The objective is to investigate whether the 1e or 2e drop of blood can be used during the capillary glucose monitoring. The influence of a soiled finger and venous stasis are investigated.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The capillairy glucose value of the 1e and the 2e drop of blood will be
compared to the control capillairy glucose value. A difference more than 10 %
is relevant. Of the testresults 95 % must be < 10 % difference.
Secondary outcome
Lead not washing the hands, venous stasis of fingers soiled with fruit more
often to more than 10 % difference compared to capillairy glucose values with
clean hands.
Clarke Error Grid analysis will be used to investigate in how many cases the
outcome will lead to another interpretation and/or action. The patients with
diabetes type 1 and type 2 will be separately investigated.
Background summary
Self-monitoring of blood glucose (SMBG) is an important tool in the management
of diabetes mellitus. Patients with diabetes and insulin treatment assess their
blood glucose level to evaluate and, if necessary, to adjust insulin treatment
and lifestyle, and to detect hypoglycemia.
Recently a discussion started in The Netherlands about the use of the 1e or 2e
drop of blood during SMBG. This study investigate whether the 1e drop or the 2e
drop of blood can be used during SMBG conducted by the patients with diabetes.
Study objective
The objective is to investigate whether the 1e or 2e drop of blood can be used
during the capillary glucose monitoring. The influence of a soiled finger and
venous stasis are investigated.
Study design
The control capillairy glucose value is measured on each finger which is used
during the study. Capillairy glucose values are measured when the patient has
not washed his/her hands, when the patient has washed his/her hands, when the
fingers are soiled with different kind of fruit (apple and banana) en during
venous stasis. The Accu-Chek Compact plus bloodglucose meter is used. The study
is conducted by the investigator in the laboratory of the Isala Clinics.
Intervention
Intervention is capillairly glucosemeasurement in the following situations:
1. the patient has not washed his or her hands
2. the patient has washed his or her hands
3. the fingers are soiled with different kind of fruit: apple and banana
4. venous stasis
Study burden and risks
SMBG is regurarly done by patients with diabetes. Laboratory values and general
information are distracted from the medical report. The patients are asked
several questions about their SMBG.
Dokter Spanjaardweg 11
8025 BT Zwolle
Nederland
Dokter Spanjaardweg 11
8025 BT Zwolle
Nederland
Listed location countries
Age
Inclusion criteria
patients with type 1 or type 2 diabetes and treatment with insulin and who visit the laboratory of the Isala Clinics
age > 18 year
Exclusion criteria
dialysis patients
Design
Recruitment
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 | NL27336.075.09 |