A Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

Novo Nordisk

Status: Completed

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

Treatments: Other: No treatment given

Study type: Observational

Funder types: Industry

Identifiers

NCT02230631

U1111-1147-4179 (Other Identifier)

INS-4142

Details and patient eligibility

About

This survey is conducted in South America. The aim of this survey is to investigate hypoglycaemia among Insulin-treated patients with diabetes.

Enrollment: 704 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent obtained before any study-related activities
• The following patients will be considered eligible for inclusion in the study: Patients with T1DM (Type 1 Diabetes Mellitus) or T2DM (Type 2 Diabetes Mellitus) treated with insulin for more than 12 months and patients at least 18 years of age at the time of the survey

Exclusion criteria

• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
• Illiterate patients and patients otherwise unable to complete a written survey
• Non-ambulatory patients
• Simultaneous participation in any other clinical study with an investigational product

Trial design

704 participants in 2 patient groups

Part 1 (retrospective cross-sectional evaluation)

Treatment:

Other: No treatment given

Part 2 (prospective observational evaluation)

Treatment:

Other: No treatment given