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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00767741
• Other study ID #: INS-0417-08-HMO
• Status: Completed
• Phase: N/A
• First received: October 4, 2008
• Last updated: April 3, 2013
• Start date: November 2010
• Est. completion date: April 2011

Study information

• Verified date: June 2011
• Source: Insuline Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah Medical center	Jerusalem	Other

Sponsors (1)

Lead Sponsor	Collaborator
Insuline Medical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin blood level with and with out the intervention		at the end of every daily study	No