Evaluation of the necessary frequency of blood glucose self-monitoring in type 2 diabetic patients. A prospective, controlled, randomised, multicenter study.

ISRCTN ISRCTN79164268
DOI https://doi.org/10.1186/ISRCTN79164268
Secondary identifying numbers N/A
Submission date
05/09/2005
Registration date
28/10/2005
Last edited
09/09/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Werner A. Scherbaum
Scientific

Deutsches Diabetes Zentrum an der Heinrich-Heine-Universität
Auf´m Hennekamp 65
Duesseldorf
40225
Germany

Phone +49 (0)2113382-200
Email scherbaum@ddz.uni-duesseldorf.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedType 2 diabetes mellitus
InterventionBlood 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 typeOther
Primary outcome measureHbA1c six months after start of the study
Secondary outcome measures1. Hypoglycaemia with necessary outside help
2. Hyperosmolar coma
3. Quality of life
4. Compliance
5. HbA1c after 12 months
Overall study start date01/12/2003
Completion date01/10/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants400 (100 in each group)
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/12/2003
Date of final enrolment01/10/2006

Locations

Countries of recruitment

  • Germany

Study participating centre

Deutsches Diabetes Zentrum an der Heinrich-Heine-Universität
Duesseldorf
40225
Germany

Sponsor information

Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
Government

Südstrasse 125
Bonn
53175
Germany

Phone +49 (0)2283821202
Email cornelia.bormann@dlr.de
ROR logo "ROR" https://ror.org/04pz7b180

Funders

Funder type

Government

Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) - Germany - 01GL0303

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results: 28/08/2008 Yes No