Evaluation of the Safety Use of the InsuPatch Device in Daily Life Conditions (Daily Life)
|ClinicalTrials.gov Identifier: NCT01283425|
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : September 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Device: InsuPatch||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||147 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Randomized, Two-period Crossover Study to Evaluate the Safety Use of the InsuPatch Device in Daily Life Conditions.|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
InsuPatch use for 3 months.
Heaters for single use and a permanent control unit.
|No Intervention: Control|
- 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 ]
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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|