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NCT03774186 · ClinicalTrials.gov registry record · NA
Pregnancy Intervention With a Closed-Loop System (PICLS) Study
A NA study of Type 1 Diabetes Mellitus and Pregnancy in Diabetes, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT03774186 is a NA study of Type 1 Diabetes Mellitus and Pregnancy in Diabetes that has completed, run by University of Colorado, Denver. The registered enrollment target is 24 participants, below the 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (83% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT03774186, a NA study of Type 1 Diabetes Mellitus and Pregnancy in Diabetes, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
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 Studied
Interventions
- DEVICE Hybrid closed-loop therapy
- DEVICE Sensor-augmented pump therapy
Study Locations (2)
Colorado
- University of Colorado - Aurora
Ohio
- Ohio State University Wexner Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-03-21 |
| Est. Completion | 2022-03-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03774186
The ClinicalTrials.gov registry entry for NCT03774186 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (83% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Hybrid closed-loop therapy is the first listed.
NCT03774186 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Colorado, Ohio.
Frequently Asked Questions
What is clinical trial NCT03774186 about?
NCT03774186 is a clinical study titled "Pregnancy Intervention With a Closed-Loop System (PICLS) Study". 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)...
What is the current status of trial NCT03774186?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2019-03-21. Estimated completion is 2022-03-08.
What conditions does trial NCT03774186 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus, Pregnancy in Diabetes.
What interventions are being tested in trial NCT03774186?
The interventions under investigation include: Hybrid closed-loop therapy (DEVICE), Sensor-augmented pump therapy (DEVICE).
Who is sponsoring clinical trial NCT03774186?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03774186 being conducted?
This trial has 2 study locations across Colorado, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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