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

Insuline Medical

Status: Completed

Conditions: Diabetes

Treatments: Device: with heat and massage

Study type: Interventional

Funder types: Industry

Identifiers

NCT00767741

INS-0417-08-HMO

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 1 patient group

with treatment

Experimental group

Treatment:

Device: with heat and massage