Noninvasive Glucose Measurements - Database and Calibration Compilation

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03368209

Enrollment

Registered

2017-12-11

Start date

2015-12-04

Completion date

2017-05-07

Last updated

2020-10-08

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

Conditions

Diabetes

Keywords

Non-invasive glucose monitoring

Brief summary

This study collected spectral raman data from diabetic patients. Data was paired with validated capillary references as well as CGM/FGM readings. Data was used to develop models for glucose prediction.

Detailed description

This trial constitutes three subprotocols: The OUH protocol, The Home 1 protocol and The Home 2 protocol The investigation was initiated to collect spectral raman data paired with validated blood references. In the OUH protocol, capillary blood was analysed by ABL 800 Flex blood gas analyzer by Radiometer. In the Home 1 protocol, references were obtained by the finger pricking procedure from HemoCue (Radiometer). In the Home 2 protocol, HemoCue measurements were conducted along with continuous monitoring using Dexcom G4/G5 device (Dexcom) or FreeStyle Libre (Abbott) The data was collected from diabetic patients and Optical Coherence Tomography (OCT) readings were obtained from all subjects.

Interventions

DEVICEWM3.4

Investigational Medical Device collecting spectral raman data from tissue.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

Open, non-randomized comparison study between device and blood references with diabetic patients

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Subjects with and without diabetes including pregnant women

Exclusion criteria

* Subject under 18 years of age * Subjects not able to understand provided information * Subjects without measuring sites * Subjects with rash or wound on measuring sites * Subjects with stained fingers, such a oil or nicotine * Subjects not capable of holding arm/hand steadily on probe * Subjects with thrombosis in arm/hand

Design outcomes

Primary

Measure	Time frame	Description
Calibration models for device predictive purposes	6 months	Spectral raman data paired with validated references used to develop predictive algorithms with glucose prediction capablities. The preformance was validated using the consensus error grid.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026