Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes

Multicentre Performance Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes Randomised to Multiple Devices

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01234727

Enrollment

501

Registered

2010-11-04

Start date

2010-12-01

Completion date

2011-03-01

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

diabetes, SMBG, glucose testing systems, accuracy

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Countries

Germany, Netherlands

Contacts

STUDY_DIRECTORJoe Bugler

Abbott Diabetes Care

Outcome results