Type 1 Diabetes MellitusNCT03602963
Comparison Between Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System and the FreeStyle Libre Flash Glucose Monitoring System
An observational study of Type 1 Diabetes Mellitus, run by Jessa Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Dexcom G5 Mobile CGM system
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Jul 2018to 30 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with type 1 diabetes mellitus treated with insulin injections
Who may be able to join
- Type 1 diabetes mellitus
- Treated by insulin injections
Who cannot join
- Other types of diabetes
- Treated with insulin pump
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study on the Accuracy and Usability Between the Dexcom G5 Mobile CGM System and the FreeStyle Flash Glucose Monitoring System
- 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.
- Patient satisfaction will be evaluated using a questionnaire that will be completed after the Dexcom G5 sensor has been worn for 1 month.
- 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Dexcom G5 Mobile CGM system
- Keywords
- Diabetes Mellitus, Child, Glucose sensor, Accuracy, Usability
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G5 Mobile CGM systemDevice
The accuracy and usability ot the Dexcom G5 mobile CGM system will be evaluated
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Dexcom G5 Mobile CGM system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the Dexcom G5 mobile continuous glucose monitoring (CGM) system by comparison of sensor glucose measurements with capillary blood glucose determinations
Comparison of sensor glucose measurements will be compared with capillary blood glucose measurements at least 4 times a day
Measured: 2 weeks
Secondary outcomes (1)
Patients' and parents' satisfaction with the Dexcom G5 mobile CGM system will be evaluated by a standardized questionnaire
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).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start9 Jul 2018
- Primary completion31 Dec 2018
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guy Massa, MD, PhD, Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602963
- Sponsor's protocol ID
- JessaH_18.64/ped18.02
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on the Accuracy and Usability Between the Dexcom G5 Mobile CGM System and the FreeStyle Flash Glucose Monitoring System
- ClinicalTrials.gov ID
- NCT03602963
- Acronym / sponsor ID
- JessaH_18.64/ped18.02
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Child, Glucose sensor, Accuracy, Usability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- Patient satisfaction will be evaluated using a questionnaire that will be completed after the Dexcom G5 sensor has been worn for 1 month.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexcom G5 mobile CGM system | – | Device: Dexcom G5 Mobile CGM systemChildren (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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with type 1 diabetes mellitus treated with insulin injections
Key inclusion criteria (2 listed)
- Type 1 diabetes mellitus
- Treated by insulin injections
Key exclusion criteria (2 listed)
- Other types of diabetes
- Treated with insulin pump
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexcom G5 Mobile CGM systemThe accuracy and usability ot the Dexcom G5 mobile CGM system will be evaluated | Device | Dexcom G5 mobile CGM system |
Primary outcome
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
1 secondary outcome
Patients' and parents' satisfaction with the Dexcom G5 mobile CGM system will be evaluated by a standardized questionnaire
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Massa, MD, PhD principal investigator
Jessa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.