Validation Freestyle continuous registration of glucose for the purpose of safe and correct use in the Netherlands

Validation Freestyle continuous registration of glucose for the purpose of safe and correct use in the Netherlands - Validation Freestyle-Libre

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42315

Enrollment

Registered

2015-03-06

Start date

2015-08-17

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Diabetes

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 18-75 jaar 10 non-DM, 10 T1DM, 10 T2DM in a stable situation Able to undergo the required controls and to fill in the questionnaires proposed Able to perform general daily activities

Exclusion criteria

Exclusion criteria: Unable to understand the study information or the Dutch language A condition that makes the health situation unstable or which results in the short term to serious deterioration or death. Chrnisch gebruik van hoge doses paracetamol en / of vitamine C

Design outcomes

Primary

Measure	Time frame
1. Validate the Abbott Freestyle-Libre glucose measurement technique used on verious insertion sites, by comparing its outcomes with another continuous glucose monitoring (CGM) technique and laboratory testing as the golden standard for glucose measurement.	—

Secondary

Measure	Time frame
1. Comparing the use of the Freestyle Libre between insertion in the upper arm and abdominal insertion (currently the Freestyle Libre is only tested after insertion into the upper arm, comparative data on other places where this device can be inserted are missing) 2. Study the glucose values after eating a meal using the Freestyle Libre and venous measurements (meal clamp technique) 3. Study the influence of the use of paracetamol and vitamin C on the reliability of the Freestyle libre results.	—

Measure

Time frame

1. Comparing the use of the Freestyle Libre between insertion in the upper arm and abdominal insertion (currently the Freestyle Libre is only tested after insertion into the upper arm, comparative data on other places where this device can be inserted are missing) 2. Study the glucose values after eating a meal using the Freestyle Libre and venous measurements (meal clamp technique) 3. Study the influence of the use of paracetamol and vitamin C on the reliability of the Freestyle libre results.

—

Countries

Netherlands

Outcome results