Hybrid closed loop insulin therapy versus standard therapy in pregnant women with type 1 diabetes: A systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE

We aimed to explore the efficacy and safety of hybrid closed loop (HCL) systems compared to standard care (SC) in pregnant women with Type 1 Diabetes Mellitus (T1DM), pooling results from randomized controlled trials (RCTs).

DATA SOURCES

We searched through multiple databases like PubMed, Cochrane, Embase, Web of Science, and Clinicaltrials.gov etc. from inception to September 2024 and found six relevant studies after screening.

STUDY ELIGIBILITY CRITERIA

We included studies that were (1) RCTs; with patient population (2) pregnant patients with type 1 diabetes; intervention group receiving (3) HCL and control group receiving (4) SC; while reporting (5) outcomes of interest (endpoints). We pooled results pertaining to primary outcomes; time in range (TIR), nocturnal time in range (nTIR), and HbA1c; and relevant secondary outcomes.

STUDY APPRAISAL AND SYNTHESIS METHODS

We used Rob 2: A revised Cochrane risk-of-bias tool for randomized trials for quality assessment of the included RCTs. We employed the DerSimonian-Laird random effects model using review manager 5.4 to analyze the pooled estimates and reported results as risk ratio; for dichotomous outcomes; or mean difference; for continuous outcomes.

RESULTS

Five RCTs (n = 274) with disparate populations were narrowed down for analysis. Pooled estimates for TIR (MD 4.95 %;-0.56 to 10.49)and HbA1c% (MD 0.09; -0.44 to 0.63) were statistically non-significant, while estimates for nTIR (MD 11.16 %; 7.15 to 15.15), % time < 63 mg/dL (MD -0.78; -1.36 to -0.20), % of time < 54 mg/dL (MD -0.22; -0.40 to -0.03), low blood glucose index (LBGI) (MD -0.30; -0.54 to -0.06), and glucose standard deviation (MD -3.05; -6.06 to -0.04) favored HCL over SC. No significant between-group differences were found in other secondary outcomes: % of time >140 mg/dL, % of time >180 mg/dL, mean glucose level, rate of serious adverse events, cesarian delivery, and severe hypoglycemia.

CONCLUSIONS

HCL systems can improve glycemic control in pregnant women with T1DM with a tolerable adverse event profile, however more research is needed to draw a definitive conclusion.