Pregnancy Intervention With a Closed-Loop System (PICLS) Study

This is a two‐center, prospective, 'open‐label', single‐blind, investigator‐initiated randomized controlled pilot study evaluating hybrid closed‐loop (HCL) insulin delivery among pregnant women with T1D compared with sensor‐augmented pump therapy (SAPT) throughout most of gestation and the first 6 weeks of the post‐partum period at the Barbara Davis Center for Diabetes and Ohio State University. Up to 47 women will be enrolled at ≤9 weeks gestation, sign informed consent, and begin a run‐in phase. At baseline, the investigators will obtain data about demographics, health history, pregnancy history, and medication use. The investigators will conduct a physical exam, download diabetes devices already in use by subjects, obtain blood and urine tests, and administer validated questionnaires (Hypoglycemia Fear Survey, MOS Short‐Form 36 [SF‐26], INSPIRE Questionnaire, Insulin Delivery Satisfaction Survey [IDSS], and Glucose Monitoring Satisfaction Survey [GMSS]). During run‐in, women will wear a CGM, fill out log sheets (glucose levels, insulin doses, carbohydrate intake, exercise), upload the CGM, and be in contact with research staff. Eligible subjects will then be trained on study devices for SAPT therapy. At the start of the 2nd trimester, women will be randomized to SAPT or HCL therapy. During pregnancy, women will be seen at each institution monthly for vital signs, HbA1c measurements, device downloads, pump adjustments, medication use, reporting of adverse events and device‐related deficiencies, and once a trimester the investigators will additionally obtain serum and urine measurements, specimens for the repository of biological specimens, and ask subjects to fill out questionnaires (Hypoglycemia Fear Survey, SF‐35, IDSS, GMSS). Weekly remote contact will be obtained for pump adjustments and reporting of adverse events and device‐related deficiencies. Women on HCL therapy will use SAPT during labor and delivery until 3‐7 days post‐partum, when a study clinician will put them back into auto mode (HCL therapy), if it is safe to do so. The final study visit will take place 4‐6 weeks post‐partum where the physical exam will be done, HbA1c obtained, device downloads obtained, and final questionnaires submitted (as above plus a post‐partum survey). Medical records of the labor and delivery admission will be obtained.