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

NCT ID: NCT06246578

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-19

Study Completion Date

2026-05-01

Brief Summary

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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

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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

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Type 1 Diabetes Hypoglycemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Within patient comparison

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

Group Type OTHER

Continuos glucose monitoring and blood glucose measurement

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Type 1 diabetes Using Dexcom G 7 -

Exclusion Criteria

Do not want to participate

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Jutland Regional Hospital

OTHER

Sponsor Role lead

Responsible Party

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Klavs Würgler Hansen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klavs W Hansen, MD

Role: STUDY_DIRECTOR

Silkeborg Regional Hospital

Locations

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Silkeborg Regional Hospital

Silkeborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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791575

Identifier Type: -

Identifier Source: org_study_id

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