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A Randomised, Controlled, Cross-over Study With Inpatient and Outpatient Phases

This study is currently Recruiting

September 2011 By Insuline Medical Ltd.

First Recieved on May 11, 2011

Last Updated on September 6, 2011

Sponsor: Insuline Medical Ltd.
Collaborators: FIDAM GmbH
Information provided by: Insuline Medical Ltd.
Identifier: NCT01352767

Purpose

A randomised, controlled, cross-over study with inpatient and outpatient phases. The inpatient phase length will be two days, which include a "Control" day without activating the InSuPad and a "Test" day where the InsuPad is activated. The outpatient phase length is 8 weeks: 4 weeks without the device-"Control", and 4 weeks with the device-"Test".

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Male or female patients aged 18 to 70 years (values included) - Type 1 diabetes mellitus or insulin treated type 2 diabetes with daily insulin demand ? 0.7 units per kg bodyweight. - 6% ? HbA1c ? 9.5% - Use of short-acting prandial insulin analogues with injections - Study subject is willing to perform at least 5 blood glucose measurements per day for at least 56 days, willing to comply with study procedures and to keep a detailed patient log book. - Willing to sign informed consent Exclusion Criteria: - Excessive fibrosis, lipo-hypertrophy or eczema at injection sites. - Known gastro- or enteroparesis. - Unstable chronic disease other than type 1 diabetes (e.g. Unstable angina factoris, , renal disease) for the last six months before study start. - Severe hypoglycemic events requiring glucagon injection or glucose infusion within the last four weeks prior to study start. - Hypoglycaemia unawareness (Score > 4 in the Hypoglycaemia Awareness Questionnaire, see appendix) - Diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study start - Any known life-threatening disease - Pregnant women, lactating women or women who intend to become pregnant during the observation period - Any other condition or compliance issues that might interfere with study participation or results - Subjects with heat sensitivity - Subjects involved in or planed to participate in other studies - Subjects who are incapable of contracting or under guardianship

Investigators

Locations

  • Bad Mergentheim

    Bad Mergentheim, Germany

Conditions related to this trial:

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