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

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ClinicalTrials.gov Identifier: NCT03602963
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Jessa Hospital

Brief Summary:
  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.

Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Device: Dexcom G5 Mobile CGM system

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparative Study on the Accuracy and Usability Between the Dexcom G5 Mobile CGM System and the FreeStyle Flash Glucose Monitoring System
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Device: Dexcom G5 Mobile CGM system
The accuracy and usability ot the Dexcom G5 mobile CGM system will be evaluated




Primary Outcome Measures :
  1. Accuracy of the Dexcom G5 mobile continuous glucose monitoring (CGM) system by comparison of sensor glucose measurements with capillary blood glucose determinations [ Time Frame: 2 weeks ]
    Comparison of sensor glucose measurements will be compared with capillary blood glucose measurements at least 4 times a day


Secondary Outcome Measures :
  1. Patients' and parents' satisfaction with the Dexcom G5 mobile CGM system will be evaluated by a standardized questionnaire [ Time Frame: 1 month ]
    Patients' and parents' satisfaction with the Dexcom G5 mobile CGM system will be evaluated by a standardized questionnaire after 1 month of sensor wear. Patients and parents will rate their experience with the Dexcom G5 mobile CGM system on a scale of 1 (strongly agree) to 5 (strongly disagree). There are three questions about sensor application (e.g. It is easy to put the sensor on) and eleven questions about the wearing of the sensor (e.g. The sensor doesn't disturb me for sporting).



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with type 1 diabetes mellitus treated with insulin injections
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus
  • Treated by insulin injections

Exclusion Criteria:

  • Other types of diabetes
  • Treated with insulin pump

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602963


Contacts
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Contact: Guy G Massa, MD, PhD +3211337375 guy.massa@jessazh.be
Contact: Renate Zeevaert, MD, PhD +3211337376 renate.zeevaert@jessazh.be

Locations
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Belgium
Jessa Hospital Recruiting
Hasselt, Limburg, Belgium, B3500
Contact: Guy G Massa, MD, PhD    +3211309866    guy.massa@jessazh.be   
Contact: Renate Zeevaert, MD, PhD       renate.zeevaert@jessazh.be   
Sponsors and Collaborators
Jessa Hospital
Investigators
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Principal Investigator: Guy Massa, MD, PhD Jessa Hospital

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Responsible Party: Jessa Hospital
ClinicalTrials.gov Identifier: NCT03602963     History of Changes
Other Study ID Numbers: JessaH_18.64/ped18.02
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Jessa Hospital:
Diabetes Mellitus
Child
Glucose sensor
Accuracy
Usability

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases