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Study to assess the contribution of various blood samples and sampling techniques to the performance of a Self Monitoring Blood Glucose System.

In patients with type 1 or 2 diabetes, how do glucose results from a Self Monitoring Blood Glucose System correlate with that of a standard laboratory reference using different sampling techniques.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000957099
Enrollment
100
Registered
2010-11-09
Start date
2011-01-15
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

This study will involve taking a venous sample from the same venepuncture uses as a part of their normal routine treatment and an additional two capillary finger stick samples from all participants. Samples collected are tested on both the medical device and the laboratory reference.

Interventions

The aim of this study is to measure glucose levels in persons currently being treated for type 1 or 2 diabetes. Each participant will be required to donate 1 venous whole blood sample additional to their routine treatment and two capillary finger stick samples which are not performed as a part of their normal treatment. Venous and capillary blood samples will be tested directly on a self monitoring blood glucose system as well as a reference method. Results from the self monitoring blood gluc

The aim of this study is to measure glucose levels in persons currently being treated for type 1 or 2 diabetes. Each participant will be required to donate 1 venous whole blood sample additional to their routine treatment and two capillary finger stick samples which are not performed as a part of their normal treatment. Venous and capillary blood samples will be tested directly on a self monitoring blood glucose system as well as a reference method. Results from the self monitoring blood glucose system will be analysed in comparison to the reference method. No clinical decision will be made from data generated using the investigational device. Participants will be recruited over 10 days.

Sponsors

Universal Biosensors Pty Ltd
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients are required to be currently treated for type 1 or 2 diabetes and require a venous blood sample as part of their routine treatment.

Exclusion criteria

Pregnant females, completed a D-Xylose Gut Absorption test within the last 2 days. Haematocrit and glucose to be within the acceptable range of the device

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026