Study to explore how accurately the CNOGA Combo glucose meter and the MTX meter measure blood sugar, blood pressure and other important body information when people are eating a meal

Evaluation of the CNOGA Combo glucometer and the MTX non-invasive body signaling device during a standardized meal test in patients with diabetes mellitus and in healthy subjects in comparison with point-of-care reference methods for the respective parameters

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN33202080

Enrollment

Registered

2018-05-24

Start date

2017-07-15

Completion date

Unknown

Last updated

2018-06-18

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

Conditions

Accuracy of devices in measuring health-related parameters in people with diabetes mellitus and healthy people Nutritional, Metabolic, Endocrine Diabetes mellitus

Interventions

The participants are trained to use the CNOGA Comboglycometer or the MTX Multimarker devices and will calibrate them for 1 week at home with multiple comparative measurements with an invasive blood su

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Type 1 diabetes mellitus or type 2 diabetes mellitus or healthy subjects 2. Aged 18-80 years

Exclusion criteria

Exclusion criteria: 1. Subjects requiring dialysis 2. Any conditions that may hamper good visual contact between the finger and sensor, such as raised birthmarks, scars, tattoos 3. Pregnancy 4. Nursing mothers 5. Any skin scratch(es) on the measured finger 6. Diagnosis of HIV infection or hepatitis

Design outcomes

Secondary

Measure	Time frame
1. Mean observed difference between the invasive blood sugar measurement with the CNOGA device and the reference method during the trial site visit 2. Comparison of long-term sugar control (HbA1c) at baseline and after 3 months 3. Other body signals (blood pressure, pulse, tissue oxygenation and others) will be measured with the non-invasive MTX device and compared to clinical reference methods during the meal experiment	—

Measure

Time frame

1. Mean observed difference between the invasive blood sugar measurement with the CNOGA device and the reference method during the trial site visit 2. Comparison of long-term sugar control (HbA1c) at baseline and after 3 months 3. Other body signals (blood pressure, pulse, tissue oxygenation and others) will be measured with the non-invasive MTX device and compared to clinical reference methods during the meal experiment

—

Primary

Measure	Time frame
The primary outcome parameter is the mean observed difference between the non-invasive sugar measurements with the CNOGA ComboGlucometer and the reference method during the trial site visit.	—

Countries

Germany

Outcome results

None listed

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