Personalized Follow-up Program in the Type 2 Diabetes Prevention

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Person with a FINDRISC score ≥ 10 points

Person who has given his/her express written and informed consent

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Personalized care program

    Other intervention

    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

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: With a personalized care programExperimental treatment 1 intervention
Group B: Without a personalized care programNo intervention 0 interventions

Trial outcomes

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)

Time frame
5 years

Secondary outcomes

1

Diabetes diagnostic

measuring fasting blood glucose

Time frame
at 5 years
2

The Quality of Life

WHO questionary : total score out of 100, 26 questions with 5 likert scale items

Time frame
at 5 years
3

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.

Time frame
during 5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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