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NCT04416737 · ClinicalTrials.gov registry record · Phase 1
Evaluating the Benefits of Physiologic Insulin Delivery
A Phase 1 study of Type 1 Diabetes, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT04416737: Completed Phase 1 study of Type 1 Diabetes, sponsored by Stanford University.
NCT04416737 is a Phase 1 study of Type 1 Diabetes that has completed, run by Stanford University. The registered enrollment target is 16 participants, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04416737, a Phase 1 study of Type 1 Diabetes, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
In normal physiology insulin is secreted by beta cells into the portal vein. There have been a number of purported benefits among long-term intraperitoneal insulin users. In the present study we will inject ultra-rapid acting insulin into the upper and lower peritoneum under ultrasound guidance and compare it to subcutaneous injection. We will measure glucose, insulin and glucagon following these injections, to assess for benefits in counter-regulatory hormone production and insulin pharmacokinetics.
Primary Outcome
For each injection site we will assess the peak concentration of glucagon at time of the first induced hypoglycemic nadir. Analysis includes reporting groups for each type of injection, and upper and lower peritoneal injections combined (Injection- All Peritoneal). Participants must have achieved induced hypoglycemia to be evaluable for the primary outcome.
Conditions Studied
Interventions
- DRUG Ultra-rapid insulin
Study Locations (1)
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2023-06-02 |
| Phase | Phase 1 |
What the finished NCT04416737 record still lists
NCT04416737 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Ultra-rapid insulin is the first listed.
NCT04416737 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04416737 about?
NCT04416737 is a clinical study titled "Evaluating the Benefits of Physiologic Insulin Delivery". In normal physiology insulin is secreted by beta cells into the portal vein. There have been a number of purported benefits among long-term intraperitoneal insulin users. In the present study we will inject ultra-rapid acting insulin into the upper and lower peritoneum under ultrasound guidance and ...
What is the current status of trial NCT04416737?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2021-11-01. Estimated completion is 2023-06-02.
What conditions does trial NCT04416737 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT04416737?
The interventions under investigation include: Ultra-rapid insulin (DRUG).
Who is sponsoring clinical trial NCT04416737?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04416737 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04416737's enrollment target sits among peer trials
16 162nd of 198 higher than 34 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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