Status:
COMPLETED
Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control
Lead Sponsor:
Deutsche Diabetes Gesellschaft
Collaborating Sponsors:
Bayer
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
40-80 years
Phase:
PHASE4
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 effect...
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 yea...
Eligibility Criteria
Inclusion
- 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
- 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 )
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00688363
Start Date
February 1 2003
End Date
December 1 2008
Last Update
August 1 2011
Active Locations (41)
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1
Diabeteszentrum Bad Lauterberg
Bad Lauterberg im Harz, Lower Saxony, Germany, D-37431
2
Koch, Peter
Bad Harzburg, Germany, 38667
3
Maxeiner, Stefan
Bad Kreuznach, Germany, 55545
4
Friedrichs, Michael
Bad Lauterberg im Harz, Germany, 37431