Contact information
Type
Scientific
Primary contact
Prof Werner A. Scherbaum
ORCID ID
Contact details
Deutsches Diabetes Zentrum an der Heinrich-Heine-Universität
Auf´m Hennekamp 65
Duesseldorf
40225
Germany
+49 (0)2113382-200
scherbaum@ddz.uni-duesseldorf.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the impact of the frequency of blood glucose self-monitoring on glycaemic control (HbA1c and occurrence of hypoglycaemia) of type 2 diabetic patients. Currently there are no general recommendations on the frequency of self blood glucose monitoring in type 2 diabetics treated with a fixed insulin regime or oral antidiabetic medication. The study intends to compare over a follow-up period of 6 month patients with a high frequency of self-monitoring with those with a low frequency. This comparison is done separately for two groups of patients:
1. Treated with a fixed insulin regime
2. Treated with oral antidiabetic drugs only
Satisfaction with the recommended treatment is a secondary endpoint of the study.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Type 2 diabetes mellitus
Intervention
Blood glucose monitoring
1. Patients on insulin mixture:
1.1 Maximum recommendation: every day fasting, every second day before dinner, additional once a profile
1.2 Minimum recommendation: once a week a fasting blood glucose
2. Patients who get an oral antidiabetic:
2.1 Maximum recommendation: every second day a fasting blood glucose, once a week a blood sugar check before dinner
2.2 Minimum recommendation: one fasting blood glucose per week
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
HbA1c six months after start of the study
Secondary outcome measures
1. Hypoglycaemia with necessary outside help
2. Hyperosmolar coma
3. Quality of life
4. Compliance
5. HbA1c after 12 months
Overall trial start date
01/12/2003
Overall trial end date
01/10/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients treated with a fixed dose of mixture insulin twice a day
2. Patients who are treated with one or more oral antidiabetic drugs
3. From 35 to 80 years
4. Informed consent
5. Type 2 diabetic patients
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400 (100 in each group)
Participant exclusion criteria
1. Treatment with multiple insulin injections (more than 2/day)
2. Type 1 diabetic patients
3. Advanced renal insufficiency (known creatinine >2.5 mg/dl)
4. >2 hypoglycaemia with necessary outside help within the last three months
5. Hypoglycaemic shock/hyperosmolaric coma within the last three months
6. Pregnancy
7. Severe impaired vision
8. Communication problems
9. Home care/nursing service
Recruitment start date
01/12/2003
Recruitment end date
01/10/2006
Locations
Countries of recruitment
Germany
Trial participating centre
Deutsches Diabetes Zentrum an der Heinrich-Heine-Universität
Duesseldorf
40225
Germany
Sponsor information
Organisation
Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
Sponsor details
Südstrasse 125
Bonn
53175
Germany
+49 (0)2283821202
cornelia.bormann@dlr.de
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) - Germany - 01GL0303
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results: http://www.ncbi.nlm.nih.gov/pubmed/18769484
Publication citations
-
Results
Scherbaum WA, Ohmann C, Abholz HH, Dragano N, Lankisch M, Effect of the frequency of self-monitoring blood glucose in patients with type 2 diabetes treated with oral antidiabetic drugs-a multi-centre, randomized controlled trial., PLoS ONE, 2008, 3, 8, e3087, doi: 10.1371/journal.pone.0003087.