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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | InsuPatch use for 3 months. |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InsuPatch | Device | Heaters for single use and a permanent control unit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| frequency of mild hypoglycemia events (Blood Glucose<60mg/dl) with InsuPatch and without. | 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. | safety will be assesed after 6 months at the study completion |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of hyperglycemic events (BG>300 mg/dl, Fasting BG>250 mg/dl) with InsuPatch and without. | 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. | safety will be assesed after 6 months at the study completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mills-Peninsula Health Services | San Mateo | California | 94401 | United States | ||
| Soroka Medical Center |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Adverse events (AE's) count with InsuPatch and without. | 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. | safety will be assesed after 6 months at the study completion |
| Beersheba |
| Israel |
| Hillel Yaffe | Hadera | Israel |
| Rambam Medical Center | Haifa | Israel |
| Wolfson Medical Center | Holon | Israel |
| Haddasah Medical Organization | Jerusalem | Israel |
| Schneider Children's hospital | Petah Tikva | Israel |
| Sheba Medical Center | Ramat Gan | Israel |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |