PREDICTIVE: Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation - Longitudinal Study on Diabetic Patients Treated with Detemir Insulin

Head :
Marre Michel, Unité 695 : Déterminants génétiques du diabète de type 2 et de ses complications vasculaires

Last update : 08/05/2015 | Version : 3 | ID : 8954

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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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
Email 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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