Mixed Methods RCT comparing quality of life for pregnant women with type 1 diabetes using Hybrid Closed-Loop (HCL) to Sensor-Augmented Pump Therapy (SAPT).

Abstract

Objectives: Type 1 diabetes (T1D) in pregnancy is challenging. This study explores how assisted hybrid closed-loop (HCL) therapy versus sensor-augmented pump therapy (SAPT) impacts quality of life (QoL) in pregnancy.

Methods: We interviewed 22 of 24 participants randomized to HCL therapy or SAPT in the Pregnancy Intervention with a Closed-Loop System study. Participants completed questionnaires about hypoglycemia fear and device satisfaction and trust.

Results: QoL was similar among women with T1D using HCL (n=12) and SAPT (n=12) throughout pregnancy and early postpartum. Hypoglycemia fear was not statistically different between groups but improved in the HCL group in the 2^nd trimester vs baseline. Glucose monitoring satisfaction and trust increased during pregnancy in the HCL group but decreased in the SAPT group. Women trusted their mode of insulin delivery despite stress and frustration with fluctuating glucose and risks of hyperglycemia to their fetuses. Women who preferred less involvement with their management preferred HCL, while those desiring more involvement preferred SAPT.

Conclusions: These similarities demonstrate that open communication is needed between provider and patient to determine perceived benefits versus burdens of HCL use in pregnancy, especially in the United States where available HCL systems lack pregnancy-specific algorithms and FDA approval for pregnancy use.