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 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 Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Randomized, Two-period Crossover Study to Evaluate the Safety Use of the InsuPatch Device in Daily Life Conditions.|
- frequency of mild hypoglycemia events (Blood Glucose<60mg/dl) with InsuPatch and without. [ Time Frame: safety will be assesed after 6 months at the study completion ] [ Designated as safety issue: Yes ]
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.
- Frequency of hyperglycemic events (BG>300 mg/dl, Fasting BG>250 mg/dl) with InsuPatch and without. [ Time Frame: safety will be assesed after 6 months at the study completion ] [ Designated as safety issue: Yes ]Frequency of hyperglycemic events (BG>300 mg/dl, Fasting BG>250 mg/dl) with InsuPatch and without.The number of events will be assesed from subject logbook and will be compared between two arms.
- Adverse events (AE's) count with InsuPatch and without. [ Time Frame: safety will be assesed after 6 months at the study completion ] [ Designated as safety issue: Yes ]Adverse events (AE's) whether or not deemed related to study device with InsuPatch and without.The number of events will be assesed dering the subject visits and bi-weekly calls and will be compared between two arms.
|Study Start Date:||February 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
InsuPatch use for 3 months.
Heaters for single use and a permanent control unit.
|No Intervention: Control|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283425
|United States, California|
|Mills-Peninsula Health Services|
|San Mateo, California, United States, 94401|
|Soroka Medical Center|
|Beer Sheva, Israel|
|Rambam Medical Center|
|Wolfson Medical Center|
|Haddasah Medical Organization|
|Schneider Children's hospital|
|Petah Tikva, Israel|
|Sheba Medical Center|
|Ramat Gan, Israel|
|Principal Investigator:||Wainstein Julio, MD||Wolfsom Medical Center, Holon, Israel|
|Principal Investigator:||Itamar Raz, MD||Hadassah Medical Organization|
|Principal Investigator:||Klonoff David, MD||Mills Peninsula Health Services|
|Principal Investigator:||Naim Shhada, MD||Rambam Health Care Campus|
|Principal Investigator:||Orit Hamiel, MD||Sheba Medical Center|
|Principal Investigator:||Moshe Philips, MD||Schnieder Children's Medical Center|
|Principal Investigator:||Anat Yaffe, Md||Hiullel Yaffe Medical Center|