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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Subject continue their routine therapy | |
| Test | Experimental | Subjects using the InsuPad device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InsuPad | Device | Use of the InsuPad for at least 3 times a day. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gemeinschaftspraxis Dr. Klausmann/ Dr. Welslau | Aschaffenburg | 63739 | Germany | |||
| Diabeteszentrum Bad Mergentheim |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24392996 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Bad Mergentheim |
| Germany |
| ikfe GmbH, Berlin | Berlin | 10115 | Germany |
| GWT-TUD GmbH, Zentrum für Klinische Studien | Dresden | 01307 | Germany |
| ikfe GmbH Mainz | Mainz | 55116 | Germany |
| Zentrum Für Klinische Studien Neuwied | Neuwied | 56564 | Germany |
| ikfe GmbH, Potsdam | Potsdam | 14469 | Germany |
| Dr. Notghi Clinical Trials | Potsdam | 14471 | Germany |
| Allgemeinärztliche Berufsausübungs-gemeinschaft Waldfischbach-Burgalben | Waldfischbach-Burgalben | 67714 | Germany |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |