Personalized Follow-up Program in the Type 2 Diabetes Prevention

Study Overview
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Brief Summary
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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
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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.

Official Title
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Personalized Follow-up Program in the Type 2 Diabetes Prevention

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Other: Personalized care program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional, prospective, randomized, controlled, two arms, multicentric study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With a personalized care program<br>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<br>* 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<br>|
| No Intervention: Without a personalized care program<br>The comparison strategy does not include any specific management. The patient will not receive individualized management with the nurse coordinator. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes diagnostic | measuring fasting blood glucose | at 5 years | 
| The Quality of Life | WHO questionary : total score out of 100, 26 questions with 5 likert scale items | at 5 years | 
| program compliance | Compliance is based on all the scheduled visits, the number of visits not carried out and the time during the research will be described in each group. | during 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Diseases, Prevention, Diabetes, Endocrine System Diseases