Personalized Follow-up Program in the Type 2 Diabetes Prevention

NCT ID: NCT04907760

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-10
• Study Completion Date: 2026-10-10

Brief Summary

In France, the global prevalence of diabetes was estimated to 5% of the population in 2016, the type two diabetes (DT2) corresponding to 90% of cases. This number is widely underestimated because most people are untreated and undiagnosed. Due to the silent character of this disease, it is estimated that 20 à 30 % of diabetic adults have not yet been diagnosed. The conclusions, presented during the annual meeting of EASD in 2019, suggest that the precursor signs of this disease could be present until 20 years before the diagnosis.

Diabetes is a metabolic disease and people are diagnosed, in general, around 40-50 years old. The main risk factor of type II diabetes is lifestyle (rich diet, sedentary) but there is also other factors like hyperlipidemia, high blood pressure, high fasting blood sugar, stress, smoking, heredity, family history of diabetes, or gestational diabetes. This induces an increase of obesity, itself a major risk factor for type II diabetes occurrence.

From an economical aspect, chronic pathologies (including diabetes) represent 60% of health insurance expenses, even though it concerns 35% of insured persons, i.e. 20 million of patients. The average of annual reimbursement for a type 2 diabetic patient is 4890 euros. In this context, this study is the first step of thinking about a different, coordinated care approach, based on a preventive rather than curative approach.

Detailed Description

This study includes a personalized care program, including the patient follow-up by a nurse during 5 years with a contact every 4 months for the first year, then after every 6 months. The nurse will review the patient's progress and provide advice and contact with professionals: physical activity, psychologists, dieticians, endocrinologists, etc The main objective of this study is to compare, after 5 years of follow-up, the risk factors associated with type 2 diabetes, between participants who received personalized follow-up and those who did not. The secondary objectives are to compare the occurrence of type 2 diabetes, the quality of life and the compliance to the program between participants who received personalized follow-up and those who did not.

Conditions

Type2 Diabetes

Study Design

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

Study Groups

With a personalized care program

The strategy implemented is a personalized care pathway that includes participant follow-up by a nurse for 5 years with contact every 4 months for the first year, then every 6 months

Group Type: EXPERIMENTAL

Personalized care program

Intervention Type: OTHER

It includes the participant follow-up by a nurse during 5 years with a contact every 4 months for the first year, then after every 6 months

Without a personalized care program

The comparison strategy does not include any specific management. The patient will not receive individualized management with the nurse coordinator.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Personalized care program

It includes the participant follow-up by a nurse during 5 years with a contact every 4 months for the first year, then after every 6 months

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Person with a FINDRISC score ≥ 10 points
• Person who has given his/her express written and informed consent

Exclusion Criteria

• Person already diagnosed with a type 2 diabetes

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurelie LIETAER, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Aguilera-RGDS

Central Contacts

Aurelie LIETAER, MD

Role: CONTACT

a.lietaer@yahoo.fr

33 (0)5 59 57 75 60

Other Identifiers

2021-A00375-36

Identifier Type: -

Identifier Source: org_study_id