Assessment of Personalized Follow-up in Prevention of Type 2 Diabetes (Proxipart)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: MH BArba
- Numéro de téléphone: 0664888704
- E-mail: MH.Barba@ecten.eu
Sauvegarde des contacts de l'étude
- Nom: JF OUDET
- Numéro de téléphone: 068346567
- E-mail: jf.oudet@ecten.eu
Lieux d'étude
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Aquitaine
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Biarritz, Aquitaine, France, 64200
- Recrutement
- Clinique Aguilera
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Contact:
- Aurélie LIETAER, DR
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: TD2 standard
Standard TD2 follow-up
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Contact everay 4 months with a dedicated study nurse
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Expérimental: TD2+ study Nurse
Specific study nurse follow-up every 4 months in addition of standard FU.
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Contact everay 4 months with a dedicated study nurse
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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FINDRISC score
Délai: 5 years
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FINDRISC is a prediction tool to identify patients at risk of developing diabetes without biological analysis.
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5 years
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2021-A00375-36
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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