared to SoC, intrapartum AHCL was associated with higher time in range 3.5-7.8 mmol/L (71.5±17.7% vs. 63.1±17.0%, P=0.030), numerically lower time above range >7.8 mmol/L (27.3±17.4% vs. 35.3±17.5%, P=0.054), without increased time below range <3.5 mmol/L (1.1±2.4% vs. 1.5±2.3%, P=0.146). Early postpartum, 37 (86.0%) participants randomized to AHCL used AHCL, with a median increase in insulin-to-carbohydrate ratios of 67% (IQR -14-126). Similar tight glycemic control (3.9-10.0 mmol/L: 86.8±6.7% vs. 83.8±8.1%, P=0.124) was observed with AHCL versus SoC. No severe hypoglycemia or diabetic ketoacidosis was reported in either group.
Conclusions
AHCL is effective in maintaining tight glycemic control intrapartum and early postpartum and can be safely continued during periods of rapidly changing insulin requirements.
