French Observational Survey to Assess Hypoglycaemia in Insulin-treated Diabetic Patients (DIALOG)

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin

Study type: Observational

Funder types: Industry

Identifiers

NCT01628341

INS-3988

U1111-1131-8540 (Other Identifier)

Details and patient eligibility

About

This non-interventional study is conducted in Europe. The study is both retrospective and prospective.

The purpose of the study is to assess the frequency of hypoglycaemia (low blood glucose) in insulin-treated patients with type 1 and type 2 diabetes.

Enrollment: 4,424 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Type 1 or Type 2 Diabetes Mellitus
• Patients treated by insulin for at least 12 months
• Patients able to perform capillary self-monitoring plasma glucose (SMPG) measurements
• Patients able to complete the questionnaires
• Patients who have accepted to participate to the survey (signature of an information notice)

Exclusion criteria

• Patients with Type 2 Diabetes Mellitus not treated with insulin
• Females who are currently pregnant or lactating or who were pregnant during the previous year

Trial design

4,424 participants in 1 patient group

Patients with diabetes (type 1 and 2)

Treatment:

Drug: insulin