Diabetes Mellitus Type 2, Diabetics Mellitus Type 1
Conditions
Keywords
DM, insulin, injections
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.
Interventions
DEVICEInsuPad
Use of the InsuPad for at least 3 times a day.
Sponsors
Insuline Medical Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 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. |
| Safety | 3 months | compare the Frequency of mild hypoglycaemia events (Blood Glucose \< 63 mg/dl or 3. 5 mmol/l) with InsuPad and without InsuPad. |
Countries
Germany
Outcome results
None listed