Study to measure how well the Tensortip Combo Glucometer can measure blood glucose with finger-pricks

System accuracy of the invasive part of the Tensortip Combo glucometer (CoG) – clinical trial protocol in accordance with ISO15197:2015

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12167086

Enrollment

100

Registered

2018-05-24

Start date

2017-07-20

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

Accuracy of glucometer in determining blood glucose levels in patients with diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes mellitus

Interventions

After enrollment and device calibration at home during the following week, patients will come to the study site for a single comparative blood glucose testing experiment. The patients check their gluc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 1 diabetes or type 2 diabetes or healthy

Exclusion criteria

Exclusion criteria: 1. Not able to perform study at the discretion of investigator 2. Uptake of high doses of vitamin C 3. Uptake of acetylsalicylic acid 4. Inability to operate device

Design outcomes

Primary

Measure	Time frame
The bias between the results obtained with the invasive TensorTip CoG component from the mean reference results will be calculated and the data pairs will be analyzed by means of a consensus-error-grid analysis according to Parkes et al., 2000.	—

Secondary

Measure	Time frame
The bias between the results obtained with the non-invasive TensorTip CoG component from the mean reference results will be calculated and the data pairs will be analyzed by means of a consensus-error-grid analysis according to Parkes et al., 2000	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026