Testing the Effect of the InsuPad Device in Daily Life Conditions

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetics Mellitus Type 1, Diabetes Mellitus Type 2

Intervention / Treatment
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* Device: InsuPad


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Subject continue their routine therapy | |
| Experimental: Test<br>Subjects using the InsuPad device | Device: InsuPad<br>* Use of the InsuPad for at least 3 times a day.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DM, insulin, injections