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Evaluation of the Effects of Heating or Massaging or Vibrating at the Vicinity of the Insulin Delivery Site

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ClinicalTrials.gov Identifier: NCT00767741
Recruitment Status : Completed
First Posted : October 7, 2008
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Diabetes Device: with heat and massage Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Effects of Heating or Massaging or Vibrating at the Vicinity of the Insulin Delivery Site
Study Start Date : November 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: with treatment Device: with heat and massage
For the with intervention group a treatment to the injection site is applied after each insulin bolus injection.



Primary Outcome Measures :
  1. Insulin blood level with and with out the intervention [ Time Frame: at the end of every daily study ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant age between 18- 65 years old
  2. Type I or Type II diabetes
  3. HbA1c 6-12%
  4. Does not suffer from sever hypertension, kidney, liver or heart disease
  5. Does not suffer from active Ischemic heart disease
  6. Is willing to sign the consent form

Exclusion Criteria:

  1. Participants age < 18 or > 65
  2. Pregnancy
  3. Breast feeding women
  4. Un-controlled diabetes, HbA1c values > 12% range
  5. Suffers from active Ischemic heart disease
  6. Alcohol addiction
  7. Is not prepared to signed the informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00767741


Locations
Israel
Hadassah Medical center
Jerusalem, Other, Israel, 97279
Sponsors and Collaborators
Insuline Medical Ltd.

Responsible Party: Insuline Medical Ltd.
ClinicalTrials.gov Identifier: NCT00767741     History of Changes
Other Study ID Numbers: INS-0417-08-HMO
First Posted: October 7, 2008    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: June 2011

Keywords provided by Insuline Medical Ltd.:
diabetes
post prandial glucose level
insulin
pharmacokinetics
pharmacodynamics

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs