NCT01283425

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Insuline Medical Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study is to show that safety parameters are similar, when delivering insulin subcutaneously in subjects with type I diabetes using the InsuPatch device along with the Medtronic Minimed Paradigm insulin infusion pump and the Medtronic Minimed Quick-Set® infusion set compared to subcutaneous insulin delivered with the above mentioned equipment, without the InsuPatch device. The participation of each subject in this study will be up to seven months and will include three phases: one week Run in phase , 3 months with device use and 3 months without device use. Study will include 4 clinic visits and bi weekly calls. During the entire study the subjects will be requested to preform at least 5 blood glucose self measurements and record results in a logbook.At each visit blood will be drawn for HBA1C test.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	InsuPatch	Heaters for single use and a permanent control unit.

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-01-26
• Last updated: 2014-09-04

Locations

8 sites across 2 countries: United States, Israel