ITMO public health
Last update : 07/23/2015 | Version : 3 | ID : 67
| General | |
| Identification | |
| Detailed name | CHOICE: CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy |
| Sign or acronym | CHOICE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL N°908226 |
| General Aspects | |
| Medical area |
Endocrinology and metabolism |
| Keywords | Type-2 diabetes, insulin, exenatide, undesirable effects, HbA1c, quality of life |
| Scientific investigator(s) (Contact) | |
| Name of the director | Laboratoire |
| fr_mail_pharmacoepi@lilly.com | |
| Unit | Eli Lilly France |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Eli Lilly and Company |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Eli Lilly |
| Organisation status |
Private |
| 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 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 |
| Additional information regarding sample selection. | Diabetologists and general practitioners. Random selection of practitioners using files.Patients initiating a treatment via insulin or exenatide |
| Database objective | |
| Main objective | The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time. |
| Inclusion criteria |
- Adults 18 years and older,
- Type-2 diabetes patients who have never received insulin or exenatide and who are initiating a treatment via exenatide or insulin therapy, within the normal routine course of care. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | France, Deutschland, Sweden, Denmark, Belgium and Greece |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2008 |
| Date of last collection (YYYY or MM/YYYY) | 2012 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 2388 (1114 exenatide, 1274 insulin) |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire |
| Biological data (detail) | HbA1c, glycemia, lipid profile, renal function (if available) |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Data collection notebook and questionnaires |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 2 years follow-up |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Hal-CHOICE |
| Description | List of publications in HAL |
| Link to the document | http://tinyurl.com/Pubmed-CHOICE |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Reports and publications |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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