ITMO public health
Last update : 01/01/2019 | Version : 1 | ID : 88
| General | |
| Identification | |
| Detailed name | Intensification of insulin therapy used in type-2 diabetes patients treated by the association of oral diabetes medication and basal insulin |
| Sign or acronym | INTENSIVE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n°1250160 |
| General Aspects | |
| Medical area |
Endocrinology and metabolism |
| Others (details) | type-2 diabetes |
| Keywords | intensification of insulin therapy |
| 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 institutions and services |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | Describe the evolution of HbA1c at 6 months under different therapeutic strategies for the intensification of insulin therapy used in type-2 diabetes patients treated by the association of oral diabetes medication and basal insulin requiring the adding of rapid insulin |
| Inclusion criteria | man or woman, over the age of 18 years, having type-2 diabetes meeting the criteria of the HAS: treated by the association of oral diabetes medication and basal insulin (semi slow or slow-acting) and requiring the adding of rapid insulin. |
| Population type | |
| Age |
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) | 2009 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 389 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures |
| Biological data (detail) | HbA1c; GAJ |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | type-2 diabetes, intensification of insulin therapy |
| 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) | commented SFD poster. 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 |
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