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NCT03215914 · ClinicalTrials.gov registry record · NA
Hybrid Closed Loop Insulin Delivery System in Hypoglycemia
A NA study of Hypoglycemia and Type1diabetes, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 3
- Study locations
NCT03215914 is a NA study of Hypoglycemia and Type1diabetes that has completed, run by University of Pennsylvania. The registered enrollment target is 10 participants, below the 506-participant average among 40 other Hypoglycemia trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT03215914, a NA study of Hypoglycemia and Type1diabetes, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 3
- Study locations
Study Summary
Can a type 1 diabetic adult avoid low glucoses and regain hypoglycemia awareness using a hybrid closed loop insulin delivery system? Involvement is 22 months (13 visits) and includes a 4-week Screening Phase and an 18-month Intervention Phase. Participants will undergo 3 Hyperinsulinemic Clamps done at: Baseline (before starting the device and after completing the screening), 6 months (after using the device 6 months), and after using the device for 18 months. This metabolic testing will allow us to measure improvement in hypoglycemia awareness.
Conditions Studied
Interventions
- DEVICE MiniMed 670G system
Study Locations (3)
Pennsylvania
- Clinical and Translational Research Center, Hospital of University of Pennsylvania - Philadelphia
- Rodebaugh Diabetes Center, University of Pennsylvania - Philadelphia
- University of Pennsylvania - Institute for Diabetes, Obesity and Metabolism - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2024-10-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03215914
The ClinicalTrials.gov registry entry for NCT03215914 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 506-participant average among 40 other Hypoglycemia trials with a reported enrollment target (98% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Hypoglycemia appearing as the primary indexed condition, and to 1 intervention - of which MiniMed 670G system is the first listed.
NCT03215914 reports 3 study locations spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03215914 about?
NCT03215914 is a clinical study titled "Hybrid Closed Loop Insulin Delivery System in Hypoglycemia". Can a type 1 diabetic adult avoid low glucoses and regain hypoglycemia awareness using a hybrid closed loop insulin delivery system? Involvement is 22 months (13 visits) and includes a 4-week Screening Phase and an 18-month Intervention Phase. Participants will undergo 3 Hyperinsulinemic Clamps done...
What is the current status of trial NCT03215914?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2017-08-01. Estimated completion is 2024-10-01.
What conditions does trial NCT03215914 study?
This clinical trial studies the following conditions: Hypoglycemia, Type1diabetes, Hypoglycemia Unawareness, Nocturnal Hypoglycemia, Hypoglycemia Night.
What interventions are being tested in trial NCT03215914?
The interventions under investigation include: MiniMed 670G system (DEVICE).
Who is sponsoring clinical trial NCT03215914?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03215914 being conducted?
This trial has 3 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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