Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes
This study has been completed.
Sponsor:
Abbott Diabetes Care
Collaborator:
ikfe-CRO GmbH
Information provided by:
Abbott Diabetes Care
ClinicalTrials.gov Identifier:
NCT01234727
First received: November 3, 2010
Last updated: July 4, 2011
Last verified: March 2011
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Purpose
A Multicentre study comparing 5 different Self-Monitoring Of Blood Glucose (SMBG) system commercially available in Germany & Holland.
| Condition |
|---|
|
Diabetes Mellitus |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Multicentre Performance Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes Randomised to Multiple Devices |
Resource links provided by NLM:
Further study details as provided by Abbott Diabetes Care:
| Enrollment: | 501 |
| Study Start Date: | December 2010 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Diabetes
Patients with Type 1 or Type 2 diabetes requiring insulin.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Up to 480 subjects with type 1 or 2 diabetes mellitus
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234727
Locations
| Germany | |
| Zentrum für Diabetes und Gefäßerkrankungen | |
| Münster, Germany, 48145 | |
| Diabetes Zentrum Neuwied | |
| Neuwied, Germany, 56564 | |
| Netherlands | |
| Radboud University Nijmegen Centre | |
| Nijmegen, Netherlands, 6500 HB | |
Sponsors and Collaborators
Abbott Diabetes Care
ikfe-CRO GmbH
Investigators
| Study Director: | Joe Bugler | Abbott Diabetes Care |
More Information
No publications provided
| Responsible Party: | Harald Pohlmeier, Zentrum für Diabetes und Gefäßerkrankungen |
| ClinicalTrials.gov Identifier: | NCT01234727 History of Changes |
| Other Study ID Numbers: | ADC-MKG-FSL-10008 |
| Study First Received: | November 3, 2010 |
| Last Updated: | July 4, 2011 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Abbott Diabetes Care:
|
diabetes, SMBG, glucose testing systems, accuracy |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013