Type 1 DiabetesNCT06246578
Concordance of Hypoglycemia Measurement With Simultaneous Use of Two Devices for Continuous Glucose Measurement.
A study testing Continuos glucose monitoring and blood glucose measurement in people with Type 1 Diabetes and Hypoglycemia, run by Central Jutland Regional Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia
- What is being tested?
- Continuos glucose monitoring and blood glucose measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Jan 2024to 1 May 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 1 diabetes Using Dexcom G 7 -
Who cannot join
- Do not want to participate
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concordance of Hypoglycemia Measurement in People With Type 1 Diabetes, With Simultaneous Use of Two Devices for Continuous Glucose Measurement: Abbott Freestyle Libre 2 and Dexcom G7
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.
Read the detailed description
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
- Type 1 Diabetes, Hypoglycemia
- Being tested
- Continuos glucose monitoring and blood glucose measurement
- Keywords
- Hypoglycemia, Continuous glucose monitoring, Dexcom, Libre, Blood glucose
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuos glucose monitoring and blood glucose measurementDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Within patient comparison | Other | Simultaneous glucose measurement with Libre 2 sensor and Contour Next One in patients using Dexcom G7 Receives: Device: Continuos glucose monitoring and blood glucose measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 5 minutes or less between the glucose values compared
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start19 Jan 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 May 2026 (estimated)
Why it stopped: Recent published work comparing different sensors has outdated our study. It is meaningless to continue to compare "old" sensors, which are updated to never version with different performance.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klavs Würgler Hansen, Central Jutland Regional Hospital
- Investigators
- Klavs W Hansen, MD, Study director, Silkeborg Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246578
- Sponsor's protocol ID
- 791575
- Status last verified
- May 2025
- First submitted
- 30 Jan 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Date, time and glucose values
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance of Hypoglycemia Measurement in People With Type 1 Diabetes, With Simultaneous Use of Two Devices for Continuous Glucose Measurement: Abbott Freestyle Libre 2 and Dexcom G7
- ClinicalTrials.gov ID
- NCT06246578
- Acronym / sponsor ID
- 791575
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Keywords
- Hypoglycemia, Continuous glucose monitoring, Dexcom, Libre, Blood glucose
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recent published work comparing different sensors has outdated our study. It is meaningless to continue to compare "old" sensors, which are updated to never version with different performance.
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 7 Feb 2024 (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 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
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Within patient comparison | Other | Device: Continuos glucose monitoring and blood glucose measurementSimultaneous glucose measurement with Libre 2 sensor and Contour Next One in patients using Dexcom G7 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Type 1 diabetes Using Dexcom G 7 -
Key exclusion criteria (2 listed)
- Do not want to participate
- -
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 |
|---|---|---|
| Continuos glucose monitoring and blood glucose measurementThe 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 | Device | Within patient comparison |
Primary outcome
Difference between paired blood glucose values and simultaneous Dexcom and Libre glucose values
Time frame: 5 minutes or less between the glucose values compared
Difference between paired blood glucose values and simultaneous CGM values for Dexcom and Libre for Dexcom values < 5 mmol/l
Difference between paired Dexcom and Libre glucose values
Time frame: 5 minutes or less between the glucose values compared
Difference between paired simultaneous CGM value for Dexcom and Libre for all measured glucose values.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: Yes. Date, time and glucose values
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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.
Klavs W Hansen, MD study director
Silkeborg Regional Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuos glucose monitoring and blood glucose measurement in people with Type 1 Diabetes and Hypoglycemia, run by Central Jutland Regional Hospital at 1 site in Denmark.
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 1 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: paused, as of the sponsor's last update on 3 Jun 2025. 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 Denmark. 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?
Results are not available in the source record.
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?
Difference between paired blood glucose values and simultaneous Dexcom and Libre glucose values (time frame: 5 minutes or less between the glucose values compared). The study lists 2 primary outcomes in all. 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 3 Jun 2025.