Effect of self-monitoring of glucose in non-insulin treated patients with type two diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus type two (DM2); Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN84568563
• Lead Sponsor: Vrije University Medical Centre (VUMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-02
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. All patients are participants of the Diabetes Care System West-Friesland
2. Patients with type two diabetes with HbA1c levels of 7.0% or above who are not using insulin
3. Younger than 76 years
4. Known disease duration of over one 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 months after inclusion<br>3. Cost-effectiveness assessed using cost-diaries and the European Quality of Life (EuroQoL) questionnaire

Secondary Outcome Measures

Name	Time	Method
1. Frequency and severity of hypoglycaemia<br>2. Change in well-being: 12-item Well Being Questionnaire (WBQ-12)<br>3. Patient satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQ)<br>4. Changes in lifestyle factors: <br>a. diet behaviour (Dutch Eating Behaviour Questionnaire [DEBQ])<br>b. physical activity (Short Questionnaire to Assess Health enhancing physical activity [SQUASH])<br>5. Changes in medication use<br>6. Compliance<br>7. Medical care utilisation<br><br>All secondary outcomes will be assessed at baseline, 6 and 12 months after inclusion.