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

NCT06246578 | Suspended

• 1 other identifier: 791575
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Hypoglycemia

Keywords

Hypoglycemia; Continuous glucose monitoring; Dexcom; Libre; Blood glucose

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Within patient comparison

OTHER

Simultaneous glucose measurement with Libre 2 sensor and Contour Next One in patients using Dexcom G7

Device: Continuos glucose monitoring and blood glucose measurement

Interventions

Continuos glucose monitoring and blood glucose measurement DEVICE

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

Within patient comparison

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes Using Dexcom G 7 -

You may not qualify if:

• Do not want to participate

Sponsors & Collaborators

• Central Jutland Regional Hospital: lead

Study Sites (1)

Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Klavs W Hansen, MD

  Silkeborg Regional Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Comparison of nearly simultaneous interstitial glucose values obtained by Dexcom G 7 and Libre 2 sensors for continuous glucose monitoring and blood glucose measured with Contour Next one

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: January 19, 2024
• Primary Completion: January 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: At time of submitting the manuscript
• Access Criteria: on reasonable request

Locations

DK (1)