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

NCT01283425 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2014-09-04

No results posted yet for this 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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

InsuPatch

Heaters for single use and a permanent control unit.

Sponsors & Collaborators

  • Insuline Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Wainstein Julio, MD · Wolfsom Medical Center, Holon, Israel

  • Itamar Raz, MD · Hadassah Medical Organization

  • Klonoff David, MD · Mills Peninsula Health Services

  • Naim Shhada, MD · Rambam Health Care Campus

  • Orit Hamiel, MD · Sheba Medical Center

  • Moshe Philips, MD · Schnieder Children's Medical Center

  • Anat Yaffe, Md · Hiullel Yaffe Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01283425 on ClinicalTrials.gov