Testing the Effect of the InsuPad Device in Daily Life Conditions
This study has been completed.
Information provided by (Responsible Party):
Insuline Medical Ltd.
First received: May 6, 2012
Last updated: March 12, 2013
Last verified: March 2013
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.
Diabetics Mellitus Type 1
Diabetes Mellitus Type 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Testing the Effect of the InsuPad Device in Daily Life Conditions - The InsuPad in Daily Life Study
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2013 (Final data collection date for primary outcome measure)
No Intervention: Control
Subject continue their routine therapy
Subjects using the InsuPad device
Use of the InsuPad for at least 3 times a day.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594801
|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 |
|ikfe GmbH, Potsdam
|Potsdam, Germany, 14469 |
|Dr. Notghi Clinical Trials
|Potsdam, Germany, 14471 |
|Allgemeinärztliche Berufsausübungs-gemeinschaft Waldfischbach-Burgalben
|Waldfischbach-Burgalben, Germany, 67714 |
Insuline Medical Ltd.
No publications provided
||Insuline Medical Ltd.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 6, 2012
||March 12, 2013
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by Insuline Medical Ltd.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2013
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases