Effect of self-monitoring of glucose in non-insulin treated patients with type 2 diabetes.

The effect of self monitoring of blood glucose and urine glucose relative to usual care without self monitoring on diabetes related distress and glycaemic control in patients with type 2 diabetes who are not using insulin.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27291

Enrollment

600

Registered

2006-10-19

Start date

2007-07-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Diabetes Mellitus type 2

Interventions

A stratified, randomized 6-arm clinical trial among DM2 patients with a Hb1Ac of 7.0% or above who are not using insulin. Eligible and consenting subjects will be randomly assigned to the intervention

the intervention groups and the control group will receive a standardised treatment program to change their diet and lifestyle. In addition, patients in the SMBG group will be educated to use the SMBG

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1. Problem areas in diabetes scale (PAID) assessed at baseline and at 6 and 12 months after inclusion; 2. Glycaemic control measured by glycated haemoglobin concentration (HbA1c-level) at baseline and at 6 and 12 after inclusion; 3. cost-effectiveness assessed using cost-diaries and the EuroQol.	—

Secondary

Measure	Time frame
1. Frequency and severity of hypoglycaemia; 2. Change in well-being: Well being questionnaire (W-BQ12); 3. Patient satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQ); 4. Changes in lifestyle factors: diet behaviour (Dutch Eating Behaviour Questionnaire (DEBQ)); physical activity (Short Questionnaire to Assess Health Enhancing Physical Activity (SQUASH)); 5. Changes in medication use; 6.Compliance; 7. Medical care utilization.	—

Measure

Time frame

1. Frequency and severity of hypoglycaemia; 2. Change in well-being: Well being questionnaire (W-BQ12); 3. Patient satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQ); 4. Changes in lifestyle factors: diet behaviour (Dutch Eating Behaviour Questionnaire (DEBQ)); physical activity (Short Questionnaire to Assess Health Enhancing Physical Activity (SQUASH)); 5. Changes in medication use; 6.Compliance; 7. Medical care utilization.

—

Contacts

Public ContactU.L. Malanda

VU Medisch Centrum Amsterdam EMGO-Instituut Afdeling Huisartsgeneeskunde

u.malanda@vumc.nl+31 20 444 8395

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)