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NCT01283425 · ClinicalTrials.gov registry record · Phase 4
Evaluation of the Safety Use of the InsuPatch Device in Daily Life Conditions
A Phase 4 study, sponsored by Insuline Medical.
- Completed
- Registry status
- Phase 4
- Development phase
- 147
- Enrollment target
NCT01283425: Completed Phase 4 study, sponsored by Insuline Medical.
NCT01283425 is a Phase 4 study that has completed, run by Insuline Medical. The registered enrollment target is 147 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01283425, a Phase 4 study, has completed, sponsored by Insuline Medical.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 147 participants
- Enrollment target
Study Summary
The study is an open-label, randomized, two-period crossover study. Up to one hundred and twenty (120) subjects with type 1 diabetes mellitus (T1DM) who use the MiniMed paradigm insulin pump, who meet the inclusion/exclusion criteria and who provide written Informed Consent will be enrolled in the study. The aim of the study is to examine the safety of the InsuPatch device in a home use setting. Mild Hypoglycemia,hyperglycemia and Adverse events will be compared between two phases of the study : 3 months with the use of the device and 3 months without the use of the device.
Primary Outcome
The confirmatory safety endpoint is, for each subject, frequency of mild hypoglycemia events (Blood Glucose\<60mg/dl) with InsuPatch and without. The number of events will be assessed from subject logbook and will be compared between two arms.
Interventions
- DEVICE InsuPatch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2011-02 |
| Est. Completion | 2012-04 |
| Phase | Phase 4 |
What the finished NCT01283425 record still lists
NCT01283425 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which InsuPatch is the first listed.
NCT01283425 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01283425 about?
NCT01283425 is a clinical study titled "Evaluation of the Safety Use of the InsuPatch Device in Daily Life Conditions". The study is an open-label, randomized, two-period crossover study. Up to one hundred and twenty (120) subjects with type 1 diabetes mellitus (T1DM) who use the MiniMed paradigm insulin pump, who meet the inclusion/exclusion criteria and who provide written Informed Consent will be enrolled in the s...
What is the current status of trial NCT01283425?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 147 participants. The study started on 2011-02. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01283425?
The interventions under investigation include: InsuPatch (DEVICE).
Who is sponsoring clinical trial NCT01283425?
This trial is sponsored by Insuline Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01283425's enrollment target sits among peer trials
147 570th of 2000 higher than 1,430 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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