- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01283425
Evaluation of the Safety Use of the InsuPatch Device in Daily Life Conditions (Daily Life)
An Open-label, Randomized, Two-period Crossover Study to Evaluate the Safety Use of the InsuPatch Device in Daily Life Conditions.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Beer Sheva, Israel
- Soroka Medical Center
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Hadera, Israel
- Hillel Yaffe
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Haifa, Israel
- Rambam Medical Center
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Holon, Israel
- Wolfson Medical Center
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Jerusalem, Israel
- Haddasah Medical Organization
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Petah Tikva, Israel
- Schneider Children's Hospital
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Ramat Gan, Israel
- Sheba Medical Center
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California
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San Mateo, California, United States, 94401
- Mills-Peninsula Health Services
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject's age range 18- 65 years old (including 18 and 65 years old)
- BMI: 18-35 kg/m2
- Type 1 diabetes patients using a MiniMed Paradigm insulin pump for at least six months, who are administering insulin Lispro or Insulin Aspart and are using the Quick-set infusion set.
- Patients with T1DM whose HbA1c values are at or below 9.5% (including 9.5%) and at or above 6% (including 6%).
- Agree to sign consent form before any study-specific tests or procedures are to be performed.
- Subject's completed at least 14 measurements during the Run-In Phase and readiness to continue the study with at least 5 blood glucose recordings per day and keep a logbook during the study period.
- Subject readiness to use the InsuPatch, his comprehension of the study requirements and treatment procedures.
- Willingness to comply with all specified follow-up evaluations.
Exclusion Criteria:
- Pregnancy
- Breast feeding women.
- Alcohol addiction
- CABG (Coronary Artery Bypass Graft), MI (Myocardial Infarction) or active Ischemic Heart Disease prior to study date.
- CVA (cardiovascular accident) or TIA (transient ischemic accident) events prior to study date.
- Uncontrolled hypertension (blood pressure in mm HG >160 systolic or > 95 diastolic) .
- Any history of gastroparesis or enteroparesis.
- Abnormal kidney and/ or liver function tests. (Defined as Creatinine >1.5 mg/dL, liver tests> 2 times the upper limit of normal).
- A severe hypoglycemic event requiring a glucagon injection or intravenous glucose infusion within the last six months prior to study inclusion.
- Hypoglycemia unawareness.
- Diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study inclusion.
- Psychological incompetence.
- Signs of drug abuse.
- Any other clinical condition or history, which seems to be relevant for the Principle Investigator to disqualify a participant.
- Subjects with diminished skin integrity, Excessive fibrosis, lipo-hypertrophy or eczema at infusion sites.
- Heat sensitive subjects.
- Subjects involved in or planning to participate in other studies.
- Subjects using any drug therapy, other than insulin, to control their blood glucose levels.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control
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Experimental: Test
InsuPatch use for 3 months.
|
Heaters for single use and a permanent control unit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
safety will be assesed after 6 months at the study completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
safety will be assesed after 6 months at the study completion
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Adverse events (AE's) count with InsuPatch and without.
Time Frame: safety will be assesed after 6 months at the study completion
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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.
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safety will be assesed after 6 months at the study completion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wainstein Julio, MD, Wolfsom Medical Center, Holon, Israel
- 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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- G080106/B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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