We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00767741
First Posted: October 7, 2008
Last Update Posted: April 4, 2013
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.
Information provided by (Responsible Party):
Insuline Medical Ltd.
  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
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

Resource links provided by NLM:


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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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.
  More Information

Responsible Party: Insuline Medical Ltd.
ClinicalTrials.gov Identifier: NCT00767741     History of Changes
Other Study ID Numbers: INS-0417-08-HMO
First Submitted: October 4, 2008
First Posted: October 7, 2008
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