Assessment of Personalized Follow-up in Prevention of Type 2 Diabetes

NCT ID: NCT05325710

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-20
• Study Completion Date: 2028-04-01

Brief 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. 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.

Conditions

Diabete Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

TD2 standard

Standard TD2 follow-up

Group Type: ACTIVE_COMPARATOR

Study nurse intervention

Intervention Type: BEHAVIORAL

Contact everay 4 months with a dedicated study nurse

TD2+ study Nurse

Specific study nurse follow-up every 4 months in addition of standard FU.

Group Type: EXPERIMENTAL

Study nurse intervention

Intervention Type: BEHAVIORAL

Contact everay 4 months with a dedicated study nurse

Interventions

Study nurse intervention

Contact everay 4 months with a dedicated study nurse

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Clinical Trial Experts Network

OTHER

Sponsor Role: collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Aguiléra

Biarritz, Aquitaine, France

Site Status: RECRUITING

Countries

France

Central Contacts

JF OUDET

Role: CONTACT

jf.oudet@ecten.eu

068346567

MH BArba

Role: CONTACT

MH.Barba@ecten.eu

0664888704

Facility Contacts

Aurélie LIETAER, DR

Role: primary

Other Identifiers

2021-A00375-36

Identifier Type: -

Identifier Source: org_study_id