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

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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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical center

Jerusalem, Other, 97279, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participant age between 18- 65 years old
Type I or Type II diabetes
HbA1c 6-12%
Does not suffer from sever hypertension, kidney, liver or heart disease
Does not suffer from active Ischemic heart disease
Is willing to sign the consent form

Exclusion criteria

Participants age < 18 or > 65
Pregnancy
Breast feeding women
Un-controlled diabetes, HbA1c values > 12% range
Suffers from active Ischemic heart disease
Alcohol addiction
Is not prepared to signed the informed consent

Treatment and study plan

with heat and massage

Device

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

Primary outcomes

Insulin blood level with and with out the intervention

Time frame: at the end of every daily study

Sponsors and collaborators

Lead sponsor

Insuline Medical Ltd.

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Oct 7, 2008
Registry last updated: Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed