Periodontal DiseaseGlyCoSupNCT07165171
Periodontal Follow-up and Glycemy in Patients With Type 2 Diabetes
A study testing Innovative periodontal monitoring (SuP innovative) in people with Periodontal Disease, run by Hospices Civils de Lyon at 8 sites in France.
Trial summary
Diabetes is a disease in which the majority of these patients have type 2 diabetes, linked to poor use of insulin by the body. Periodontitis is a chronic disease characterized by an immuno-inflammatory reaction with local production of inflammatory mediators (IL6, TNF-alpha, etc.) and contributes to the increase in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- Innovative periodontal monitoring (SuP innovative)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 8 sitesFrance
- Study dates
- 1 Oct 2025to 1 Oct 2030
- 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
- -- Adult aged 18 years or older;
- Presenting with type 2 diabetes (under ALD), balanced or not, for 6 months or more;
- Having been treated in the previous 6 months for periodontitis (stages 1 to 4 according to the new classification of periodontal and peri-implant diseases EFP-AAP 2018) in one of the participating centers and presenting a clinical situation allowing the transition to the periodontal follow-up phase (; (absence or limited number of sites presenting clinical signs of persistent periodontal inflammation)
- Presenting more than 6 teeth;
- Possessing a smartphone or tablet with internet access;
- Affiliated to social security;
- Patient able to read, write and understand French
- Having signed a consent to participate in the study.
Who cannot join
- Patient presenting uncontrolled systemic diseases and diagnosed for less than 6 months or presenting a major aggravation of a systemic pathology according to the judgment of the investigator.
- Pregnant or breastfeeding women;
- Persons deprived of liberty by a judicial or administrative decision;
- Adults subject to a legal protection measure (guardianship, curatorship).
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites
Hôpital Charles Foix
Ivry-sur-Seine, 94200
Marjolaine GOSSET, Pr, 1 49 59 48 03 ext. +33, marjolaine.gosset@aphp.fr
Marjolaine GOSSET, Pr
Centre Hospitalo-Universitaire de Lille
Lille, 59000
Kevimy AGOSSA, Pr, 3 20 44 43 55 ext. +33, kevimy.agossa@univ-lille.fr
Kevimy AGOSSA, Pr
Hospices Civils de Lyon, Centre de Soins Dentaires.
Lyon, 69007
Brigitte GROSGOGEAT, Professor, 0662162525 ext. +33, brigitte.grosgogeat@chu-lyon.fr
Brigitte GROSGOGEAT, Pr
Centre Hospitalo-Universitaire de Nantes
Nantes, 44000
Xavier STRUILLOU, MD, 6 61 37 46 16 ext. +33
Xavier STRUILLOU, MD
Centre Hospitalo-Universitaire de Rennes
Rennes, 35000
Helene Rangé, Pr, 02 99 28 24 00, helene.range@chu-rennes.fr
Helene RANGE, Pr
Cabinet libéral
Saint-Victor-de-Cessieu, 38110
Marie BARRAS, MD, 4 74 90 35 19 ext. +33, drbarras.marie@gmail.com
Marie BARRAS, MD
Hôpitaux universitaires de Strasbourg
Strasbourg, 67000
Olivier HUCK, Pr, 3 88 11 69 47 ext. +33, o.huck@unistra.fr
Olivier HUCK, MD
Centre Hospitalo-Universitaire de Toulouse
Toulouse, 31300
Sara LAURENCIN, DM, 6 80 43 87 15 ext. +33, sara.laurencin-dalicieux@univ-tlse3.fr
Sara LAURENCIN, MD
About this study
Official title: Glycemy After Periodontal Treatment in Patients With Type 2 Diabetes: a Randomized Controlled Trial Comparing Innovative Versus Standard Periodontal Follow-up
Diabetes is a disease in which the majority of these patients have type 2 diabetes, linked to poor use of insulin by the body.
Periodontitis is a chronic disease characterized by an immuno-inflammatory reaction with local production of inflammatory mediators (IL6, TNF-alpha, etc.) and contributes to the increase in the systemic inflammatory load with increased levels of C-reactive protein.
Read more
Periodontitis is frequently found in diabetic patients; it is considered a complication of diabetes. Poor glycemic control in diabetes is associated with poor periodontal health, while periodontal infection is associated with dysglycemia and increased insulin resistance.
Periodontal treatment has been shown to reduce HbA1C levels and thus the risk of complications in diabetic patients.
The main objective is to evaluate the impact of innovative periodontal monitoring (with reminder systems and reinforcement of advice by SMS) versus standard periodontal monitoring on the glycemic control of diabetic patients treated for periodontitis, 2 years after the start of periodontal monitoring.
Read the detailed description
Diabetes is a disease in which the majority of these patients have type 2 diabetes, linked to poor use of insulin by the body.
Periodontitis is a chronic disease characterized by an immuno-inflammatory reaction with local production of inflammatory mediators (IL6, TNF-alpha, etc.) and contributes to the increase in the systemic inflammatory load with increased levels of C-reactive protein.
Periodontitis is frequently found in diabetic patients; it is considered a complication of diabetes. Poor glycemic control in diabetes is associated with poor periodontal health, while periodontal infection is associated with dysglycemia and increased insulin resistance.
Periodontal treatment has been shown to reduce HbA1C levels and thus the risk of complications in diabetic patients.
However, periodontitis is a recurring disease; The implementation of periodontal monitoring (SuP) is essential throughout life after periodontal treatment, in order to prevent relapses. This monitoring, which must be carried out for life, includes the reassessment of periodontal criteria, professional instrumentation and oral hygiene (HBD) advice.
Visits every 3 months are generally recommended at the beginning, in order to regularly reinforce HBD advice. However, adherence to the SuP is difficult to obtain in the long term. In orthodontic patients, the use of reminder systems (SMS, emails, mobile applications, etc.) has a positive effect on HBD and periodontal criteria and would improve the rate of attendance at appointments in the medium term (3-12 months). A reminder and reinforcement system for HBD advice could therefore be integrated into the SuP in order to improve HBD and longer-term adherence in diabetic patients.
The main objective is to evaluate the impact of innovative periodontal monitoring (with reminder systems and reinforcement of advice by SMS) versus standard periodontal monitoring on the glycemic control of diabetic patients treated for periodontitis, 2 years after the start of periodontal monitoring.
This is a comparative experimental study to evaluate the effectiveness of a new monitoring strategy for type 2 diabetic patients who have been treated for periodontitis, a randomized controlled trial including an implementation study using a mixed methods approach (quantitative and qualitative).
The research will take place in 7 hospitals (Lille, Lyon, Nantes, Paris, Rennes, Strasbourg, Toulouse) and 7 privates dental centers in France.
Two types of care are proposed after periodontal treatment (all patients included will have previously benefited from standard periodontal treatment in the different centers).
The two groups compared will be:
- For the Experimental Group: Innovative periodontal monitoring.
- For the Control Group: Standard periodontal follow-up.
The primary endpoint is the HbA1c level (expressed in %) at 2 years after the date of randomization. The HbA1c level at 2 years will be collected by performing a routine dosage, in the patient's usual laboratory.
The target population of the GlyCoSuP project concerns adults with type 2 diabetes who have been treated for periodontitis.
After increasing by 10% to take into account those lost to follow-up, the total number of patients to be included will be 516 (258 patients per arm).
The duration of the inclusion period will be 24 months and the participation for each subject will be 24 months. In total, the total duration of the study will be 48 months.
- Conditions
- Periodontal Disease
- Being tested
- Innovative periodontal monitoring (SuP innovative)
- Keywords
- periodontal disease, Glycemy, Diabetes type 2, Follow-up
- Medical subject headings
- Periodontal Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovative periodontal monitoring (SuP innovative)Procedure or surgery
Also called Innovative periodontal monitoring (SuP innovative
Different types of SMS messages will be sent alternately.
- Type 1 SMS: SMS providing targeted medical information specifically for diabetic patients.
- Type 2 SMS: Interactive SMS text messages written in the form of questions.
- Type 3 SMS: Before each scheduled periodontal follow-up visit (every 3 months), a reminder SMS will be sent with the date, time, and location of the appointment.
The SMS messages are intended for patients in the experimental group. Over these 24 months, the following are planned per patient:
- 1 Type 1 SMS/week (medical advice or information);
- 1 Type 2 SMS/month (interactive with suggested answers);
- 1 Type 3 SMS every 3 months (appointment reminder): 1 per visit. The various text messages will be scheduled from the beginning of the periodontal follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: SuP innovant (sending Short Message Service - SMS) | Experimental | For the Experimental Group: Innovative periodontal monitoring (SuP), consisting of:
* visits every 3 months during 24 months with reinforcement of HBD advice and professional instrumentation - supra- and subgingival debridement if necessary. (common to the control group)
* sending of different types of SMS: different types of SMS messages will be sent alternately.
The SMS messages are intended for patients in the experimental group. The proposed approach aims to maintain contact with the patient at home and strengthen their commitment to a good oral hygiene routine over the long term. Text messages will be sent via the French CURECALL platform.
The various text messages will be scheduled from the beginning of the periodontal follow-up. Receives: Procedure: Innovative periodontal monitoring (SuP innovative) |
| Control group: SuP standard | No intervention | For the Control Group: Standard periodontal follow-up (SuP), consisting of: visits every 3 months with reinforcement of HBD advice and professional instrumentation - supra- and subgingival debridement if necessary (common to the experimental group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c level (expressed as a %)
The HbA1c level will be collected by routine testing in the patient's usual laboratory.
This endpoint will be collected without knowing the patient's group. To limit missing data, a letter will be sent to the healthcare professional responsible for the patient's diabetes management (of the two groups) at the time of inclusion. If necessary, their physician may be contacted to retrieve this data, with the patient's consent.
During the previous visit, the patient will be reminded to bring their test results for the next visit. This will also be noted in the appointment reminder text message.
Measured: At 2 years after the date of randomization.
Secondary outcomes (7)
Periodontal criteria: - average probing depth (mm),
The periodontal probe used will be identical for all centers (purchase included in the study-funded budget): a manual periodontal probe with constant pressure, thus reinforcing standardization of practices.
Collected by the investigator at inclusion and then every 3 months up to 24 months post-randomization.
Measured: At inclusion and then every 3 months up to 24 months post-randomization.
Periodontal criteria: - bleeding index on probing (%),
The periodontal probe used will be identical for all centers (purchase included in the study-funded budget): a manual periodontal probe with constant pressure, thus reinforcing standardization of practices.
Measured: At inclusion then every 3 months until up to 24 months post-randomization.
Periodontal criteria: - average clinical attachment level (mm),
The periodontal probe used will be identical for all centers (purchase included in the study-funded budget): a manual periodontal probe with constant pressure, thus reinforcing standardization of practices.
Measured: At inclusion and then every 3 months up to 24 months post-randomization.
Periodontal criteria: - number of sites with a probing depth strictly greater than or equal to 4 mm (but with bleeding on probing),
The periodontal probe used will be identical for all centers (purchase included in the study-funded budget): a manual periodontal probe with constant pressure, thus reinforcing standardization of practices.
Measured: at inclusion and then every 3 months up to 24 months post-randomization.
Periodontal criteria: - number of tooth loss,
The periodontal probe used will be identical for all centers (purchase included in the study-funded budget): a manual periodontal probe with constant pressure, thus reinforcing standardization of practices.
Measured: at inclusion and then every 3 months up to 24 months post-randomization.
Periodontal criteria: - number of sites re-instrumented by debridement/root planing
The periodontal probe used will be identical for all centers (purchase included in the study-funded budget): a manual periodontal probe with constant pressure, thus reinforcing standardization of practices.
Measured: at inclusion and then every 3 months up to 24 months post-randomization.
Diabetic Pathology Criteria: - HbA1c level (%),
HbA1c level (%): data collected from routine laboratory tests performed as part of diabetes management, in accordance with the recommendations of the French National Authority for Health (HAS), As a last resort, the physician may be contacted with the patient's consent to ensure that there have been no changes to the prescription since the last visit.
Measured: At inclusion then every 3 months until 24 months post-randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental comparative study to evaluate the effectiveness of a new strategy for monitoring type 2 diabetic patients who have been treated for periodontitis: \- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 516 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165171
- Sponsor's protocol ID
- 69HCL23_0377
- Other IDs
- 2024-A01407-40
- Acronym
- GlyCoSup
- Status last verified
- Sep 2025
- First submitted
- 13 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemy After Periodontal Treatment in Patients With Type 2 Diabetes: a Randomized Controlled Trial Comparing Innovative Versus Standard Periodontal Follow-up
- ClinicalTrials.gov ID
- NCT07165171
- Acronym / sponsor ID
- GlyCoSup / 69HCL23_0377
- Conditions
- Periodontal Disease
- Keywords
- periodontal disease, Glycemy, Diabetes type 2, Follow-up
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 516 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 10 Sep 2025 (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.
Diabetes is a disease in which the majority of these patients have type 2 diabetes, linked to poor use of insulin by the body.
Periodontitis is a chronic disease characterized by an immuno-inflammatory reaction with local production of inflammatory mediators (IL6, TNF-alpha, etc.) and contributes to the increase in the systemic inflammatory load with increased levels of C-reactive protein.
Periodontitis is frequently found in diabetic patients; it is considered a complication of diabetes. Poor glycemic control in diabetes is associated with poor periodontal health, while periodontal infection is associated with dysglycemia and increased insulin resistance.
Periodontal treatment has been shown to reduce HbA1C levels and thus the risk of complications in diabetic patients.
The main objective is to evaluate the impact of innovative periodontal monitoring (with reminder systems and reinforcement of advice by SMS) versus standard periodontal monitoring on the glycemic control of diabetic patients treated for periodontitis, 2 years after the start of periodontal monitoring.
Detailed description
Diabetes is a disease in which the majority of these patients have type 2 diabetes, linked to poor use of insulin by the body.
Periodontitis is a chronic disease characterized by an immuno-inflammatory reaction with local production of inflammatory mediators (IL6, TNF-alpha, etc.) and contributes to the increase in the systemic inflammatory load with increased levels of C-reactive protein.
Periodontitis is frequently found in diabetic patients; it is considered a complication of diabetes. Poor glycemic control in diabetes is associated with poor periodontal health, while periodontal infection is associated with dysglycemia and increased insulin resistance.
Periodontal treatment has been shown to reduce HbA1C levels and thus the risk of complications in diabetic patients.
However, periodontitis is a recurring disease; The implementation of periodontal monitoring (SuP) is essential throughout life after periodontal treatment, in order to prevent relapses. This monitoring, which must be carried out for life, includes the reassessment of periodontal criteria, professional instrumentation and oral hygiene (HBD) advice.
Visits every 3 months are generally recommended at the beginning, in order to regularly reinforce HBD advice. However, adherence to the SuP is difficult to obtain in the long term. In orthodontic patients, the use of reminder systems (SMS, emails, mobile applications, etc.) has a positive effect on HBD and periodontal criteria and would improve the rate of attendance at appointments in the medium term (3-12 months). A reminder and reinforcement system for HBD advice could therefore be integrated into the SuP in order to improve HBD and longer-term adherence in diabetic patients.
The main objective is to evaluate the impact of innovative periodontal monitoring (with reminder systems and reinforcement of advice by SMS) versus standard periodontal monitoring on the glycemic control of diabetic patients treated for periodontitis, 2 years after the start of periodontal monitoring.
This is a comparative experimental study to evaluate the effectiveness of a new monitoring strategy for type 2 diabetic patients who have been treated for periodontitis, a randomized controlled trial including an implementation study using a mixed methods approach (quantitative and qualitative).
The research will take place in 7 hospitals (Lille, Lyon, Nantes, Paris, Rennes, Strasbourg, Toulouse) and 7 privates dental centers in France.
Two types of care are proposed after periodontal treatment (all patients included will have previously benefited from standard periodontal treatment in the different centers).
The two groups compared will be:
- For the Experimental Group: Innovative periodontal monitoring.
- For the Control Group: Standard periodontal follow-up.
The primary endpoint is the HbA1c level (expressed in %) at 2 years after the date of randomization. The HbA1c level at 2 years will be collected by performing a routine dosage, in the patient's usual laboratory.
The target population of the GlyCoSuP project concerns adults with type 2 diabetes who have been treated for periodontitis.
After increasing by 10% to take into account those lost to follow-up, the total number of patients to be included will be 516 (258 patients per arm).
The duration of the inclusion period will be 24 months and the participation for each subject will be 24 months. In total, the total duration of the study will be 48 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental comparative study to evaluate the effectiveness of a new strategy for monitoring type 2 diabetic patients who have been treated for periodontitis: - randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group: SuP innovant (sending Short Message Service - SMS) | Experimental | Procedure: Innovative periodontal monitoring (SuP innovative)For the Experimental Group: Innovative periodontal monitoring (SuP), consisting of: * visits every 3 months during 24 months with reinforcement of HBD advice and professional instrumentation - supra- and subgingival debridement if necessary. (common to the control group) * sending of different types of SMS: different types of SMS messages will be sent alternately. The SMS messages are intended for patients in the experimental group. The proposed approach aims to maintain contact with the patient at home and strengthen their commitment to a good oral hygiene routine over the long term. Text messages will be sent via the French CURECALL platform. The various text messages will be scheduled from the beginning of the periodontal follow-up. |
| Control group: SuP standard | No intervention | –For the Control Group: Standard periodontal follow-up (SuP), consisting of: visits every 3 months with reinforcement of HBD advice and professional instrumentation - supra- and subgingival debridement if necessary (common to the experimental group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- -- Adult aged 18 years or older;
- Presenting with type 2 diabetes (under ALD), balanced or not, for 6 months or more;
- Having been treated in the previous 6 months for periodontitis (stages 1 to 4 according to the new classification of periodontal and peri-implant diseases EFP-AAP 2018) in one of the participating centers and presenting a clinical situation allowing the transition to the periodontal follow-up phase (; (absence or limited number of sites presenting clinical signs of persistent periodontal inflammation)
- Presenting more than 6 teeth;
- Possessing a smartphone or tablet with internet access;
Key exclusion criteria (4 listed)
- Patient presenting uncontrolled systemic diseases and diagnosed for less than 6 months or presenting a major aggravation of a systemic pathology according to the judgment of the investigator.
- Pregnant or breastfeeding women;
- Persons deprived of liberty by a judicial or administrative decision;
- Adults subject to a legal protection measure (guardianship, curatorship).
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 |
|---|---|---|
| Innovative periodontal monitoring (SuP innovative)Also: Innovative periodontal monitoring (SuP innovativeDifferent types of SMS messages will be sent alternately. * Type 1 SMS: SMS providing targeted medical information specifically for diabetic patients. * Type 2 SMS: Interactive SMS text messages written in the form of questions. * Type 3 SMS: Before each scheduled periodontal follow-up visit (every 3 months), a reminder SMS will be sent with the date, time, and location of the appointment. The SMS messages are intended for patients in the experimental group. Over these 24 months, the following are planned per patient: * 1 Type 1 SMS/week (medical advice or information); * 1 Type 2 SMS/month (interactive with suggested answers); * 1 Type 3 SMS every 3 months (appointment reminder): 1 per visit. The various text messages will be scheduled from the beginning of the periodontal follow-up. | Procedure or surgery | Intervention group: SuP innovant (sending Short Message Service - SMS) |
Primary outcome
HbA1c level (expressed as a %)
Time frame: At 2 years after the date of randomization.
The HbA1c level will be collected by routine testing in the patient's usual laboratory. This endpoint will be collected without knowing the patient's group. To limit missing data, a letter will be sent to the healthcare professional responsible for the patient's diabetes management (of the two groups) at the time of inclusion. If necessary, their physician may be contacted to retrieve this data, with the patient's consent. During the previous visit, the patient will be reminded to bring their test results for the next visit. This will also be noted in the appointment reminder text message.
7 secondary outcomes
Periodontal criteria: - average probing depth (mm),
Time frame: At inclusion and then every 3 months up to 24 months post-randomization.
Periodontal criteria: - bleeding index on probing (%),
Time frame: At inclusion then every 3 months until up to 24 months post-randomization.
Periodontal criteria: - average clinical attachment level (mm),
Time frame: At inclusion and then every 3 months up to 24 months post-randomization.
Periodontal criteria: - number of sites with a probing depth strictly greater than or equal to 4 mm (but with bleeding on probing),
Time frame: at inclusion and then every 3 months up to 24 months post-randomization.
Periodontal criteria: - number of tooth loss,
Time frame: at inclusion and then every 3 months up to 24 months post-randomization.
Periodontal criteria: - number of sites re-instrumented by debridement/root planing
Time frame: at inclusion and then every 3 months up to 24 months post-randomization.
Diabetic Pathology Criteria: - HbA1c level (%),
Time frame: At inclusion then every 3 months until 24 months post-randomization.
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 10 Sep 2025.
- Individual participant dataSharing planned: No
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innovative periodontal monitoring (SuP innovative) in people with Periodontal Disease, run by Hospices Civils de Lyon at 8 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 8 inclusion and 4 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: opening soon, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Contact Kerstin GRITSCH, Prefessor (4 27 85 40 30 ext. +33, kerstin.gritsch@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c level (expressed as a %) (time frame: At 2 years after the date of randomization.). 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 10 Sep 2025.