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NCT01216618 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies
A Phase 3 study of Diabetes Mellitus, Insulin-Dependent, sponsored by Insuline Medical.
- Completed
- Registry status
- Phase 3
- Development phase
- 55
- Enrollment target
- 3
- Study locations
NCT01216618: Completed Phase 3 study of Diabetes Mellitus, Insulin-Dependent, sponsored by Insuline Medical.
NCT01216618 is a Phase 3 study of Diabetes Mellitus, Insulin-Dependent that has completed, run by Insuline Medical. The registered enrollment target is 55 participants, below the 113-participant average among 3 other Diabetes Mellitus, Insulin-Dependent trials with a reported enrollment target (51% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01216618, a Phase 3 study of Diabetes Mellitus, Insulin-Dependent, has completed, sponsored by Insuline Medical.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 55 participants
- Enrollment target
- 3
- Study locations
Study Summary
The study is a prospective, multi-center, open label, randomized; two-arms cross over study. This is the test protocol for the InsuPatch device, whose purpose is to improve insulin delivery into the blood when the insulin is infused using an insulin-infusion pump by controlled heating of the area surrounding the point of infusion.
Primary Outcome
Determination of insulin delivery to the blood as measured by Insulin levels in the blood derived from blood samples collected at pre-specified time points during the glucose clamp test.
Conditions Studied
Interventions
- DEVICE InsuPatch
Study Locations (3)
Other
- Wolfson Medical Center - Holon
- Haddasah Medical Organization - Jerusalem
California
- Mills-Peninsula Health Services - San Mateo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-06 |
| Phase | Phase 3 |
What the finished NCT01216618 record still lists
NCT01216618 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 113-participant average among 3 other Diabetes Mellitus, Insulin-Dependent trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Diabetes Mellitus, Insulin-Dependent appearing as the primary indexed condition, and to 1 intervention - of which InsuPatch is the first listed.
NCT01216618 reports a single indexed study location in Other, California.
Frequently Asked Questions
What is clinical trial NCT01216618 about?
NCT01216618 is a clinical study titled "Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies". The study is a prospective, multi-center, open label, randomized; two-arms cross over study. This is the test protocol for the InsuPatch device, whose purpose is to improve insulin delivery into the blood when the insulin is infused using an insulin-infusion pump by controlled heating of the area s...
What is the current status of trial NCT01216618?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 55 participants. The study started on 2010-10. Estimated completion is 2011-06.
What conditions does trial NCT01216618 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Insulin-Dependent.
What interventions are being tested in trial NCT01216618?
The interventions under investigation include: InsuPatch (DEVICE).
Who is sponsoring clinical trial NCT01216618?
This trial is sponsored by Insuline Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01216618 being conducted?
This trial has 3 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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