Association Between Glycaemic Control and Morbi/Mortality After 5 Years of Follow-up in Type 2 Diabetic Patients

Association Pour la Recherche en Diabetologie et en Geriatrie

Status: Unknown

Conditions: Type 2 Diabetes

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01282060

CRO0662-1

Details and patient eligibility

About

The purpose of this study is to asses the link between glycaemic balance (summarised by HBA1C LEVEL) and specific causes of death.

Full description

The GERODIAB study is the first prospective, longitudinal follow-up cohort study, the main aim of which is to assess the link between glycaemic balance (evaluated on the basis of HbA1c levels) and total mortality at 5 years in diabetic patients aged 70 and over, and suffering from type 2 diabetes. An extension to 10 years is considered given the innovative features of this cohort follow-up procedure.

The secondary endpoints are as follows:

• To assess the link between glycaemic balance and the mortality rate with specific causes.
• To assess the link between glycaemic balance and the onset of or change in diabetes-related complications: cardiovascular diseases, change in renal function, diabetic retinopathy, peripheral neuropathy, perforating ulcer of the foot and acute metabolic complications.
• To assess the link between glycaemic balance and nutritional status, the onset of or changes in cognitive disorders and a loss of autonomy.
• To specify the role of other cardiovascular risk factors combined with glycaemic balance, in mortality, diabetes-related complications, cognitive disorders and loss of autonomy.

Enrollment: 986 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with type 2 diabetes, aged 70 and over,
• Patient having received medicinal or non-medicinal treatment (in the case of diabetics treated with insulin, the length of time between diagnosis of diabetes and the onset of insulin therapy will be at least 2 years),
• Diabetes diagnosed for at least one year,
• Patient with autonomy defined by a score greater than or equal to 3/6 on the ADL scale,
• Patient who can be monitored during hospital or private consultations over the next 10 years,
• Patient who did not refuse to take part in the study after receiving information on the study (Patient Information Leaflet), Patients are monitored in the hospital or private sector throughout France.

Exclusion criteria

• Patient with type 1 diabetes,
• Patient with secondary diabetes (mainly corticosteroid-induced),
• Patient with a loss of autonomy defined by a score of less than 3/6 on the ADL scale,
• Patient who cannot be monitored in the months or years to come,
• Patient in an acute situation (transient exclusion criterion),
• Patient expressing their refusal to participate in the study.