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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-04-30

Brief Summary

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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

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Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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with treatment

Group Type EXPERIMENTAL

with heat and massage

Intervention Type DEVICE

For the with intervention group a treatment to the injection site is applied after each insulin bolus injection.

Interventions

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with heat and massage

For the with intervention group a treatment to the injection site is applied after each insulin bolus injection.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No