Noninvasive Glucose Measurements - Database and Calibration Compilation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Noninvasive Glucose Measurements - Database and Calibration Compilation

Conditions
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Diabetes

Intervention / Treatment
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* Device: WM3.4


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open, non-randomized comparison study between device and blood references with diabetic patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OUH protocol<br>The protocol constituted two outpatient visits in the clinic within one week. Each visit had a duration of approximately 2,5 hours. Prior to study, optical screenings were conducted: Optical Coherence Tomography (OCT) Optical screening on measuring site with WM3.4. Subjects were measured by the following scheme: ABL measurement, two optical measurements on WM3.4 #1 followed by two optical measurements on WM3.4 #2. | Device: WM3.4<br>* Investigational Medical Device collecting spectral raman data from tissue.<br>|
| Experimental: Home 1 protocol<br>Optical screening (OCT and device) was conducted at baseline visit in the Department of Endocrinology M at Odense University Hospital. WM3.4 was subsequently delivered to subject's home and the subject measured 30 days in a 60 days period of time. HemoCue was used for reference. | Device: WM3.4<br>* Investigational Medical Device collecting spectral raman data from tissue.<br>|
| Experimental: Home 2 protocol<br>Optical screening (OCT and device) was conducted at baseline visit in the Department of Endocrinology M at Odense University Hospital. WM3.4 was subsequently delivered to subject's home and the subject measured 30 days in a 60 days period of time. HemoCue and CGM/FGM was used for reference. | Device: WM3.4<br>* Investigational Medical Device collecting spectral raman data from tissue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calibration models for device predictive purposes | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-invasive glucose monitoring