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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN79164268

Enrollment

400

Registered

2005-10-28

Start date

2003-12-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes

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 we

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
HbA1c six months after start of the study	—

Secondary

Measure	Time frame
1. Hypoglycaemia with necessary outside help 2. Hyperosmolar coma 3. Quality of life 4. Compliance 5. HbA1c after 12 months	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026