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

Not Applicable

Recruiting

• Conditions: Type 1 Diabetes; Hypoglycemia
• Interventions: Device: Continuos glucose monitoring and blood glucose measurement

• Registration Number: NCT06246578
• Lead Sponsor: Central Jutland Regional Hospital

Brief 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.

Study Timeline

• Study Start: 2024-01-19
• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-02-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2026-01-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Type 1 diabetes Using Dexcom G 7 -

Exclusion Criteria

Do not want to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Within patient comparison	Continuos glucose monitoring and blood glucose measurement	Simultaneous glucose measurement with Libre 2 sensor and Contour Next One in patients using Dexcom G7

Primary Outcome Measures

Name	Time	Method
Difference between paired blood glucose values and simultaneous Dexcom and Libre glucose values	5 minutes or less between the glucose values compared	Difference between paired blood glucose values and simultaneous CGM values for Dexcom and Libre for Dexcom values \< 5 mmol/l
Difference between paired Dexcom and Libre glucose values	5 minutes or less between the glucose values compared	Difference between paired simultaneous CGM value for Dexcom and Libre for all measured glucose values.

Trial Locations

Locations (1)

Silkeborg Regional Hospital; 🇩🇰 Silkeborg, Denmark