The objective of the study is to:- explore views of patients with type 1 or type 2 diabetes about SMBG- investigate the associations between demographic aspects, biological aspects, quality of life, adherence to SMBG and views of patients about SMBG…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Qulitative research: to develop a concept or 'new theory' which descripes the
diabetic patient's view about SMBG.
Quantitative research: A description of associations between patients'
characteristics, quality of life and patient's view about SMBG. The 'new
theory' will further be tested.
Secondary outcome
not applicable
Background summary
Self monitoring of blood glucose (SMBG) is an important factor in achieving
optimal glycemic control. Blood glucose monitoring results provide guidelines
for meal planning, exercise and medication use. Adherence to glucose
monitoring, investigated in several international studies, is suboptimal. In
The Netherlands there is attention to the performance of SMBG (technical
aspects). There is little attention to and limited information about patient's
views of the profits and the burden of SMBG. This study investigates the
experience with SMBG from the patient's view.
Study objective
The objective of the study is to:
- explore views of patients with type 1 or type 2 diabetes about SMBG
- investigate the associations between demographic aspects, biological aspects,
quality of life, adherence to SMBG and views of patients about SMBG
Study design
The study design consists of a qualitative and a quantitative study.
Qualitative research: the choosen method is Grounded Theory approach. We will
start with 2 focus groups. Followed by in-depth interviews with 20 type 1
diabetic patients and 20 type 2 diabetic patients. On the basis of the results
of this research a questionnaire will be developed about the patient's view
concerning SMBG.
Quantitative research: 100 subjects with type 1 diabetes and 100 subjects with
type 2 diabetes are asked to complete several validated questionnairies about
quality of life and self efficay and the new questionnaire about the patient's
view concerning SMBG. Demographic information and information about the health
status are collected from the medical report.
Study burden and risks
Talking or thinking about one's view about SMBG may cause psychological
burden.
Knowlegde of the view of patients about SMBG can help to design effective
disease management programs and to develope further clinical guidelines and
quality standards about SMBG.
Dokter Spanjaardweg 11
8025 BT Zwolle
NL
Dokter Spanjaardweg 11
8025 BT Zwolle
NL
Listed location countries
Age
Inclusion criteria
patients with type 1 or type 2 diabetes and treatment with insulin
age > 18 years
experience with injecting insulin and self monitoring of blood glucose for at least one year
Exclusion criteria
Poor command of the Dutch language
Patients with severe co-morbidity (physically and mentally)
pregnancy
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 |
---|---|
CCMO | NL27433.075.09 |