Evaluation of the Effects of Heating or Massaging or Vibrating at the Vicinity of the Insulin Delivery Site
Not Applicable
Completed
- Conditions
- Diabetes
- Registration Number
- NCT00767741
- Lead Sponsor
- Insuline Medical Ltd.
- Brief Summary
The aim of this study is to test the pharmacodynamics of insulin analogs and their dependence on external and physiological alterations. We plan to compare the pharmacodynamics of insulin analog delivery in regular conditions and in the presence of increased perfusion of the delivery site, achieved by way of local warming and movement
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Participant age between 18- 65 years old
- Type I or Type II diabetes
- HbA1c 6-12%
- Does not suffer from sever hypertension, kidney, liver or heart disease
- Does not suffer from active Ischemic heart disease
- Is willing to sign the consent form
Exclusion Criteria
- Participants age < 18 or > 65
- Pregnancy
- Breast feeding women
- Un-controlled diabetes, HbA1c values > 12% range
- Suffers from active Ischemic heart disease
- Alcohol addiction
- Is not prepared to signed the informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Insulin blood level with and with out the intervention at the end of every daily study
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie insulin analog absorption enhancement via subcutaneous heating and movement in diabetes management?
How does increased subcutaneous perfusion from local warming affect insulin analog pharmacodynamics compared to standard subcutaneous injection protocols?
What biomarkers correlate with improved insulin delivery efficiency following mechanical stimulation and thermal intervention in diabetic patients?
What are the comparative adverse event profiles of heated, massaged, and vibrated insulin delivery sites versus conventional administration methods in clinical trials?
How do alternative insulin delivery methods like those tested in NCT00767741 influence glucose control metrics compared to basal-bolus insulin regimens in type 1 and type 2 diabetes?
Trial Locations
- Locations (1)
Hadassah Medical center
🇮🇱Jerusalem, Other, Israel
Hadassah Medical center🇮🇱Jerusalem, Other, Israel