Testing the Effect of the InsuPad Device in Daily Life Conditions

Diabetes Mellitus Type 2 Clinical Trial

Official title:

Testing the Effect of the InsuPad Device in Daily Life Conditions - The InsuPad in Daily Life Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594801
• Other study ID #: CP-PP-003
• Status: Completed
• Phase: N/A
• First received: May 6, 2012
• Last updated: March 12, 2013
• Start date: May 2012
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: Insuline Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Diabetics Mellitus Type 1

Intervention

Device:
• InsuPad
Use of the InsuPad for at least 3 times a day.

Locations

Country	Name	City	State
Germany	Gemeinschaftspraxis Dr. Klausmann/ Dr. Welslau	Aschaffenburg
Germany	Diabeteszentrum Bad Mergentheim	Bad Mergentheim
Germany	ikfe GmbH, Berlin	Berlin
Germany	GWT-TUD GmbH, Zentrum für Klinische Studien	Dresden
Germany	ikfe GmbH Mainz	Mainz
Germany	Zentrum Für Klinische Studien Neuwied	Neuwied
Germany	Dr. Notghi Clinical Trials	Potsdam
Germany	ikfe GmbH, Potsdam	Potsdam
Germany	Allgemeinärztliche Berufsausübungs-gemeinschaft Waldfischbach-Burgalben	Waldfischbach-Burgalben

Sponsors (1)

Lead Sponsor	Collaborator
Insuline Medical Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes

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