Effectiveness of noninvasive continuous glucose monitoring using OCT angiography-purified blood scattering signals

A pilot study on noninvasive continuous glucose monitoring in healthy subjects using OCT angiography-purified blood scattering signals

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN73626753

Enrollment

Registered

2023-08-16

Start date

2022-12-01

Completion date

Unknown

Last updated

2023-08-28

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

Conditions

Continuous glucose monitoring Nutritional, Metabolic, Endocrine

Interventions

Experimental group: Each test involved a 10-minute baseline period, followed by the ingestion of a glucose solution for 5 minutes and an 85-minute recovery period to return to baseline levels. OCTA im

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults (18 years old or above) 2. In good health 3. Not taking any medication 4. Able to consent to participate

Exclusion criteria

Exclusion criteria: 1. Children and young adults (younger than 18 years old) 2. Having chronic disease 3. Unable to consent to participate

Design outcomes

Primary

Measure	Time frame
1. 3D OCT structure images and 3D OCT angiography (OCTA) images of skin. The 3D OCT structure images of human skin were acquired by the swept source OCT system, and 3D OCTA images were generated by applying the inverse signal-to-noise ratio and decorrelation OCTA (ID-OCTA) algorithm on the 3D OCT structure at -10, -5, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 min 2. Reference blood glucose concentrations (BGC) were measured every 10 minutes using a portable blood glucose meter on a sample taken from the finger at -10, 0, 10, 20, 30, 40, 50, 60, 70, 80 and 90 min	—

Measure

Time frame

1. 3D OCT structure images and 3D OCT angiography (OCTA) images of skin. The 3D OCT structure images of human skin were acquired by the swept source OCT system, and 3D OCTA images were generated by applying the inverse signal-to-noise ratio and decorrelation OCTA (ID-OCTA) algorithm on the 3D OCT structure at -10, -5, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 min 2. Reference blood glucose concentrations (BGC) were measured every 10 minutes using a portable blood glucose meter on a sample taken from the finger at -10, 0, 10, 20, 30, 40, 50, 60, 70, 80 and 90 min

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Secondary

Measure	Time frame
1. Blood optical scattering coefficient (BOC) extracted from the depth attenuation of backscattered light in OCT and then spatially purified under the guidance of a 3D OCTA vascular map in human skin at -10, -5, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 min 2. Correlation between BOC and reference blood glucose concentrations (BGC), linearly fitted based on the least squares criterion at -10, 0, 10, 20, 30, 40, 50, 60, 70, 80 and 90 min 3. Optical BGC, calculated from the BOC through a linear calibration at -10, 0, 10, 20, 30, 40, 50, 60, 70, 80 and 90 min 4. Accuracy of glucose measurements based on OCT angiography (OCTA), evaluated using Parke's error grid, ISO 15197 standards, and mean absolute relative difference at -10, 0, 10, 20, 30, 40, 50, 60, 70, 80 and 90 min 5. Tissue optical scattering coefficient (TOC), extracted from the depth attenuation of backscattered light in OCT and then spatially purified under the guidance of a 3D OCTA vascular map in the dermis layer of the skin at -10, -5, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 min 6. Correlation between TOC and reference blood glucose concentrations (BGC), linearly fitted based on the least squares criterion at -10, 0, 10, 20, 30, 40, 50, 60, 70, 80 and 90 min 7. Optical interstitial fluid glucose concentration (IGC), calculated from the TOC through a linear calibration at -10, 0, 10, 20, 30, 40, 50, 60, 70, 80 and 90 min 8. Lag time between IGC and BGC, assessed as the temporal delay between optical IGC and the reference BGC at -10, -5, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 min	—

Measure

Time frame

1. Blood optical scattering coefficient (BOC) extracted from the depth attenuation of backscattered light in OCT and then spatially purified under the guidance of a 3D OCTA vascular map in human skin at -10, -5, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 min 2. Correlation between BOC and reference blood glucose concentrations (BGC), linearly fitted based on the least squares criterion at -10, 0, 10, 20, 30, 40, 50, 60, 70, 80 and 90 min 3. Optical BGC, calculated from the BOC through a linear calibration at -10, 0, 10, 20, 30, 40, 50, 60, 70, 80 and 90 min 4. Accuracy of glucose measurements based on OCT angiography (OCTA), evaluated using Parke's error grid, ISO 15197 standards, and mean absolute relative difference at -10, 0, 10, 20, 30, 40, 50, 60, 70, 80 and 90 min 5. Tissue optical scattering coefficient (TOC), extracted from the depth attenuation of backscattered light in OCT and then spatially purified under the guidance of a 3D OCTA vascular map in the dermis layer of the skin at -10, -5, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 min 6. Correlation between TOC and reference blood glucose concentrations (BGC), linearly fitted based on the least squares criterion at -10, 0, 10, 20, 30, 40, 50, 60, 70, 80 and 90 min 7. Optical interstitial fluid glucose concentration (IGC), calculated from the TOC through a linear calibration at -10, 0, 10, 20, 30, 40, 50, 60, 70, 80 and 90 min 8. Lag time between IGC and BGC, assessed as the temporal delay between optical IGC and the reference BGC at -10, -5, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 min

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Countries

China

Outcome results

None listed

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