Testing the Effect of the InsuPad Device in Daily Life Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01594801
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : March 13, 2013
Information provided by (Responsible Party):
Insuline Medical Ltd.

May 6, 2012
May 9, 2012
March 13, 2013
May 2012
February 2013   (Final data collection date for primary outcome measure)
  • Efficacy [ Time Frame: 3 months ]
    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 ]
    compare the Frequency of mild hypoglycaemia events (Blood Glucose < 63 mg/dl or 3. 5 mmol/l) with InsuPad and without InsuPad.
Same as current
Complete list of historical versions of study NCT01594801 on Archive Site
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Testing the Effect of the InsuPad Device in Daily Life Conditions
Testing the Effect of the InsuPad Device in Daily Life Conditions - The InsuPad in Daily Life Study
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.
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Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetics Mellitus Type 1
  • Diabetes Mellitus Type 2
Device: InsuPad
Use of the InsuPad for at least 3 times a day.
  • No Intervention: Control
    Subject continue their routine therapy
  • Experimental: Test
    Subjects using the InsuPad device
    Intervention: Device: InsuPad
Pfützner A, Hermanns N, Funke K, Forst T, Behnke T, Bitton G, Nagar R, Raz I, Haak T. The Barmer study: impact of standardized warming of the injection site to enhance insulin absorption and reduce prandial insulin requirements and hypoglycemia in obese patients with diabetes mellitus. Curr Med Res Opin. 2014 May;30(5):753-60. doi: 10.1185/03007995.2014.880049. Epub 2014 Jan 17.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Insuline Medical Ltd.
Insuline Medical Ltd.
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Not Provided
Insuline Medical Ltd.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP