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 |
| Protocol serial number | N/A |
| Sponsor | Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) |
| Funder | Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) - Germany - 01GL0303 |
- 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
Scientific
Deutsches Diabetes Zentrum an der Heinrich-Heine-Universität
Auf´m Hennekamp 65
Duesseldorf
40225
Germany
| Phone | +49 (0)2113382-200 |
|---|---|
| scherbaum@ddz.uni-duesseldorf.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
HbA1c six months after start of the study |
| Key secondary outcome measure(s) |
1. Hypoglycaemia with necessary outside help |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 400 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2003 |
| Date of final enrolment | 01/10/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Deutsches Diabetes Zentrum an der Heinrich-Heine-Universität
Duesseldorf
40225
Germany
40225
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
