Effect of self-monitoring of glucose in non-insulin treated patients with type 2 diabetes.
- Conditions
- Diabetes Mellitus type 2
- Registration Number
- NL-OMON27291
- Lead Sponsor
- VU University Medical Center, EMGO-Institute
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 600
Inclusion Criteria
1. All patients are participants of the Diabetes Care System West-Friesland;
2. Patients with type 2 diabetes with HbA1c levels of 7,0% or above who are not using insulin;
3. Younger than 76 year;
4. Known disease duration of over 1 year; 5. Not used self monitoring of glucose in the previous year.
Exclusion Criteria
1. Severe complications of diabetes;
2. Pregnant women;
3. Unable to carry out self monitoring of glucose;
4. Unable to fill in questionnaires/diaries.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Problem areas in diabetes scale (PAID) assessed at baseline and at 6 and 12 months after inclusion;<br>2. Glycaemic control measured by glycated haemoglobin concentration (HbA1c-level) at baseline and at 6 and 12 after inclusion;<br>3. cost-effectiveness assessed using cost-diaries and the EuroQol.
- Secondary Outcome Measures
Name Time Method 1. Frequency and severity of hypoglycaemia;<br>2. Change in well-being: Well being questionnaire (W-BQ12);<br>3. Patient satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQ);<br>4. Changes in lifestyle factors: diet behaviour (Dutch Eating Behaviour Questionnaire (DEBQ)); physical activity (Short Questionnaire to Assess Health Enhancing Physical Activity (SQUASH));<br>5. Changes in medication use;<br>6.Compliance;<br>7. Medical care utilization.