NCT06246578

Concordance of Hypoglycemia Measurement With Simultaneous Use of Two Devices for Continuous Glucose Measurement.

Concordance of Hypoglycemia Measurement in People With Type 1 Diabetes, With Simultaneous Use of Two Devices for Continuous Glucose Measurement: Abbott Freestyle Libre 2 and Dexcom G7

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Central Jutland Regional Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare two frequently used sensors for continuous glucose monitoring (CGM); Freestyle Libre and Dexcom G 7. More precisely, the investigators want to investigate if there is any difference in the hypoglycemic range for these two devices.

Detailed description

The investigators are including adults with type 1 diabetes who already are using a Dexcom G 7, in their diabetes treatment. Simultaneously with their Dexcom G7, the participants will get the Libre 2 sensor attached, and are to wear this for a period of 14 days. The Libre sensor is a Freetsyle Libre 2. Glucose data are compared for paired values within a time interval of 5 min or less. In this way the investigators have access to nearly simultaneous glucose values from two different CGM's. In addition, the participants are given a Contour Next One, and are asked to measure their blood glukose with fingerprick if their Dexcom registers a glucose value \< 5 mmol/l. By this project, we hope to gain more precise information about the two most widely distributed CGMs, and their function in the hypoglycemic area. This, can have impact on healthcare professionals' future therapeutic instructions, regarding the use of insulin adjustment and carbohydrate compensation.

Conditions

• Type 1 Diabetes
• Hypoglycemia

Interventions

Type	Name	Description
DEVICE	Continuos glucose monitoring and blood glucose measurement	The individuals who use Dexcom G 7 sensors for continous glucose monitoring is in addition applied a Libre 2 sensor and asked to wear both sensors for 14 days. In case of a Dexcom glucose value \< 5 mmol/l, the participants is aked to measure a blood glucose as well uising fingerprick and Contour Next One

Timeline

• Start date: 2024-01-19
• Primary completion: 2026-01-01
• Completion: 2026-05-01
• First posted: 2024-02-07
• Last updated: 2025-06-03

Locations

1 site across 1 country: Denmark