Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control
This study has been completed.
Sponsor:
Deutsche Diabetes Gesellschaft
Collaborator:
Bayer
Information provided by:
Deutsche Diabetes Gesellschaft
ClinicalTrials.gov Identifier:
NCT00688363
First received: May 26, 2008
Last updated: July 29, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Procedure: weekly blood glucose profile Procedure: three-monthly haemoglobin A1c Procedure: no blood-glucose self-control |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | The Benefit of the Blood Glucose Self Monitoring and a Regular Three-monthly Hemoglobin A1c Profile in Patients With Type 2-diabetes and Conventional Insulin Therapy |
Resource links provided by NLM:
Further study details as provided by Deutsche Diabetes Gesellschaft:
Primary Outcome Measures:
- Haemoglobin A1c after one year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- a representative blood glucose profile (self monitoring) during the week before the end of the trial [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- body weight at the end of the trial [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- serum, triglycerides and cholesterol (total HDL as well as LDL-cholesterol) at the end of the trial [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- therapy-satisfaction (questionnaire) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- changes of the antidiabetic therapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- number of hospitalization as a result of hypoglycaemic episodes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- the number of serious hypoglycaemic episodes (hypoglycaemic episodes when the patient needs help from other people) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 300 |
| Study Start Date: | February 2003 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
No blood-glucose self-control, no HbA1c
|
Procedure: no blood-glucose self-control
once daily self-control of urinary-glucose
|
|
Experimental: 2
Blood-glucose self-control, no HbA1c
|
Procedure: weekly blood glucose profile
once daily self-control of urinary-glucose
|
|
Experimental: 3
No blood-glucose self-control, HbA1c
|
Procedure: three-monthly haemoglobin A1c
once daily self-control of urinary-glucose
Procedure: no blood-glucose self-control
once daily self-control of urinary-glucose
|
|
Experimental: 4
Blood-glucose self-control, HbA1c
|
Procedure: weekly blood glucose profile
once daily self-control of urinary-glucose
Procedure: three-monthly haemoglobin A1c
once daily self-control of urinary-glucose
|
Detailed Description:
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:
- no regular blood-glucose self-monitoring, no regular HbA1c
- regular blood glucose self monitoring, no regular HbA1c
- no regular blood glucose self monitoring, regular HbA1c
- regular blood glucose self monitoring, regular HbA1c
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.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 2-diabetes (ADA/WHO-Criteria)
- Conventional insulin therapy ( 1-3 daily injections of basal- and/or mixed insulin also in combination with oral agents.)
- Age:> 40 years
- BMI:> 20 kg/m²
Exclusion Criteria:
- Impaired liver function, defined as > 2 times upper limit of normal
- Impaired renal function defined liver enzymes as serum-creatinine > 1.3 mg/dl
- Gastro-intestinal diseases (disturbances, diagnoses)
- Inability to perform study-related activities according to the present protocol
- Pregnancy not certainly excluded
- Abuse of alcohol and/or other drugs
- Participation in other clinical trials during the past 3 month
- Threat to general state of health
- Intensified insulin therapy (at least 3 times rapid-acting insulin)
- Frequent blood glucose self monitoring during the past 3 months (more than one 4-point glucose profile per week or more than one blood glucose/ urinary glucose test per day )
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688363
Locations
| Germany | |
| Diabeteszentrum Bad Lauterberg | |
| Bad Lauterberg, Niedersachsen, Germany, D-37431 | |
| Koch, Peter | |
| Bad Harzburg, Germany, 38667 | |
| Maxeiner, Stefan | |
| Bad Kreuznach, Germany, 55545 | |
| Friedrichs, Michael | |
| Bad Lauterberg, Germany, 37431 | |
| Jödicke, Carmen | |
| Bad Lauterberg, Germany, 37431 | |
| Mulch-Wiemer, Christa | |
| Bad Nauheim, Germany, 61231 | |
| Bellmann, Renate | |
| Berlin, Germany, 10365 | |
| Schoch, Daniela | |
| Berlin, Germany, 13055 | |
| Warmers, Ulrike | |
| Bitburg, Germany, 54634 | |
| Leupold, Manfred | |
| Borna, Germany, 04552 | |
| Kamke, Wolfram | |
| Burg/Sreewald, Germany, 03096 | |
| Hildebrandt, Rüdiger | |
| Clausthal-Zellerfeld, Germany, 38678 | |
| Lemmerhirt, Jürgen | |
| Cuxhaven, Germany, 27474 | |
| Preuß, Uwe | |
| Datteln, Germany, 45711 | |
| Weller, Ulrich | |
| Dorsten, Germany, 46282 | |
| Fischer, Harald | |
| Düren, Germany, 52351 | |
| Krege, Peter | |
| Emsdetten, Germany, 48282 | |
| Gölz, Stefan | |
| Esslingen, Germany, 73728 | |
| Wollersen, Karin | |
| Freiburg, Germany, 79106 | |
| Hendel, Andreas | |
| Grassau, Germany, 83224 | |
| Pfeiffer, Martha | |
| Gronau, Germany, 48559 | |
| Jäger, Michael | |
| Höchst, Germany, 64739 | |
| Müller, Ulrich. A. | |
| Jena, Germany, 07740 | |
| Niemetz, Ingo | |
| Kassel, Germany, 34117 | |
| Schmitz, Ulrike | |
| Krefeld, Germany, 47805 | |
| Kourbanova, Zarema | |
| Langenfeld, Germany, 40764 | |
| Willms, Gerhard | |
| Leverkusen, Germany, 51373 | |
| Ley, Heinz-Georg | |
| Marl, Germany, 45770 | |
| Grossmann, J. | |
| Mönchengladbach, Germany, 41061 | |
| Füchtenbusch, Martin | |
| München, Germany, 80804 | |
| Fueting, Frank | |
| Nassau, Germany, 56377 | |
| Behnke, Thomas | |
| Neuwied, Germany, 56564 | |
| Böhme, Rainer | |
| Nordhausen, Germany, 99734 | |
| Fels, Stefan | |
| Oldenburg, Germany, 28131 | |
| Klein, Frank | |
| Schenklengsfeld, Germany, 36277 | |
| Naumann, Rainer | |
| Schöppenstedt, Germany, 38170 | |
| Rieth-Kunert, Anna | |
| Stade, Germany, 21684 | |
| Nowack, Kirsten | |
| Torgau, Germany, 04860 | |
| Schmidt-Reinwald, Astrid | |
| Waldrach, Germany, 54320 | |
| Bödecker, A.-W. | |
| Wiehl, Germany, 51674 | |
| Oerter, Erika-Maria | |
| Würzburg, Germany, 97084 | |
Sponsors and Collaborators
Deutsche Diabetes Gesellschaft
Bayer
Investigators
| Principal Investigator: | Michael A. Nauck, Prof. Dr. | Diabeteszentrum Bad Lauterberg |
More Information
No publications provided
| Responsible Party: | Prof. Dr. M. Nauck, Kommission Klinische Studien der DDG |
| ClinicalTrials.gov Identifier: | NCT00688363 History of Changes |
| Other Study ID Numbers: | KKS 2003-Nauck-01 |
| Study First Received: | May 26, 2008 |
| Last Updated: | July 29, 2011 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Deutsche Diabetes Gesellschaft:
|
Diabetes control glycated haemoglobin blood-glucose-self-monitoring type 2-diabetes conventional insulin therapy |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013