Diabetes mellitus
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is the accuracy of the FSL-v2 compared to Contour blue capillary measurement results during the 14-day study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed