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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Insuline Medical Ltd.
ClinicalTrials.gov Identifier:
NCT00767741
First received: October 4, 2008
Last updated: April 3, 2013
Last verified: June 2011
History of Changes
  Purpose

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 Intervention
Diabetes
 Device: with heat and massage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Insuline Medical Ltd.:

Primary Outcome Measures:
  • Insulin blood level with and with out the intervention [ Time Frame: at the end of every daily study ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: November 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767741

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

No publications provided

Responsible Party: Insuline Medical Ltd.
ClinicalTrials.gov Identifier: NCT00767741     History of Changes
Other Study ID Numbers: INS-0417-08-HMO
Study First Received: October 4, 2008
Last Updated: April 3, 2013
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013