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NCT03215914 · ClinicalTrials.gov registry record · NA
Hybrid Closed Loop Insulin Delivery System in Hypoglycemia
A NA study of Type 1 Diabetes and Hypoglycemia, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 3
- Study locations
NCT03215914: Completed NA study of Type 1 Diabetes and Hypoglycemia, sponsored by University of Pennsylvania.
NCT03215914 is a NA study of Type 1 Diabetes and Hypoglycemia that has completed, run by University of Pennsylvania. The registered enrollment target is 10 participants, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03215914, a NA study of Type 1 Diabetes and Hypoglycemia, 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.
Primary Outcome
The primary outcome measure will be endogenous glucose production in response to insulin-induced hypoglycemia.
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 |
What the finished NCT03215914 record still lists
NCT03215914 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (99% lower).
The record links to 5 conditions, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which MiniMed 670G system is the first listed.
NCT03215914 reports a single indexed study location in 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: Type 1 Diabetes, Hypoglycemia, 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.
Learn More About Clinical Trials
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Where NCT03215914's enrollment target sits among peer trials
10 182nd of 198 higher than 9 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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