Status:
COMPLETED
Pregnancy Intervention With a Closed-Loop System (PICLS) Study
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Ohio State University
Conditions:
Type 1 Diabetes Mellitus
Pregnancy in Diabetes
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief 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, autom...
Detailed Description
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 T...
Eligibility Criteria
Inclusion
- women with T1D,
- pregnant within the first 11 weeks of gestation,
- 18 years of age or older,
- diabetes duration \>1 year,
- using MDI (multiple daily injections) or CSII (continuous subcutaneous insulin infusion) therapy,
- willingness to routinely check at least 3-7 blood glucose measurements per day,
- ability and willingness to receive routine and specialty obstetric care throughout the course of the study,
- ability and willingness to adhere to the protocol including scheduled study visits for the duration of the pregnancy and early post-partum period,
- A1C 5.5 - 9%,
- willing to participate in the run-in phase and full study (if eligible), and
- able to speak, read, and write English
Exclusion
- women with T2D, gestational diabetes, or other type of diabetes (e.g., MODY), - -
- pregnancy beyond gestational week 11 or higher,
- age \<18 years,
- T1D duration \<1 year,
- screening A1C \<5.5% or \>9%,
- use of basal insulin alone,
- use of bolus insulin alone,
- extensive skin changes/diseases that inhibit wearing an infusion set, insulin pod, or sensor on normal skin,
- known severe allergic reaction to device adhesives within the last 3 months,
- unwillingness to use an insulin pump with tubing,
- unwillingness to be randomized to study group,
- unwillingness to switch from MDI to CSII and CGM (continuous glucose monitor) use (if applicable),
- unwillingness to switch from MDI or to change from current insulin pump to HCL system (if applicable),
- severe hypoglycemic episode requiring the assistance of a 3rd party within the last 6 months,
- non-compliance with run-in phase,
- inadequate access to a phone and computer (for downloading devices and web-based communications),
- intention to move out of state within the next year, and
- any other condition determined by the PI which could make the subject unsuitable for the trial or impairs the validity of the informed consent
Key Trial Info
Start Date :
March 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03774186
Start Date
March 21 2019
End Date
March 8 2022
Last Update
November 28 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado
Aurora, Colorado, United States, 80045
2
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210