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Performance of the GlucoMen® Day CGM (WaveForm Cascade) Continuous Glucose Monitor (CGM) during strenuous, extreme exercise conditions in subjects with type 1 diabetes mellitus

Performance of the GlucoMen® Day CGM (WaveForm Cascade) Continuous Glucose Monitor (CGM) during strenuous, extreme exercise conditions in subjects with type 1 diabetes mellitus - Performance of the GlucoMen® Day CGM during strenuous exercise conditions

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49340
Enrollment
14
Registered
2020-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Interventions

None listed

Sponsors

Isala Klinieken
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subjects with type 1 diabetes mellitus, using insulin either by MDI or by CSII Being fit enough to participate in the Bas van de Goor Foundation *we bike to change diabetes* challenge in 2020* and willing to spend a week in resting conditions in the week after the challenge.

Exclusion criteria

Exclusion criteria: Those subjects who participate in the MTB challenge but abstain from participating

Design outcomes

Primary

MeasureTime frame
Endpoints A: Time in hypoglycemia, normo- and in hyperglycemia when comparing SMBG with MWF-CGM; separate analysis of performance during strenuous exercise and during resting state B: MAD and MARD of registered glucose concentrations, taking the capillary measurements as reference value, again both during strenuous exercise and during resting state C: Parkes Error grids (ISO15197:2013) using the capillary measurements as the reference values, during strenuous exercise and during resting state D: satisfaction with and usability of the device, especially during strenuous exercise

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)