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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 is a Phase 4 study that has completed, run by Insuline Medical. The registered enrollment target is 147 participants.
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.
Interventions
- DEVICE InsuPatch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2011-02 |
| Est. Completion | 2012-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01283425
The ClinicalTrials.gov registry entry for NCT01283425 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 147 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Insuline Medical, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which InsuPatch is the first listed.
NCT01283425 reports 0 study locations.
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.
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