Noninvasive Glucose Measurements - Database and Calibration Compilation

Not Applicable

Terminated

• Conditions: Diabetes
• Interventions: Device: WM3.4

• Registration Number: NCT03368209
• Lead Sponsor: RSP Systems A/S

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.

Study Timeline

• Study Start: 2015-12-04
• Primary Completion: 2017-05-07
• Study Completion: 2017-05-07
• Study First Submitted: 2017-11-22
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-11
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home 2 protocol	WM3.4	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.
Home 1 protocol	WM3.4	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.
OUH protocol	WM3.4	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Endocrinology M, Odense University Hospital; 🇩🇰 Odense, Denmark