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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246578
• Other study ID #: 791575
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: Central Jutland Regional Hospital
• Contact: Mia Christensen, MD
• Phone: +45 60144864
• Email: MIACHT[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: August 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Type 1 diabetes Using Dexcom G 7 - Exclusion Criteria: Do not want to participate -

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
Denmark	Silkeborg Regional Hospital	Silkeborg

Sponsors (1)

Lead Sponsor	Collaborator
Central Jutland Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between paired blood glucose values and simultaneous Dexcom and Libre glucose values	Difference between paired blood glucose values and simultaneous CGM values for Dexcom and Libre for Dexcom values < 5 mmol/l	5 minutes or less between the glucose values compared
Primary	Difference between paired Dexcom and Libre glucose values	Difference between paired simultaneous CGM value for Dexcom and Libre for all measured glucose values.	5 minutes or less between the glucose values compared