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
  Purpose

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 Intervention
Diabetics Mellitus Type 1
Diabetes Mellitus Type 2
Device: InsuPad

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Testing the Effect of the InsuPad Device in Daily Life Conditions - The InsuPad in Daily Life Study

Resource links provided by NLM:


Further study details as provided by Insuline Medical Ltd.:

Primary Outcome Measures:
  • 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.


Enrollment: 145
Study Start Date: May 2012
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594801

Locations
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
Dr. Notghi Clinical Trials
Potsdam, Germany, 14471
ikfe GmbH, Potsdam
Potsdam, Germany, 14469
Allgemeinärztliche Berufsausübungs-gemeinschaft Waldfischbach-Burgalben
Waldfischbach-Burgalben, Germany, 67714
Sponsors and Collaborators
Insuline Medical Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Insuline Medical Ltd.
ClinicalTrials.gov Identifier: NCT01594801     History of Changes
Other Study ID Numbers: CP-PP-003
Study First Received: May 6, 2012
Last Updated: March 12, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Insuline Medical Ltd.:
DM
insulin
injections

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014