Noninvasive Glucose Measurements - Database and Calibration Compilation

NCT03368209 | Terminated

• 1 other identifier: RSP-07
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Non-invasive glucose monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

OUH protocol

EXPERIMENTAL

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

Home 1 protocol

EXPERIMENTAL

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

Home 2 protocol

EXPERIMENTAL

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

Interventions

WM3.4 DEVICE

Investigational Medical Device collecting spectral raman data from tissue.

Home 1 protocol; Home 2 protocol; OUH protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with and without diabetes including pregnant women

You may not qualify if:

• 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

Sponsors & Collaborators

• RSP Systems A/S: lead

Study Sites (1)

Department of Endocrinology M, Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jan Erik Henriksen, MD

  Odense University Hospital, Dpt. of Endocrinology M

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 11, 2017
• Study Start: December 4, 2015
• Primary Completion: May 7, 2017
• Study Completion: May 7, 2017
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)