Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/09/2005
Date assigned
28/10/2005
Last edited
09/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

Results: http://www.ncbi.nlm.nih.gov/pubmed/18769484

Publication citations

  1. 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.

Additional files

Editorial Notes