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

May 6, 2012
March 12, 2013
May 2012
February 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01594801 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01594801
CP-PP-003
No
Insuline Medical Ltd.
Insuline Medical Ltd.
Not Provided
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