Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies
Completed · Phase 3
Conditions studied: Diabetes Mellitus, Insulin-Dependent
In brief
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 blood when the insulin is infused using an insulin-infusion pump by controlled heating of the area surrounding the point of infusion.
Key facts
- Study ID
- NCT01216618
- Run by
- Insuline Medical Ltd.
- People needed
- 55
- Starts
- 2010-10-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2014-09-04
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 -
You may not qualify if…
- 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.
Where it is running
- Mills-Peninsula Health Services — San Mateo, California, United States
- Wolfson Medical Center — Holon, Israel
- Haddasah Medical Organization — Jerusalem, Israel
Full record on ClinicalTrials.gov
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