Personalized Follow-up Program in the Type 2 Diabetes Prevention

NCT04907760 | Not Yet Recruiting

• 1 other identifier: 2021-A00375-36
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type2 Diabetes

Keywords

Diabetes; Metabolic Diseases; Endocrine System Diseases; Prevention

Outcome Measures

Primary Outcomes (1)

• Risk factors for type 2 diabetes in participants

  Finnish Diabetes Risk Score (FINDRISC score) : 8 items with a total score from 0 to 26 points with 0 (no risk factor) and 26 (highest risk factor)

  5 years

Secondary Outcomes (3)

• Diabetes diagnostic

  at 5 years

• The Quality of Life

  at 5 years

• program compliance

  during 5 years

Study Arms (2)

With a personalized care program

EXPERIMENTAL

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

Other: Personalized care program

Without a personalized care program

NO INTERVENTION

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

Interventions

Personalized care program 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

With a personalized care program

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Person already diagnosed with a type 2 diabetes

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

MeSH Terms

Conditions

Diabetes Mellitus; Metabolic Diseases; Endocrine System Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Nutritional and Metabolic Diseases

Study Officials

• Aurelie LIETAER, MD

  Clinique Aguilera-RGDS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurelie LIETAER, MD

CONTACT

33 (0)5 59 57 75 60; a.lietaer@yahoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, prospective, randomized, controlled, two arms, multicentric study

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 1, 2021
• Study Start: October 10, 2021
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share