Status:
COMPLETED
Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies
Lead Sponsor:
Insuline Medical Ltd.
Conditions:
Diabetes Mellitus, Insulin-Dependent
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The study is a prospective, multi-center, open label, randomized; two-arms cross over study. This is the test protocol for the InsuPatch device, whose purpose is to improve insulin delivery into the ...
Detailed Description
Fifty five(55) type 1 IDDM subjects in three centers who use the MiniMed paradigm insulin pump, meeting the inclusion/exclusion criteria as outlined below and who provide written Informed Consent will...
Eligibility Criteria
Inclusion
- Age between 18- 65 years old (including = 18 years and =65 years)
- Gender: men and women
- BMI: 18-35 kg/m2
- Type 1 Insulin dependent diabetes using the MiniMed paradigm insulin pumps for at least six months and using insulin Lispro or Insulin Aspart.
- Diabetic subjects with HbA1c values below 9.5% (including 9.5%).
- Subject understands the study requirements and the treatment procedures and has signed an Informed Consent before any study-specific tests or procedures are performed
- Subject is willing to comply with all specified follow-up evaluations -
Exclusion
- Pregnancy
- Breast feeding women.
- Alcohol addiction
- Had CABG (Coronary Artery Bypass Graft), are Post MI (Myocardial Infarction) or had active Ischemic heart disease prior to the study date
- Had CVA (cardiovascular accident) or TIA (transient ischemic accident) prior to the study
- Suffer from uncontrolled Hypertension (blood pressure in mm HG \>160 systolic or \> 95 diastolic)
- Low blood hemoglobin concentration \<9 g/dL for female and \<11g/dL for male.
- Abnormal kidney and/ or liver function tests. (If any of the liver or kidney function test parameters are greater than 3 fold normal values.
- Subjects with Hyperthyroidism or Hypothyroidism with TSH level outside the normal range, TSH\>5.5 mIU/L or TSH\<0.4 mIU/L
- 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 planed to participate in other studies
- Subjects using other drugs therapies to control blood glucose level other than insulin.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01216618
Start Date
October 1 2010
End Date
June 1 2011
Last Update
September 4 2014
Active Locations (3)
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1
Mills-Peninsula Health Services
San Mateo, California, United States, 94401
2
Wolfson Medical Center
Holon, Israel
3
Haddasah Medical Organization
Jerusalem, Israel