ITMO public health
Last update : 08/05/2015 | Version : 3 | ID : 8954
| General | |
| Identification | |
| Detailed name | Longitudinal Study on Diabetic Patients Treated with Detemir Insulin |
| Sign or acronym | PREDICTIVE: Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Endocrinology and metabolism |
| Health determinants |
Genetic |
| Keywords | analogue, determir insulin, efficacy, tolerance |
| Scientific investigator(s) (Contact) | |
| Name of the director | Marre |
| Surname | Michel |
| Address | Faculté de Médecine Xavier Bichat 16 rue Henri Huchard 75870 Paris Cedex 18 |
| Phone | +33 (0)1 44 85 62 28 |
| michel.marre@bch.aphp.fr | |
| Unit | Unité 695 : Déterminants génétiques du diabète de type 2 et de ses complications vasculaires |
| Organization | Inserm |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | - Novo Nordisk A/S. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Institut National de la Santé et de la Recherche Médicale - Inserm |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals |
| Database recruitment is is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | At the discretion of the treating physician. |
| Database objective | |
| Main objective | To investigate the effect of using determir insulin in normal clinical practice. |
| Inclusion criteria |
- Male and female;
- Adult; - Diabetic (type 1 and 2); - Treated with determir insulin. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | Europe (Austria, Denmark, France, Germany, Ireland, Turkey, United Kingdom). |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2006 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 19,911 (Europe): - France (1,772): - 643 patients with type 1 diabetes - 1,129 patients with type 2 diabetes. |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures |
| Details of collected clinical data | -- |
| Biological data (detail) | Glycaemic control |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Visits at baseline, 12 weeks, 26 weeks and 52 weeks. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Pubmed-PREDICTIVE |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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