diabetes mellitus
Conditions
Interventions
Patients wear a new device that measures glucose.
Sponsors
Isala Klinieken
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - presence of type 1 DM; - age between 18 and 75 years old.
Exclusion criteria
Exclusion criteria: - A history of allergies towards (microneedle) patch substances/adhesive; - The inability to understand the Dutch language; - Oral of injected steroid using within the past 3 months - Pregnancy or planned pregnancy - Uncontrolled thyroid disease or hypertension - Poor visual acuity - Inability or unwillingness to meet the protocol requirements - 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 idi-CGM compared to Contour Plus Blue strip capillary measurement results during the 14-day study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include (i) accuracy of the idi-CGM compared to the Dexcom G6 rt-CGM during the 14-day study period, (ii) accuracy of the idi-CGM during the standardized meal test and (iii) usability and satisfaction with the idi-CGM. Accuracy will (primarily) 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