Status:
UNKNOWN
Evaluation of the Effects of Heating the Vicinity of the Insulin Delivery Site by the Experimental Device
Lead Sponsor:
Insuline Medical Ltd.
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The study is an open-label, randomized, two-period, one-way crossover study using the Meal Tolerance Test (MTT) protocol or the daily life setting protocol. The study consists of two parts. Subject m...
Detailed Description
The effect of the InsuPad device was studied using the Meal Tolerance Test protocol or the daily life setting protocol. In the Meal Tolerance Test protocol subjects consumed a standardized liquid meal...
Eligibility Criteria
Inclusion
- Participant age above 18 (including = 18 years)
- BMI above 18kg/m2
- Insulin dependent diabetes using insulin injections
- Diabetic patients with HbA1c values below 12%
- Participant understands the study requirements and the treatment procedures ,willing to comply with all specified follow-up evaluations and provides written Informed Consent before any study-specific tests or procedures are performed
Exclusion
- Pregnancy
- Breast feeding women
- Alcohol addiction
- Had Coronary Artery Bypass Graft, are Post Myocardial Infarction or had active Ischemic heart failure in the last 3 months prior to the study date
- Had cardiovascular accident or transient ischemic accident in the last 12 months prior to the study
- Suffer from uncontrolled Hypertension (blood pressure \> 165/90)
- Low blood hemoglobin concentration \<9 g/dL for female and \<12g/dL for male)
- Low Hematocrit concentration \<36%; Abnormal kidney and/ or liver function tests. (Creatinine \>2 , liver test\> 3 times the upper limit of the normal range)
- Psychological incompetence; Any other clinical condition or history, that seems to be relevant to the principle investigator to disqualify the participant
- Subjects with diminished skin integrity
- Subjects with heat sensitivity
- Subjects involved in or planned to participate in other studies that may interfere in data collection.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02306343
Start Date
November 1 2011
End Date
September 1 2015
Last Update
December 3 2014
Active Locations (1)
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1
InsuLine Medical
Petah Tikva, Israel, 4900202