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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: with heat and massage

• Registration Number: NCT00767741
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-04
• Study First Submitted QC: 2008-10-06
• Study First Posted: 2008-10-07
• Study Start: 2010-11
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-06
• Last Update Submitted: 2013-04-03
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
with treatment	with heat and massage	-

Primary Outcome Measures

Name	Time	Method
Insulin blood level with and with out the intervention	at the end of every daily study

Trial Locations

Locations (1)

Hadassah Medical center; 🇮🇱 Jerusalem, Other, Israel