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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00767741
Recruitment Status : Completed
First Posted : October 7, 2008
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):

October 4, 2008
October 7, 2008
April 4, 2013
November 2010
April 2011   (Final data collection date for primary outcome measure)
Insulin blood level with and with out the intervention [ Time Frame: at the end of every daily study ]
Same as current
Complete list of historical versions of study NCT00767741 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of the Effects of Heating or Massaging or Vibrating at the Vicinity of the Insulin Delivery Site
Evaluation of the Effects of Heating or Massaging or Vibrating at the Vicinity of the Insulin Delivery Site
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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Diabetes
Device: with heat and massage
For the with intervention group a treatment to the injection site is applied after each insulin bolus injection.
Experimental: with treatment
Intervention: Device: with heat and massage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2011
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00767741
INS-0417-08-HMO
No
Not Provided
Not Provided
Insuline Medical Ltd.
Insuline Medical Ltd.
Not Provided
Not Provided
Insuline Medical Ltd.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP