Diabete Type 2ProxipartNCT05325710
Assessment of Personalized Follow-up in Prevention of Type 2 Diabetes
A study testing Study nurse intervention in people with Diabete Type 2, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
In France, the overall prevalence of diabetes was estimated at 5% of population in 2016, type 2 diabetes (T2DM) corresponding to 90% of cases. However, this figure is greatly underestimated,since it does not take into account people who are untreated or not diagnosed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- Study nurse intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2022to 1 Apr 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, male or female, over the age of 18
- Patient with a FINDRISC score ≥10 points
- Beneficiary of a French health insurance system
- Patient having been informed and having given their consent free, enlightened and written
Who cannot join
- Patient over 75 years old
- Patient already diagnosed with type 2 diabetes
- Patient whose physical and/or psychological health is severely impaired, which according to the investigator may affect the compliance of the study participant.
- Patient participating in another research
- Patient in period of exclusion from another research always in progress at the time of inclusion.
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by court order or administration.
- Pregnant, breastfeeding or parturient women.
- Patient hospitalized without consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Aguiléra
Biarritz, Aquitaine, 64200
Aurélie LIETAER, DR
About this study
In France, the overall prevalence of diabetes was estimated at 5% of population in 2016, type 2 diabetes (T2DM) corresponding to 90% of cases. However, this figure is greatly underestimated,since it does not take into account people who are untreated or not diagnosed. However,it is estimated that 20 to 30% of adults with diabetes do not are not diagnosed. Conclusions presented during the annual meeting of the european Association for the Study of diabetes (EASD-Berlin) from 2019 suggest that signs precursors of the disease would be present up to 20 years before the diagnosis.
The Diagnosis is usually made around 40-50 years. The main factor of risk of T2D is the lifestyle, in particular a diet too rich for a too sedentary daily life.
Read more
From a medico-economic point of view, chronic pathologies (including diabetes) account for 60% of insurance expenditure illness even though they concern 35% of insured persons, i.e. 20 million patients. The average annual repayment of a type 2 diabetic patient is 4890 euros.
This study is part of this context as the starting point a reflection on a different, coordinated management, to know a preventive rather than a curative approach.
Read the detailed description
In France, the overall prevalence of diabetes was estimated at 5% of population in 2016, type 2 diabetes (T2DM) corresponding to 90% of cases. However, this figure is greatly underestimated. since it does not take into account people who are untreated or not diagnosed. However, given the silent nature of the disease, it is estimated that 20 to 30% of adults with diabetes do not are not diagnosed. This share decreases with age, falling to 13% among 55-74 year olds. Conclusions presented during the annual meeting of the european Association for the Study of diabetes (EASD-Berlin) from 2019 suggest that signs precursors of the disease would be present up to 20 years before the diagnosis.
Type 2 diabetes, or non-insulin dependent diabetes, is a metabolic disease characterized by a chronic excess of sugar in the blood, affecting both men and women. the Diagnosis is usually made around 40-50 years. The main factor of risk of T2D is the lifestyle, in particular a diet too rich for a too sedentary daily life. The direct consequences are an increase in obesity hich is itself a major risk factor for the development of T2D. Among the risk factors, we also find hyperlipidemia, high blood pressure, high blood sugar fasting, stress, smoking, heredity, family history of diabetes, or gestational diabetes.
From a medico-economic point of view, chronic pathologies (including diabetes) account for 60% of insurance expenditure illness even though they concern 35% of insured persons, i.e. 20 million patients. The average annual repayment of a type 2 diabetic patient is 4890 euros.This study is part of this context as the starting point a reflection on a different, coordinated management, to know a preventive rather than a curative approach.
- Conditions
- Diabete Type 2
- Being tested
- Study nurse intervention
- Keywords
- diabete type 2, preventive approach
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study nurse interventionBehavioural
Contact everay 4 months with a dedicated study nurse
| Study group | Role | What they receive |
|---|---|---|
| TD2 standard | Active comparator | Standard TD2 follow-up Receives: Behavioral: Study nurse intervention |
| TD2+ study Nurse | Experimental | Specific study nurse follow-up every 4 months in addition of standard FU. Receives: Behavioral: Study nurse intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
FINDRISC score
FINDRISC is a prediction tool to identify patients at risk of developing diabetes without biological analysis.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start20 Mar 2022
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Compare a group of patient with study-nurse specific regular follow-up versus standard follow-up in France
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325710
- Sponsor's protocol ID
- 2021-A00375-36
- Acronym
- Proxipart
- Status last verified
- Mar 2022
- First submitted
- 5 Apr 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Personalized Follow-up in Prevention of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05325710
- Acronym / sponsor ID
- Proxipart / 2021-A00375-36
- Conditions
- Diabete Type 2
- Keywords
- diabete type 2, preventive approach
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 13 Apr 2022 (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.
In France, the overall prevalence of diabetes was estimated at 5% of population in 2016, type 2 diabetes (T2DM) corresponding to 90% of cases. However, this figure is greatly underestimated,since it does not take into account people who are untreated or not diagnosed. However,it is estimated that 20 to 30% of adults with diabetes do not are not diagnosed. Conclusions presented during the annual meeting of the european Association for the Study of diabetes (EASD-Berlin) from 2019 suggest that signs precursors of the disease would be present up to 20 years before the diagnosis.
The Diagnosis is usually made around 40-50 years. The main factor of risk of T2D is the lifestyle, in particular a diet too rich for a too sedentary daily life.
From a medico-economic point of view, chronic pathologies (including diabetes) account for 60% of insurance expenditure illness even though they concern 35% of insured persons, i.e. 20 million patients. The average annual repayment of a type 2 diabetic patient is 4890 euros.
This study is part of this context as the starting point a reflection on a different, coordinated management, to know a preventive rather than a curative approach.
Detailed description
In France, the overall prevalence of diabetes was estimated at 5% of population in 2016, type 2 diabetes (T2DM) corresponding to 90% of cases. However, this figure is greatly underestimated. since it does not take into account people who are untreated or not diagnosed. However, given the silent nature of the disease, it is estimated that 20 to 30% of adults with diabetes do not are not diagnosed. This share decreases with age, falling to 13% among 55-74 year olds. Conclusions presented during the annual meeting of the european Association for the Study of diabetes (EASD-Berlin) from 2019 suggest that signs precursors of the disease would be present up to 20 years before the diagnosis.
Type 2 diabetes, or non-insulin dependent diabetes, is a metabolic disease characterized by a chronic excess of sugar in the blood, affecting both men and women. the Diagnosis is usually made around 40-50 years. The main factor of risk of T2D is the lifestyle, in particular a diet too rich for a too sedentary daily life. The direct consequences are an increase in obesity hich is itself a major risk factor for the development of T2D. Among the risk factors, we also find hyperlipidemia, high blood pressure, high blood sugar fasting, stress, smoking, heredity, family history of diabetes, or gestational diabetes.
From a medico-economic point of view, chronic pathologies (including diabetes) account for 60% of insurance expenditure illness even though they concern 35% of insured persons, i.e. 20 million patients. The average annual repayment of a type 2 diabetic patient is 4890 euros.This study is part of this context as the starting point a reflection on a different, coordinated management, to know a preventive rather than a curative approach.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Compare a group of patient with study-nurse specific regular follow-up versus standard follow-up in France
| Arm | Type | Receives |
|---|---|---|
| TD2 standard | Active comparator | Behavioral: Study nurse interventionStandard TD2 follow-up |
| TD2+ study Nurse | Experimental | Behavioral: Study nurse interventionSpecific study nurse follow-up every 4 months in addition of standard FU. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient, male or female, over the age of 18
- Patient with a FINDRISC score ≥10 points
- Beneficiary of a French health insurance system
- Patient having been informed and having given their consent free, enlightened and written
Key exclusion criteria (8 listed)
- Patient over 75 years old
- Patient already diagnosed with type 2 diabetes
- Patient whose physical and/or psychological health is severely impaired, which according to the investigator may affect the compliance of the study participant.
- Patient participating in another research
- Patient in period of exclusion from another research always in progress at the time of inclusion.
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 |
|---|---|---|
| Study nurse interventionContact everay 4 months with a dedicated study nurse | Behavioural | TD2 standard, TD2+ study Nurse |
Primary outcome
FINDRISC score
Time frame: 5 years
FINDRISC is a prediction tool to identify patients at risk of developing diabetes without biological analysis.
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 13 Apr 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study nurse intervention in people with Diabete Type 2, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Apr 2022. 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 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 JF OUDET (068346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FINDRISC score (time frame: 5 years). 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 13 Apr 2022.