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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2; Diabetics Mellitus Type 1
• Intervention / Treatment: Device: InsuPad

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aschaffenburg, Germany, 63739
    • Gemeinschaftspraxis Dr. Klausmann/ Dr. Welslau
  • Bad Mergentheim, Germany
    • Diabeteszentrum Bad Mergentheim
  • Berlin, Germany, 10115
    • ikfe GmbH, Berlin
  • Dresden, Germany, 01307
    • GWT-TUD GmbH, Zentrum für Klinische Studien
  • Mainz, Germany, 55116
    • ikfe GmbH Mainz
  • Neuwied, Germany, 56564
    • Zentrum Für Klinische Studien Neuwied
  • Potsdam, Germany, 14469
    • ikfe GmbH, Potsdam
  • Potsdam, Germany, 14471
    • Dr. Notghi Clinical Trials
  • Waldfischbach-Burgalben, Germany, 67714
    • Allgemeinärztliche Berufsausübungs-gemeinschaft Waldfischbach-Burgalben

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	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.	3 months
Safety	compare the Frequency of mild hypoglycaemia events (Blood Glucose < 63 mg/dl or 3. 5 mmol/l) with InsuPad and without InsuPad.	3 months

Collaborators and Investigators

• Sponsor: Insuline Medical Ltd.

Publications and helpful links

General Publications

• Pfutzner 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: May 6, 2012
• First Submitted That Met QC Criteria: May 8, 2012
• First Posted (Estimate): May 9, 2012

Study Record Updates

• Last Update Posted (Estimate): March 13, 2013
• Last Update Submitted That Met QC Criteria: March 12, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: insulin; DM; injections
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CP-PP-003