Diabetes MellitusGAP OUESTNCT06185491
Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living With Diabetes Using Continuous Glucose Monitoring ( GAP OUEST )
A study testing HGI in people with Diabetes Mellitus, run by Nantes University Hospital at 9 sites in France.
Trial summary
The goal of this clinical trial is to learn about the variability of HGI (Hemoglobin Glycation Index) over time in patients living with diabetes using a continuous glucose monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- HGI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 9 sitesFrance
- Study dates
- 24 Jun 2024to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major (adult subject over 18), with no upper age limit
- Enrolled in a social security scheme or beneficiary of such a scheme
- Agreement to participate (informed, written consent)
- Established diabetes (regardless the type of diabetes), known for at least 6 months at inclusion
- Regular user of a glucose monitoring system for at least 3 months.
- Non inclusion Criteria:
Show all 12Show fewer
- Known hemoglobinopathy
- Inadequate use of the flash glucose monitoring system with a capture rate of less than 70% of interstitial glucose measurements, during the 3 months preceding the inclusion visit.
- Stage 5 renal insufficiency (CKD-EPI less than 15 mL/min/1.73 m2)
- Pregnant or breast-feeding
- Major under guardianship, curatorship or safeguard of justice
- Any situation assessed by the investigator as potentially prejudicial to the participant's health as a result of participation in the study
Who cannot join
- Treatment with corticosteroids in the 3 months preceding the visit
- Unusual acute situation (infection, very unusual physical activity, etc.) deemed significant by the investigator
- Pregnancy started
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU d'Angers
Angers, 49100
CHU de Brest
Brest, 29200
CHU de Caen
Caen, 14033
CH du Mans
Le Mans, 72037
CHU de Nantes
Nantes, 44093
CHU de Poitiers
Poitiers, 86021
Hôpital NOVO
Pontoise, 95300
CHU de Rennes
Rennes, 35000
CHU de Toulouse
Toulouse, 31059
About this study
Official title: Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living With Diabetes Using Continuous Glucose Monitoring
The goal of this clinical trial is to learn about the variability of HGI (Hemoglobin Glycation Index) over time in patients living with diabetes using a continuous glucose monitoring.
- Conditions
- Diabetes Mellitus
- Being tested
- HGI
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HGIOther
Data collection from glucose monitoring systems and dosage of glycated hemoglobin and glycated albumin measured 3 times at 6-month intervals (+/- 3 months)
| Study group | Role | What they receive |
|---|---|---|
| HGI | Experimental | Data collection from glucose monitoring systems. Dosage of glycated hemoglobin and glycated albumin Receives: Other: HGI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of variation of individual HGI distribution
calculated from 3 HGI values, measured 6 months apart, HGI = HbA1C measured in laboratory - HbA1C estimated
Measured: 12 months
Secondary outcomes (2)
Coefficient of variation of the individual distribution of the albumin glycation index
Albumin glycation index = glycated albumin measured in laboratory - glycated albumine estimated
Measured: 12 months
Glycation gap, determined from comparison between HbA1C measured and HbA1C derived from glycated albumin
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start24 Jun 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène AUFFRET, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185491
- Sponsor's protocol ID
- RC22_0502
- Acronym
- GAP OUEST
- Status last verified
- May 2026
- First submitted
- 15 Dec 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living With Diabetes Using Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT06185491
- Acronym / sponsor ID
- GAP OUEST / RC22_0502
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 29 Dec 2023 (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 goal of this clinical trial is to learn about the variability of HGI (Hemoglobin Glycation Index) over time in patients living with diabetes using a continuous glucose monitoring.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HGI | Experimental | Other: HGIData collection from glucose monitoring systems. Dosage of glycated hemoglobin and glycated albumin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Major (adult subject over 18), with no upper age limit
- Enrolled in a social security scheme or beneficiary of such a scheme
- Agreement to participate (informed, written consent)
- Established diabetes (regardless the type of diabetes), known for at least 6 months at inclusion
- Regular user of a glucose monitoring system for at least 3 months.
Key exclusion criteria (3 listed)
- Treatment with corticosteroids in the 3 months preceding the visit
- Unusual acute situation (infection, very unusual physical activity, etc.) deemed significant by the investigator
- Pregnancy started
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 |
|---|---|---|
| HGIData collection from glucose monitoring systems and dosage of glycated hemoglobin and glycated albumin measured 3 times at 6-month intervals (+/- 3 months) | Other | HGI |
Primary outcome
Coefficient of variation of individual HGI distribution
Time frame: 12 months
calculated from 3 HGI values, measured 6 months apart, HGI = HbA1C measured in laboratory - HbA1C estimated
2 secondary outcomes
Coefficient of variation of the individual distribution of the albumin glycation index
Time frame: 12 months
Glycation gap, determined from comparison between HbA1C measured and HbA1C derived from glycated albumin
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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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.
Hélène AUFFRET principal investigator
Nantes University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HGI in people with Diabetes Mellitus, run by Nantes University Hospital at 9 sites in France.
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 12 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Coefficient of variation of individual HGI distribution (time frame: 12 months). 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 26 May 2026.