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Clinical Trial NCT06246578 for Type 1 Diabetes, Hypoglycemia is suspended. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Concordance of Hypoglycemia Measurement With Simultaneous Use of Two Devices for Continuous Glucose Measurement. 14
Clinical Trial NCT06246578 is an interventional study for Type 1 Diabetes, Hypoglycemia that is suspended. It started on January 19, 2024 with plans to enroll 14 participants. Led by Central Jutland Regional Hospital, it is expected to complete by May 1, 2026. The latest data from ClinicalTrials.gov was last updated on June 3, 2025.
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 h...Show More
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
Conditions
Type 1 DiabetesHypoglycemiaOther Study IDs
- 791575
NCT ID Number
Start Date (Actual)
2024-01-19
Last Update Posted
2025-06-03
Completion Date (Estimated)
2026-05-01
Enrollment (Estimated)
14
Study Type
Interventional
PHASE
N/A
Status
Suspended
Keywords
Hypoglycemia
Continuous glucose monitoring
Dexcom
Libre
Blood glucose
Continuous glucose monitoring
Dexcom
Libre
Blood glucose
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OtherWithin patient comparison Simultaneous glucose measurement with Libre 2 sensor and Contour Next One in patients using Dexcom G7 | 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 |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
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 |
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
Type 1 diabetes Using Dexcom G 7 -
Do not want to participate
-
Central Jutland Regional HospitalStudy Responsible Party
Klavs Würgler Hansen, Principal Investigator, Professor, Central Jutland Regional Hospital
No contact data.
1 Study Locations in 1 Countries
Silkeborg Regional Hospital, Silkeborg, 8600, Denmark