Methodology for the Entred-Ado component

Objectives of Entred-Ado

In 2007, the French National Institute of Health and Medical Research (Inserm) conducted an assessment of current knowledge and needs in the epidemiology of childhood diabetes at the request of the French Institute for Public Health Surveillance. The report particularly emphasized the need for epidemiological surveys to better understand the health status and healthcare utilization patterns of children with diabetes, as well as the impact of diabetes on the lives of children and their families. Adolescence is specifically described in this report as a critical period, as it can lead to a departure from the recommended disease management system.

Entred-Ado is a study that complements the 2007–2010 Entred study and aims to provide epidemiological data on adolescents with diabetes living in France. The specific objectives of the Entred-Ado study are:

1/ to describe the health status of adolescents with diabetes aged 11 to 17 as of August 1, 2007, as well as their treatment, care, and healthcare journey;

2/ to analyze the quality of life of adolescents with diabetes and their integration in school, extracurricular, family, and social settings;

3/ to evaluate the adequacy of care in light of the recommendations of the Haute Autorité de Santé (HAS).

Participants selected for Entred-Ado

Sending of an informational letter by the Health Insurance

For Entred-Ado, approximately 600 adolescents were selected by random drawing from among all individuals:

  • aged 11 to 17 as of August 1, 2007;

  • residing in mainland France or overseas territories;

  • insured by or beneficiaries of the National Health Insurance Fund for Salaried Workers (CnamTS) or the Social Security System for the Self-Employed (RSI);

  • who had received at least three reimbursements for oral antidiabetic medications and/or insulin over the past 12 months.

A random anonymization number was assigned to each person.

  • explain the purpose of the Entred-Ado study;

  • ask the adolescents (or young adults) and their parents for their consent to participate in the study, and for their consent to share their contact information as well as that of their doctors with the National Institute of Health and Medical Research (Inserm).

A toll-free number (0 805 40 02 10) allows affected families to obtain additional information

A “healthcare utilization” survey

Anonymous data on reimbursements for medications, medical procedures (consultations, laboratory tests), medical supplies, and hospitalizations for adolescents with diabetes are extracted from the files of the Health Insurance system and the Medical Information Systems Program (PMSI) over a 3-year period.

A telephone survey conducted by Inserm

The contact information of the selected individuals who have given their consent (as well as that of their doctors) is forwarded to the French National Institute of Health and Medical Research (Inserm). Inserm continues the study with a telephone interview with adolescents with diabetes and their parents, lasting approximately 40 minutes.

A mail survey of the treating physicians of adolescents with diabetes

A supplementary survey is conducted by mail among the physicians of adolescents with diabetes who have agreed to provide the National Institute of Health and Medical Research (Inserm) with the contact information of the physicians managing their diabetes. A questionnaire accompanied by an informational letter is sent to the physicians to obtain additional medical information essential for the epidemiological surveillance of diabetes.

A toll-free number (0 805 40 02 10) allows the contacted physicians to obtain additional information about the study.

A telephone survey of “control” adolescents

The Entred-Ado survey focuses in particular on how adolescents with diabetes fit into their social environment, in order to determine the impact of the disease on their daily lives. This requires a comparison with the general population: each adolescent with diabetes interviewed receives an information sheet and a consent form to distribute to 8 of their classmates or friends of the same age (if not in school). The information sheet describes the study’s objectives, the importance of establishing a “control” group, and the survey method (the same toll-free number, 0805 40 02 10, is provided to them). Adolescents who agreed to participate in the survey are contacted by phone to answer the same questionnaire as the adolescents with diabetes, excluding the questions specific to diabetes.

Data Confidentiality

The Entred-Ado study has been authorized (No. 908017) by the French Data Protection Authority (CNIL). All data collected are confidential and protected by medical confidentiality and statistical confidentiality.

The first and last names and addresses used in the survey mailings are drawn from the Health Insurance files for each selected adolescent with diabetes. These contact details are essential for establishing contact with adolescents with diabetes and their parents; they are known only to the Health Insurance services and are transmitted to the National Institute of Health and Medical Research (Inserm) only after the families’ consent.

Once collected, Entred-Ado data is anonymized before analysis, meaning it is linked to a random number without a last name, first name, or address. Under no circumstances can a doctor access the data provided by their patient, or vice versa.

Whether or not the people with diabetes who are asked choose to participate in Entred-Ado will in no way influence the care they receive.

Documents related to the Entred-Ado study: letters and questionnaires

  • Letter sent by the Health Insurance to adolescents with diabetes;

  • Consent form for participation in the study for adolescents with diabetes and their parents;

  • Questionnaire administered by phone by Inserm researchers to adolescents with diabetes;

  • Letter sent by Inserm to the physicians of adolescents with diabetes;

  • Questionnaire administered by phone by Inserm researchers to the doctors of adolescents with diabetes;

  • Information sheet for the classmates/peers of adolescents with diabetes;

  • Consent form for participation in the study for classmates/peers of adolescents with diabetes;

  • Questionnaire administered by telephone by Inserm investigators to classmates/peers of adolescents with diabetes.

Entred-Ado Scientific Committee

The members of the Entred-Ado Scientific Committee are:

  • BERTRAND Anne-Marie - Pediatrician/Endocrinologist, Besançon University Hospital

  • CAHANE Michel - Pediatrician/Diabetologist, Institut Mutualiste Montsouris, Paris; Executive Director of the Association for Assistance to Young Diabetics (AJD)

  • CHARLES Marie-Aline – Endocrinologist/Epidemiologist, Department of Public Health Research, Inserm, Villejuif

  • CROSNIER Hélène – Pediatrician/Endocrinologist, Interregional Hospital Center, Poissy/St-Germain-en-Laye

  • DE BEAUFORT Carine – Pediatrician/Endocrinologist, Clinical Unit for Pediatric Diabetes Care at the Luxembourg Hospital

  • FAGOT-CAMPAGNA Anne – Endocrinologist/Epidemiologist, French Institute for Public Health Surveillance, Diabetes Surveillance Program, Saint-Maurice

  • FONTBONNE Annick - Physician/Epidemiologist, French National Research Institute for Sustainable Development (IRD), Montpellier

  • LABEGUERIE Marylène – Project Manager, Entred-Ado, Inserm, Paris

  • LAISNEY Norbert – Pediatrician/Diabetologist, Basse-Normandie General Hospital

  • LE TALLEC Claire - Pediatrician/Diabetologist, Toulouse University Hospital

  • LEVY-MARCHAL Claire - Pediatrician/Endocrinologist, Robert Debré University Hospital, Paris; Inserm, Paris

  • MALIVOIR Sabine – Psychologist, Robert Debré University Hospital, Paris

  • ROBERT Jean-Jacques – Pediatrician/Diabetologist, Necker Enfants Malades University Hospital, Paris; President of the Association for Assistance to Young Diabetics (AJD)

  • ROMON Isabelle – Research Coordinator, French Institute for Public Health Surveillance, Diabetes Surveillance Program, Saint-Maurice

  • STUCKENS Chantal – Pediatrician/Diabetologist, University Hospital, Lille

  • TUBIANA-RUFI Nadia - Pediatrician/Endocrinologist, Robert Debré University Hospital, Paris

  • VEXIAU Patrick – Endocrinologist – Saint Louis University Hospital, Paris; Secretary General of the French Diabetes Association (AFD)

Funding Partners

The funding partners of Entred-Ado are:

- The French Institute for Public Health Surveillance (InVS)

- The French National Institute of Health and Medical Research (Inserm)

- The Directorate General for Health (DGS)

- The French Diabetes Association (AFD)

- Aid for Young People with Diabetes (AJD)

Contacts

ENTRED-Ado 2007

National Institute of Health and Medical Research (Inserm) – U690

Robert-Debré Hospital

48, Boulevard Sérurier

75019 Paris

For further information about Entred-Ado, please call: 0 805 40 02 10 (toll-free number).

A fax number is also available: 01 40 40 91 95.