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Completed Phase 4 Interventional

Evaluation of the Safety Use of the InsuPatch Device in Daily Life Conditions

ClinicalTrials.gov ID: NCT01283425

Public ClinicalTrials.gov record NCT01283425. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 13, 2026, 3:01 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-label, Randomized, Two-period Crossover Study to Evaluate the Safety Use of the InsuPatch Device in Daily Life Conditions.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01283425
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Insuline Medical Ltd.
Industry
Enrollment
147 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2011
Primary completion
Mar 31, 2012
Completion
Mar 31, 2012
Last update posted
Sep 3, 2014

2011 – 2012

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Mills-Peninsula Health Services San Mateo California 94401

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01283425, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 3, 2014 · Synced Sep 13, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01283425 live on ClinicalTrials.gov.

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