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.

Study Overview

• Status: Recruiting
• Conditions: Diabete Type 2
• Intervention / Treatment: Behavioral: Study nurse intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MH BArba; Phone Number: 0664888704; Email: MH.Barba@ecten.eu
• Study Contact Backup: Name: JF OUDET; Phone Number: 068346567; Email: jf.oudet@ecten.eu

Study Locations

• France
  • Aquitaine
    • Biarritz, Aquitaine, France, 64200
      • Recruiting
      • Clinique Aguiléra
      • Contact: Aurélie LIETAER, DR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TD2 standard; Standard TD2 follow-up	Behavioral: Study nurse intervention; Contact everay 4 months with a dedicated study nurse
Experimental: TD2+ study Nurse; Specific study nurse follow-up every 4 months in addition of standard FU.	Behavioral: Study nurse intervention; Contact everay 4 months with a dedicated study nurse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FINDRISC score	FINDRISC is a prediction tool to identify patients at risk of developing diabetes without biological analysis.	5 years

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: European Clinical Trial Experts Network

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2022
• Primary Completion (Anticipated): April 1, 2028
• Study Completion (Anticipated): April 1, 2028

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: diabete type 2; preventive approach
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2021-A00375-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No