Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes

Abbott

Status: Completed

Conditions: Diabetes Mellitus

Study type: Observational

Funder types: Industry

Identifiers

NCT01234727

ADC-MKG-FSL-10008

Details and patient eligibility

About

A Multicentre study comparing 5 different Self-Monitoring Of Blood Glucose (SMBG) system commercially available in Germany & Holland.

Enrollment: 501 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects diagnosed with type 1 or type 2 diabetes mellitus
• Age between 18 and 75 years.
• Patients with stable blood glucose in judgment of the investigator.
• Subjects receive intensive insulin therapy (Multiple Daily Injection defined as at least two insulin injections per day)
• Patients perform blood glucose self measurements on a routine basis
• Patients must have experience in self measurement blood glucose for at least 6 months.

Exclusion criteria

• Patients with unstable blood glucose in judgment of the investigator.
• Patient has been diagnosed with progressive / serious diseases that in judgment of the investigator preclude successful completion of the observational period.
• Lack of compliance or other justifications that, in the discretion of the investigator, precludes satisfactory participation in the study.
• Subject without legal capacity.
• Blood donation within the last 30 days.
• Known pregnancy.
• Subject has already participated in the study.

Trial design

501 participants in 1 patient group

Diabetes

Description:

Patients with Type 1 or Type 2 diabetes requiring insulin.