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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The purpose of this randomized, prospective trial is to determine wether (a) a once weekly glucose profile (self monitoring) or (b) a three-monthly report of the actual glycated haemoglobin are effective interventions to improve HbA1c after one year in typ 2-diabetic patients on conventional insulin treatment.
The design is an open, prospective, randomised, multicentre parallel group study. The total duration will be 5 years with patient recruitment over 4 years and an individual observation period of 1 year. 300 participants from 43 study centres, hospitals and private practices were recruited. The study will run for one year and aims to determine, whether there is an advantage with regard to HbA1c levels when (a) a regular three-monthly HbA1c or (b) a weekly 4-point glucose profile is taken and reported.
After screening, patients will be assigned at random to one of the following study arms:
The control for all participants is that urinary glucose should be monitored at least once a day, preferably in the late morning, as the highest increase in plasma glucose level occurs after breakfast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | No blood-glucose self-control, no HbA1c |
|
| 2 | Experimental | Blood-glucose self-control, no HbA1c |
|
| 3 | Experimental | No blood-glucose self-control, HbA1c |
|
| 4 | Experimental | Blood-glucose self-control, HbA1c |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| weekly blood glucose profile | Procedure | once daily self-control of urinary-glucose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Haemoglobin A1c after one year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| a representative blood glucose profile (self monitoring) during the week before the end of the trial | 1 year | |
| body weight at the end of the trial | 1 year | |
| serum, triglycerides and cholesterol (total HDL as well as LDL-cholesterol) at the end of the trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A. Nauck, Prof. Dr. | Diabeteszentrum Bad Lauterberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabeteszentrum Bad Lauterberg | Bad Lauterberg im Harz | Lower Saxony | D-37431 | Germany | ||
| Koch, Peter |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24445534 | Derived | Nauck MA, Haastert B, Trautner C, Muller UA, Nauck MA, Heinemann L; Clinical Trials Study Group of the German Association for the Study of Diabetes (Deutsche Diabetes-Gesellschaft). A randomised, controlled trial of self-monitoring of blood glucose in patients with type 2 diabetes receiving conventional insulin treatment. Diabetologia. 2014 May;57(5):868-77. doi: 10.1007/s00125-014-3168-1. Epub 2014 Jan 21. |
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| three-monthly haemoglobin A1c |
| Procedure |
once daily self-control of urinary-glucose |
|
| no blood-glucose self-control | Procedure | once daily self-control of urinary-glucose |
|
| 1 year |
| therapy-satisfaction (questionnaire) | 1 year |
| changes of the antidiabetic therapy | 1 year |
| number of hospitalization as a result of hypoglycaemic episodes | 1 year |
| the number of serious hypoglycaemic episodes (hypoglycaemic episodes when the patient needs help from other people) | 1 year |
| Bad Harzburg |
| 38667 |
| Germany |
| Maxeiner, Stefan | Bad Kreuznach | 55545 | Germany |
| Friedrichs, Michael | Bad Lauterberg im Harz | 37431 | Germany |
| Jödicke, Carmen | Bad Lauterberg im Harz | 37431 | Germany |
| Mulch-Wiemer, Christa | Bad Nauheim | 61231 | Germany |
| Bellmann, Renate | Berlin | 10365 | Germany |
| Schoch, Daniela | Berlin | 13055 | Germany |
| Warmers, Ulrike | Bitburg | 54634 | Germany |
| Leupold, Manfred | Borna | 04552 | Germany |
| Kamke, Wolfram | Burg/Sreewald | 03096 | Germany |
| Hildebrandt, Rüdiger | Clausthal-Zellerfeld | 38678 | Germany |
| Lemmerhirt, Jürgen | Cuxhaven | 27474 | Germany |
| Preuß, Uwe | Datteln | 45711 | Germany |
| Weller, Ulrich | Dorsten | 46282 | Germany |
| Fischer, Harald | Düren | 52351 | Germany |
| Krege, Peter | Emsdetten | 48282 | Germany |
| Gölz, Stefan | Esslingen am Neckar | 73728 | Germany |
| Wollersen, Karin | Freiburg im Breisgau | 79106 | Germany |
| Hendel, Andreas | Grassau | 83224 | Germany |
| Pfeiffer, Martha | Gronau | 48559 | Germany |
| Jäger, Michael | Höchst | 64739 | Germany |
| Müller, Ulrich. A. | Jena | 07740 | Germany |
| Niemetz, Ingo | Kassel | 34117 | Germany |
| Schmitz, Ulrike | Krefeld | 47805 | Germany |
| Kourbanova, Zarema | Langenfeld | 40764 | Germany |
| Willms, Gerhard | Leverkusen | 51373 | Germany |
| Ley, Heinz-Georg | Marl | 45770 | Germany |
| Grossmann, J. | Mönchengladbach | 41061 | Germany |
| Füchtenbusch, Martin | München | 80804 | Germany |
| Fueting, Frank | Nassau | 56377 | Germany |
| Behnke, Thomas | Neuwied | 56564 | Germany |
| Böhme, Rainer | Nordhausen | 99734 | Germany |
| Fels, Stefan | Oldenburg | 28131 | Germany |
| Klein, Frank | Schenklengsfeld | 36277 | Germany |
| Naumann, Rainer | Schöppenstedt | 38170 | Germany |
| Rieth-Kunert, Anna | Stade | 21684 | Germany |
| Nowack, Kirsten | Torgau | 04860 | Germany |
| Schmidt-Reinwald, Astrid | Waldrach | 54320 | Germany |
| Bödecker, A.-W. | Wiehl | 51674 | Germany |
| Oerter, Erika-Maria | Würzburg | 97084 | Germany |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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