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Title

Hybrid closed-loop therapy in pregnancies complicated by T1D

Project Description

In pregnancies associated with diabetes, lowering glucose to the recommended targets to prevent adverse health outcomes often leads to significant hypoglycemia. Hybrid closed-loop (HCL) therapy, automated insulin delivery using an insulin pump getting feedback from a continuous glucose monitor (CGM), may improve outcomes. This exploratory, novel pilot feasibility randomized clinical trial will evaluate pregnant women with type 1 diabetes on HCL therapy or Sensor-Augmented Pump Therapy (SAPT, non-communicating pump and CGM) from the 1st trimester, throughout pregnancy, and 4-6 weeks post-partum. Comparisons will be made on safety (Specific Aim [SA] 1), indices of glycemic variability and fear of hypoglycemia (SA 2), and quality of life and device satisfaction (SA 3) between groups. Exploratory SA 4 will compare maternal and fetal outcomes between groups. The study will screen women with an aim to have 36 completers by study end (18 HCT and 18 SAPT groups, respectively). After a 1-week run-in phase wherein women wear a CGM while logging self-monitored glucose values with fingersticks, insulin doses, carbohydrate intake, and exercise, those meeting inclusion/exclusion criteria will be randomly assigned to HCL or SAPT and trained on the devices. Baseline demographic information will be obtained. Safety data will include episodes of severe hypoglycemia requiring 3rd party assistance, diabetic ketoacidosis, and skin reactions. Glycemic control will be measured by CGM time spent in glucose ranges (140 mg/dL) and other measures of glycemic variability. Subjects will fill out surveys (Fear of Hypoglycemia, a quality of life survey, and 2 questionnaires about device satisfaction) at baseline, throughout gestation, and early post-partum. Data on maternal and fetal outcomes will be collected. Findings will reveal the safety profile and glucose control with a novel therapy for pregnant women with type 1 diabetes.

Area of Study

Child-Maternal Health and Reproductive Sciences; Pharmacology and Physiology

Populations

Pregnant Women

Method

Clinical Trials

Disease or Symptom

Diabetes; Pregnancy

Department

Physiology and Biophysics

Mentor Location

Barbara Davis Center/AMC

Mentor Contact Number

303-724-8575

Mentor Email

sarit.polsky@ucdenver.edu

Website

 

Mentor Name

Polsky, Sarit

Funding Department/Program

Barbara Davis Center

Status

Current

Display on public listing?

Yes

Upload Date

 

Attachments

Created at 8/5/2018 2:53 PM by Hom, Patrick H
Last modified at 8/5/2018 2:53 PM by Hom, Patrick H