To determine the accuracy of the FSL in persons >= 70 years of age with diabetes (type 1 or type 2) as compared to routine capillary measurements and whole blood measurements.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the accuracy of the FSL-v2 compared to Contour blue
capillary measurement results during the 14-day study period.
Secondary outcome
Secondary outcomes are (i) the accuracy of the FSL during the standardized oral
glucose load test and (ii) the usability and satisfaction with the FSL.
Accuracy will be analysed as according to the guidelines for Integrated
Continuous Glucose Monitoring Approvals (Class II-510(K), (Parkes) error grid-,
bias (including MARD), correlation, stability and Bland-Altman analysis.
Background summary
For the optimal regulation of diabetes, frequent measurements of glucose levels
are essential in individuals who use insulin therapy. The Freestyle libre (FSL)
is a flash glucose monitoring system, which measures the glucose levels in the
interstitial fluid. It has been shown that the FSL improves glycemic control in
patients and reduces the burden of disease. Its accuracy has been determined in
earlier studies, however these studies included younger participants. However,
in practice, the elderly form an increasingly large proportion of the FSL
users, and with increased age, the interstitial space and fluid dynamics
change, possibly affecting performance. As such, there is need of a formal
assessment of accuracy of the FSL in the elderly population
Study objective
To determine the accuracy of the FSL in persons >= 70 years of age with diabetes
(type 1 or type 2) as compared to routine capillary measurements and whole
blood measurements.
Study design
Prospective non-randomized cohort study assessing the performance of the FSL
(version 2, Abbott Diabetes Care) as compared to the gold standard (capillary
measurements using Contour plus blue (Ascensia Diabetes Care). Measurements
will be performed during a 14-day study period which includes an in-clinic
visit to perform a standardized oral glucose load test.
Study burden and risks
Participants will be asked to wear the FSL glucose monitoring devices at once
and to measure their capillary blood glucose levels at regular intervals (at
least 4, but preferably 7 times daily). Also, participants will undergo a
4-hour in-hospital standardized oral glucose load test, during which blood will
be collected via an intravenous catheter.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Age >=70 years at time of inclusion
- Diabetes, type 1 or type 2
- Ability to provide oral and written informed consent
Exclusion criteria
- A history of allergies towards patch substances/adhesive;
- The inability to understand the Dutch language;
- Oral or injected steroid use within the past 3 months
- Uncontrolled thyroid disease or hypertension
- Poor visual acuity
- Inability or unwillingness to meet the protocol requirements, such as being
incapacitated
- Any severe or uncontrolled medical or psychological condition which, in the
opinion of the investigator, would compromise the ability to meet protocol
requirements.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83285.042.23 |