To evaluate the accuracy of trained hypo-alert dogs and to evaluate the quality of life of patients with such a dog.
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
percentage of adequately alerted hypoglycemias by the dog during the
observation periods
Secondary outcome
quality of life
Background summary
hypoglycemia unawareness is a serious problem in more than 25 percent of
patients with longstanding diabetes type 1. Until now there are no solutions
for this problem. A dog is able to sense hypoglycemia in his master and can be
trained to alert his master. A observation with one patient has proven that
this concept can work.
Study objective
To evaluate the accuracy of trained hypo-alert dogs and to evaluate the quality
of life of patients with such a dog.
Study design
8 patients who will betrained with a hypo-alert dog will be tested with
contineous glucose monitoring for 3 days, before , during and after the
training. Data from the cgm, which will be blinded during the study period will
be correlated to the reaction of the dog and the self measured blood glucose
values of the patients. Questionaries concerning hypo-fear and quality of life
will be filled by the patients before, during and after the training period
Study burden and risks
CGM will be some kind of burden for the patients, while having to wear a sensor
for three days at a row and inserting a subcutaneous needle.
No clear risks are involved
H.Dunantweg 2
9834 AD
NL
H.Dunantweg 2
9834 AD
NL
Listed location countries
Age
Inclusion criteria
diabetic patients older than 18 years with hypoglycemia unawareness
Exclusion criteria
psychiatric problems
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 | NL30622.099.09 |