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Assessment of potential drug and substance interference on the performance of the CNOGA TensorTip blood glucose measuring device

Clinical assessment of potential drug and substance interference on the performance of the CNOGA TensorTip COMBO GLUCOMETER (CoG)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN67040922
Enrollment
10
Registered
2019-05-13
Start date
2018-11-01
Completion date
Unknown
Last updated
2020-03-03

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

Conditions

diabetes Nutritional, Metabolic, Endocrine

Interventions

All participants will get an introduction to the TENSORTIP COG (MP) and one device will be individually assigned. This is followed by a week of calibration by the participants at home. All calibration

Sponsors

CNOGA Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy subjects verified by safety chemistry and blood count 2. Able to complete and understand informed consent form (by him/herself or by his/her guardian) 3. 18 years old and above 4. No constant treatment with medication 5. Safety biochemistry and blood count with exclusively values in normal range

Exclusion criteria

Exclusion criteria: 1. Severe life-threatening disease 2. Anatomical conditions that may hamper good contact between the device and the measured finger, at the discretion of the investigator 3. Pregnancy 4. Nursing mothers 5. Healthy volunteers with a hypersensitivity to any of the tested interferents 6. History of alcoholism (anamnestic exclusion)

Design outcomes

Primary

MeasureTime frame
Influence of different drugs and/or nutritional supplements on the result of the non-invasive glucose measuring CoG device measured weekly over 10-weeks.

Secondary

MeasureTime frame
1. Impact of different drugs and/or nutritional supplements on the results of the invasive CoG device in comparison to the YSI reference method 2. Impact of different drugs and/or nutritional supplements on the results of the YSI device in comparison to a standard laboratory method.

Countries

Germany

Outcome results

None listed

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