Comparison Between Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System and the FreeStyle Libre Flash Glucose Monitoring System

NCT ID: NCT03602963

Last Updated: 2020-02-17

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

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-09

Study Completion Date

2019-03-30

Brief Summary

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1. The accuracy of the sensors (Dexcom G5 vs FreeStyle Libre Flash glucose monitoring) will be evaluated by simultaneous wearing of the 2 sensors during 2 weeks. During these 2 weeks the patients will do at least four capillary blood glucose measurements to compare with the sensor results.
2. Patient satisfaction will be evaluated using a questionnaire that will be completed after the Dexcom G5 sensor has been worn for 1 month.
3. The data recorded by the FreeStyle Libre Flash glucose monitoring system (average glucose,% above target, % within target, % under target, amount of hypoglycemia) in the month prior to the 2 weeks of double sensor wear will be compared to the same data recorded by the Dexcom G5 mobile CGM system during the first month of use.

Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dexcom G5 mobile CGM system

Children (6 to 18 years) with type 1 diabetes mellitus treated with insulin injections and wearing a FreeStyle Libre Flash glucose sensor that will switch to the Dexcom G5 mobile glucose monitoring system.

Dexcom G5 Mobile CGM system

Intervention Type DEVICE

The accuracy and usability ot the Dexcom G5 mobile CGM system will be evaluated

Interventions

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Dexcom G5 Mobile CGM system

The accuracy and usability ot the Dexcom G5 mobile CGM system will be evaluated

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes mellitus
* Treated by insulin injections

Exclusion Criteria

* Other types of diabetes
* Treated with insulin pump
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jessa Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guy Massa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jessa Hospital

Locations

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Jessa Hospital

Hasselt, Limburg, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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JessaH_18.64/ped18.02

Identifier Type: -

Identifier Source: org_study_id

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