Noninvasive Glucose Measurements - Database and Calibration Compilation

NCT ID: NCT03368209

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-04
• Study Completion Date: 2017-05-07

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.

Conditions

Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

OUH protocol

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.

Group Type: EXPERIMENTAL

WM3.4

Intervention Type: DEVICE

Investigational Medical Device collecting spectral raman data from tissue.

Home 1 protocol

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.

Group Type: EXPERIMENTAL

WM3.4

Intervention Type: DEVICE

Investigational Medical Device collecting spectral raman data from tissue.

Home 2 protocol

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.

Group Type: EXPERIMENTAL

WM3.4

Intervention Type: DEVICE

Investigational Medical Device collecting spectral raman data from tissue.

Interventions

WM3.4

Investigational Medical Device collecting spectral raman data from tissue.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RSP Systems A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Erik Henriksen, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital, Dpt. of Endocrinology M

Locations

Department of Endocrinology M, Odense University Hospital

Odense, , Denmark

Countries

Denmark

Other Identifiers

RSP-07

Identifier Type: -

Identifier Source: org_study_id