Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control
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
1 other identifier
interventional
300
1 country
41
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes
Started Feb 2003
Longer than P75 for phase_4 type-2-diabetes
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 26, 2008
CompletedFirst Posted
Study publicly available on registry
June 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedAugust 1, 2011
July 1, 2011
5.6 years
May 26, 2008
July 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Haemoglobin A1c after one year
1 year
Secondary Outcomes (7)
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
1 year
therapy-satisfaction (questionnaire)
1 year
changes of the antidiabetic therapy
1 year
- +2 more secondary outcomes
Study Arms (4)
1
EXPERIMENTALNo blood-glucose self-control, no HbA1c
2
EXPERIMENTALBlood-glucose self-control, no HbA1c
3
EXPERIMENTALNo blood-glucose self-control, HbA1c
4
EXPERIMENTALBlood-glucose self-control, HbA1c
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 )
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deutsche Diabetes Gesellschaftlead
- Bayercollaborator
Study Sites (41)
Diabeteszentrum Bad Lauterberg
Bad Lauterberg im Harz, Lower Saxony, D-37431, Germany
Koch, Peter
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
Related Publications (1)
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.
PMID: 24445534DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael A. Nauck, Prof. Dr.
Diabeteszentrum Bad Lauterberg
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 26, 2008
First Posted
June 2, 2008
Study Start
February 1, 2003
Primary Completion
September 1, 2008
Study Completion
December 1, 2008
Last Updated
August 1, 2011
Record last verified: 2011-07