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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.
 
ClinicalTrials.gov Identifier: NCT01594801
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : March 13, 2013
Sponsor:
Information provided by (Responsible Party):
Insuline Medical Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetics Mellitus Type 1 Diabetes Mellitus Type 2 Device: InsuPad Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Testing the Effect of the InsuPad Device in Daily Life Conditions - The InsuPad in Daily Life Study
Study Start Date : May 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 2013

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Subject continue their routine therapy
Experimental: Test
Subjects using the InsuPad device
 Device: InsuPad
Use of the InsuPad for at least 3 times a day.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594801


Locations
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Germany
Gemeinschaftspraxis Dr. Klausmann/ Dr. Welslau
Aschaffenburg, Germany, 63739
Diabeteszentrum Bad Mergentheim
Bad Mergentheim, Germany
ikfe GmbH, Berlin
Berlin, Germany, 10115
GWT-TUD GmbH, Zentrum für Klinische Studien
Dresden, Germany, 01307
ikfe GmbH Mainz
Mainz, Germany, 55116
Zentrum Für Klinische Studien Neuwied
Neuwied, Germany, 56564
ikfe GmbH, Potsdam
Potsdam, Germany, 14469
Dr. Notghi Clinical Trials
Potsdam, Germany, 14471
Allgemeinärztliche Berufsausübungs-gemeinschaft Waldfischbach-Burgalben
Waldfischbach-Burgalben, Germany, 67714
Sponsors and Collaborators
Insuline Medical Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Insuline Medical Ltd.
ClinicalTrials.gov Identifier: NCT01594801    
Other Study ID Numbers: CP-PP-003
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: March 13, 2013
Last Verified: March 2013
Keywords provided by Insuline Medical Ltd.:
DM
insulin
injections
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases