The effects of self-monitoring of glucose in non-insulin treated patients with type 2 diabetes
Recruiting
- Conditions
- 10018424Diabetes type 2
- Registration Number
- NL-OMON31259
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 600
Inclusion Criteria
-DM2 patients treated with diet and/or oral hypoglycaemic agents
-Not requiring insulin at inclusion
-HbA1c><= 7.0%
-Known disease duration of over 1 Year
-Not used self monitoring of blood glucose or urine glucose in the previous year
-Age between 45 and 75 years
Exclusion Criteria
-Severe complications of diabetes
-Unable to carry out SMBG or SMUG
-Unable to fill in questionnaires/diaries
-Unable to understand the Dutch language
-Circumstances likely to interfere with all measurements
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Baseline measurements and follow-up measurements (after 6 and 12 months) are<br /><br>used to explore short-term and long-term effects. Primary outcome measurements<br /><br>will be assessed in terms of change in diabetes related distress and in<br /><br>glycaemic control (HbA1c). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary outcome measurements will be assessed in terms of change in<br /><br>behavioural determinants, change in patient satisfaction and in changes in<br /><br>lifestyle factors (dietary behaviour and physical activity). An economic<br /><br>evaluation will be performed after 12 months from the societal perspective and<br /><br>from the perspective of the health insurer.</p><br>