Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes

NCT01234727 | Completed

• 1 other identifier: ADC-MKG-FSL-10008
• Study Type: observational
• Target: 501
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Diabetes Mellitus

Keywords

diabetes, SMBG, glucose testing systems, accuracy

Study Arms (1)

Diabetes

Patients with Type 1 or Type 2 diabetes requiring insulin.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 480 subjects with type 1 or 2 diabetes mellitus

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Diabetes Care: lead
• ikfe-CRO GmbH: collaborator

Study Sites (3)

Zentrum für Diabetes und Gefäßerkrankungen

Münster, 48145, Germany

Location

Diabetes Zentrum Neuwied

Neuwied, 56564, Germany

Location

Radboud University Nijmegen Centre

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (1)

• Tack C, Pohlmeier H, Behnke T, Schmid V, Grenningloh M, Forst T, Pfutzner A. Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: a European multicenter study with 453 subjects. Diabetes Technol Ther. 2012 Apr;14(4):330-7. doi: 10.1089/dia.2011.0170. Epub 2011 Dec 16.

  PMID: 22176154 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Joe Bugler

  Abbott Diabetes Care

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: November 4, 2010
• Study Start: December 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

NL (1); DE (2)