Testing the Effect of the InsuPad Device in Daily Life Conditions

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Insuline Medical Ltd.

ClinicalTrials.gov Identifier:

NCT01594801

First received: May 6, 2012

Last updated: March 12, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	May 6, 2012
Last Updated Date	March 12, 2013
Start Date ^ICMJE	May 2012
Primary Completion Date	February 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 8, 2012)	Efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ] The primary endpoint of the study is to demonstrate the non-inferiority (margin of 0.4%) for overall glycaemic control defined as HbA1c of a treatment regimen applying InsuPad combined with an insulin dose reduction of >10% in the test group compared to the control group not using InsuPad. Safety [ Time Frame: 3 months ] [ Designated as safety issue: Yes ] compare the Frequency of mild hypoglycaemia events (Blood Glucose < 63 mg/dl or 3. 5 mmol/l) with InsuPad and without InsuPad.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01594801 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Testing the Effect of the InsuPad Device in Daily Life Conditions
Official Title ^ICMJE	Testing the Effect of the InsuPad Device in Daily Life Conditions - The InsuPad in Daily Life Study
Brief Summary	This is the test protocol for the InsuPad device. The aim of the study is to show economical benefit when using the InsuPad device, by testing the effect of the InsuPad device on reducing injected insulin dose while keeping the same overall glycaemic control.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Diabetics Mellitus Type 1 Diabetes Mellitus Type 2
Intervention ^ICMJE	Device: InsuPad Use of the InsuPad for at least 3 times a day.
Study Arm (s)	No Intervention: Control Subject continue their routine therapy Experimental: Test Subjects using the InsuPad device Intervention: Device: InsuPad
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	145
Completion Date	March 2013
Primary Completion Date	February 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male or female subjects aged 18 to 75 years (including 18 and 75 years old). Type 1 or type 2 diabetes mellitus subjects with daily short-acting prandial insulin intake of > 60 IU/day. HbA1c >=6.0% and =< 8% Use of short-acting prandial insulin analogues with multiple daily injections. The analog insulin brands to be used will be either insulin Lispro (Humalog, Liprolog) or insulin Aspart (NovoRapid) or insulin Glulisin (Apidra). Subject agrees to sign consent form before any study-specific tests or procedures are to be performed. Study subject is willing to perform at least 5 blood glucose measurements per day for at least 3 months, willing to comply with study procedures and to keep a detailed patient log book. Exclusion Criteria: Excessive fibrosis, lipo-hypertrophy or eczema at injection sites. Known gastro- or enteroparesis. Unstable chronic disease other than diabetes mellitus (e. g. unstable angina pectoris, renal disease) for the last six months before study start. Severe hypoglycaemic 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 observation period Any other condition or compliance issues that might interfere with study participation or results Subjects with heat sensitivity Subjects involved in or planned to participate in other studies Subjects who are incapable of contracting or under guardianship
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01594801
Other Study ID Numbers ^ICMJE	CP-PP-003
Has Data Monitoring Committee	No
Responsible Party	Insuline Medical Ltd.
Study Sponsor ^ICMJE	Insuline Medical Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Insuline Medical Ltd.
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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