To assess the effects and the cost effectiveness of self monitoring of glucose in DM2 patients who are not using insulin on diabetes related distress, glycaemic control and changes in behavioural determinants.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Baseline measurements and follow-up measurements (after 6 and 12 months) are
used to explore short-term and long-term effects. Primary outcome measurements
will be assessed in terms of change in diabetes related distress and in
glycaemic control (HbA1c).
Secondary outcome
Secundary outcome measurements will be assessed in terms of change in
behavioural determinants, change in patient satisfaction and in changes in
lifestyle factors (dietary behaviour and physical activity). An economic
evaluation will be performed after 12 months from the societal perspective and
from the perspective of the health insurer.
Background summary
The percentage of patients with diabetes mellitus type 2 (DM2) is growing
rapidly. This is partly due to the ageing population, changes in lifestyle and
the resulting epidemic of obesity. DM2 imposes a significant burden on
patients* quality of life, and number of healthy life years due to both
microvascular and macrovascular complications. By sustaining a good glucose
control the onset of these complications can be delayed and its progression
reduced. Self monitoring of glucose can aid in diabetes control by giving the
patient the ability to make appropriate day-to-day treatment choices in diet
and physical activity. It is hypothesized that self-monitoring of glucose will
motivate DM2 patients to become active participants in their own care leading
to a reduce in diabetes related distress and an increased glucose control.
Study objective
To assess the effects and the cost effectiveness of self monitoring of glucose
in DM2 patients who are not using insulin on diabetes related distress,
glycaemic control and changes in behavioural determinants.
Study design
This 3-armed randomized clinical trial will be implemented in the structured
Diabetes Management System West Friesland (DMS). Six-hundred patients with DM2
will be recruited and randomised into respectively 3 groups (n=200 per group);
Self Monitoring of Blood Glucose (SMBG), Self Monitoring of Urine Glucose
(SMUG) and usual care.
Intervention
All 3 groups will receive standardized usual diabetes care conform the DMS. The
intervention groups will receive additional instructions on how to use and
interpret respectively SMBG or SMUG.
Study burden and risks
Not applicable
van der Boechorststraat 7
1081 BT AMSTERDAM
NL
van der Boechorststraat 7
1081 BT AMSTERDAM
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN84568563 |
| CCMO | NL19594.029.07 |