EDITH - Observational study to evaluate educational modality of type 2 diabetic patients at the time of insulin initiation by GPs 
Head :
Vignal Franck, Sanofi Aventis
Last update : 01/01/2018 | Version : 1 | ID : 84
| General | |
| Identification | |
| Detailed name | Observational study to evaluate educational modality of type 2 diabetic patients at the time of insulin initiation by GPs |
| Sign or acronym | EDITH |
| General Aspects | |
| Medical area |
Endocrinology and metabolism General practice |
| Others (details) | type-2 diabetes |
| Keywords | initiation of insulin therapy, insulin |
| Scientific investigator(s) (Contact) | |
| Name of the director | Vignal |
| Surname | Franck |
| Phone | +33 (0)1 57 63 26 47 |
| franck.vignal@sanofi-aventis.com | |
| Unit | Sanofi Aventis |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Sanofi-aventis |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Sanofi-aventis France |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | participating general practitioners systematically included the last two consecutive patients that they had put on insulin since less than 6 months and more than 1 month, who met the inclusion criteria and accepted to participate in the study. |
| Database objective | |
| Main objective | describe the effects on the fasting glucose at 1 month for main methods of education of type-2 diabetes patients during the initiation of insulin therapy in general practice |
| Inclusion criteria | man or woman, over the age of 18 years, having a type-2 diabetes responding to the criteria of HAS (French National Authority for Health), treated with oral diabetes medication at the maximum dose (or maximum tolerated dose where applicable), having needed the adding of a basal insulin initiated since at least 1 month and no more than 6 months (+ 1 week) before inclusion, reviewed 1 month after the initiation of insulin, during a routine visit in the framework of following his or her diabetes, accepting to participate in the study after information given by the observing doctor. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2008 |
| Date of last collection (YYYY or MM/YYYY) | 2008 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1559 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures |
| Biological data (detail) | Fasting Blood Glucose |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | type-2 diabetes, initiation of insulin therapy, general practice |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) |
Poster SFD 2010 methods for accessing the database are currently being defined |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
