Energy expenditure and (assessment of) glucose regulation of participants with diabetes mellitus during and after the Camino SENSOR-D-4

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON20112

Enrollment

Registered

2019-08-01

Start date

2019-08-01

Completion date

Unknown

Last updated

2024-02-28

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

Eligibility

Inclusion criteria

Inclusion criteria: Subjects with type 1 or type 2 diabetes mellitus, using insulin either by MDI or by CSII Being fit enough to participate in the Bas van de Goor Foundation “we hike to change diabetes” challenge in September 2019. 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 hike challenge but abstain from participating

Design outcomes

Primary

Measure	Time frame
Study a TEE, BEE and AEE and the degree of prevalent and chronic glucose control when analyzing DG6 Study b Time in hypoglycemia, normo- and in hyperglycemia when analyzing DG6 during exercise (with and without using the buddy function) Study c Endpoints A: Time in hypoglycemia, normo- and in hyperglycemia both when analyzing DG6 separately and when comparing both devices; separate analysis of performance during exercise and during resting state B: MAD and MARD of registered glucose concentrations, taking the capillary measurements as reference value, again both during exercise and during resting state C: Parkes Error grids (ISO15197:2013) using the capillary measurements as the reference values, during exercise and during resting state D: Satisfaction with and usability of the devices, especially during exercise	—

Measure

Time frame

Study a TEE, BEE and AEE and the degree of prevalent and chronic glucose control when analyzing DG6 Study b Time in hypoglycemia, normo- and in hyperglycemia when analyzing DG6 during exercise (with and without using the buddy function) Study c Endpoints A: Time in hypoglycemia, normo- and in hyperglycemia both when analyzing DG6 separately and when comparing both devices; separate analysis of performance during exercise and during resting state B: MAD and MARD of registered glucose concentrations, taking the capillary measurements as reference value, again both during exercise and during resting state C: Parkes Error grids (ISO15197:2013) using the capillary measurements as the reference values, during exercise and during resting state D: Satisfaction with and usability of the devices, especially during exercise

—

Contacts

Public ContactMarion Fokkert

Isala Zwolle

m.j.fokkert@isala.nl038/4242476

Outcome results