Testing a non-invasive smartphone application to predict sugar levels in the blood

Intermediate type 2 diabetes trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15977623

Enrollment

Registered

2022-06-27

Start date

2022-04-20

Completion date

Unknown

Last updated

2022-08-05

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

Conditions

Type 2 diabetes Nutritional, Metabolic, Endocrine

Interventions

The Bioepic system is a non-invasive technology that is designed to predict blood glucose levels, using artificial intelligence, from a 30-second fingertip video recorded by the camera of a smartphone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetes

Exclusion criteria

Exclusion criteria: 1. Body mass index 160mmHg systolic or >95 mmHg diastolic) 11. Severe renal impairment (eGFR<15ml/min)

Design outcomes

Primary

Measure	Time frame
Estimated blood glucose levels measured using the Bioepic System, a pre-loaded smartphone App (Enne Health) that characterises an approximation of blood glucose by taking a Photoplethysmography (PPG) video of the fingertip, falling within zones A and B of the Consensus error grid and therefore meeting the minimum criteria for acceptable system accuracy in 100 paired glucose readings taken at home over a 30 day period (3-6 readings per day) plus 6 readings on the active study day, 15 minutes apart. To compare the blood glucose levels derived from the Bioepic App with the glucose values measured by a standard blood glucometer via a finger-prick test the simultaneous App glucose and the glucometer result are paired to facilitate analysis. The accuracy of the App values will be assessed against the internationally agreed standard according to the Consensus error grid, aiming to demonstrate that at least 99% of App values will lie within zones A and B of the Consensus error grid, which would be in line with requirements for all blood glucose monitors for patient use.	—

Measure

Time frame

Estimated blood glucose levels measured using the Bioepic System, a pre-loaded smartphone App (Enne Health) that characterises an approximation of blood glucose by taking a Photoplethysmography (PPG) video of the fingertip, falling within zones A and B of the Consensus error grid and therefore meeting the minimum criteria for acceptable system accuracy in 100 paired glucose readings taken at home over a 30 day period (3-6 readings per day) plus 6 readings on the active study day, 15 minutes apart. To compare the blood glucose levels derived from the Bioepic App with the glucose values measured by a standard blood glucometer via a finger-prick test the simultaneous App glucose and the glucometer result are paired to facilitate analysis. The accuracy of the App values will be assessed against the internationally agreed standard according to the Consensus error grid, aiming to demonstrate that at least 99% of App values will lie within zones A and B of the Consensus error grid, which would be in line with requirements for all blood glucose monitors for patient use.

—

Secondary

Measure	Time frame
The percentage of predicted glucose levels from the Bioepic App System meeting the minimum criteria for acceptable system accuracy when grouped by certain criteria: 1. Glucose level, as measured by 100 paired blood glucose readings taken at home over a 30 day period (3-6 readings per day) plus 6 readings on the active study day, 15 minutes apart 2. Glycated haemoglobin (HbA1c) level, as measured in mmol/mol by laboratory immunoassay within the previous 3 months of commencing the study 3. Demographics – including weight, age, as measured in Kg by standard scales at the beginning of the study 4. Daily activity and other participant daily log conditions, as measured by patient recall (light, medium or heavy exercise) at the beginning of the study	—

Measure

Time frame

The percentage of predicted glucose levels from the Bioepic App System meeting the minimum criteria for acceptable system accuracy when grouped by certain criteria: 1. Glucose level, as measured by 100 paired blood glucose readings taken at home over a 30 day period (3-6 readings per day) plus 6 readings on the active study day, 15 minutes apart 2. Glycated haemoglobin (HbA1c) level, as measured in mmol/mol by laboratory immunoassay within the previous 3 months of commencing the study 3. Demographics – including weight, age, as measured in Kg by standard scales at the beginning of the study 4. Daily activity and other participant daily log conditions, as measured by patient recall (light, medium or heavy exercise) at the beginning of the study

—

Countries

England, United Kingdom

Outcome results

None listed

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