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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
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".
||Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
Use of the InsuPad which heats the injection site.
Routine injections no use of device
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- 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
- 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,
- 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
- 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
- Bad Mergentheim
Bad Mergentheim, Germany