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

Summary

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 (T1D) on HCL therapy or Sensor-Augmented Pump Therapy (SAPT, non-communicating pump and CGM) from the 2nd 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. 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 (\<63, 63-140, \>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.

Conditions

• Type 1 Diabetes Mellitus
• Pregnancy in Diabetes

Interventions

DEVICE

Hybrid closed-loop therapy

Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm

DEVICE

Sensor-augmented pump therapy

Insulin pump + non-communicating CGM

Sponsors & Collaborators

• Juvenile Diabetes Research Foundation

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Sarit Polsky, MD, MPH · Regents of the University of Colorado

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-21

Primary Completion

2022-03-08

Completion

2022-03-08

FDA Device

Yes

Countries

• United States

Study Locations