- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00767741
Evaluation of the Effects of Heating or Massaging or Vibrating at the Vicinity of the Insulin Delivery Site
April 3, 2013 updated by: Insuline Medical Ltd.
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Other
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Jerusalem, Other, Israel, 97279
- Hadassah Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: with treatment
|
For the with intervention group a treatment to the injection site is applied after each insulin bolus injection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Insulin blood level with and with out the intervention
Time Frame: at the end of every daily study
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at the end of every daily study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
October 4, 2008
First Submitted That Met QC Criteria
October 6, 2008
First Posted (Estimate)
October 7, 2008
Study Record Updates
Last Update Posted (Estimate)
April 4, 2013
Last Update Submitted That Met QC Criteria
April 3, 2013
Last Verified
June 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- INS-0417-08-HMO
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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