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02 September 2010
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| [ Print-friendly version ] |
| Evaluation of the necessary frequency of blood glucose self-monitoring in type 2 diabetic patients. A prospective, controlled, randomised, multicenter study. |
| ISRCTN | ISRCTN79164268 |
| ClinicalTrials.gov identifier | |
| Public title | Evaluation of the necessary frequency of blood glucose self-monitoring in type 2 diabetic patients. A prospective, controlled, randomised, multicenter study. |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N/A |
| 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 |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Type 2 diabetes mellitus |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/12/2003 |
| Anticipated end date | 01/10/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 400 (100 in each group) |
| Interventions |
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 |
| Primary outcome measure(s) | HbA1c six months after start of the study |
| Secondary outcome measure(s) |
1. Hypoglycaemia with necessary outside help
2. Hyperosmolar coma 3. Quality of life 4. Compliance 5. HbA1c after 12 months |
| Sources of funding | Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) - Germany - 01GL0303 |
| Trial website | |
| Publications | Results: http://www.ncbi.nlm.nih.gov/pubmed/18769484 |
| Contact name | Prof Werner A. Scherbaum |
| Address |
Deutsches Diabetes Zentrum an der Heinrich-Heine-Universität
Auf´m Hennekamp 65 |
| City/town | Duesseldorf |
| Zip/Postcode | 40225 |
| Country | Germany |
| Tel | +49 (0)2113382-200 |
| Fax | +49 (0)2113369103 |
| scherbaum@ddz.uni-duesseldorf.de | |
| Sponsor | Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) |
| Address | Südstrasse 125 |
| City/town | Bonn |
| Zip/Postcode | 53175 |
| Country | Germany |
| Tel | +49 (0)2283821202 |
| Fax | +49 (0)2283821257 |
| cornelia.bormann@dlr.de | |
| Date applied | 05/09/2005 |
| Last edited | 09/09/2008 |
| Date ISRCTN assigned | 28/10/2005 |
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| © 2010 ISRCTN unless otherwise stated. | |
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