Noninvasive Glucose Measurements - Database and Calibration Compilation

Diabetes Clinical Trial

Official title:

Noninvasive Glucose Measurements - Database and Calibration Compilation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03368209
• Other study ID #: RSP-07
• Status: Terminated
• Phase: N/A
• Start date: December 4, 2015
• Est. completion date: May 7, 2017

Study information

• Verified date: October 2020
• Source: RSP Systems A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: May 7, 2017
• Est. primary completion date: May 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• WM3.4
Investigational Medical Device collecting spectral raman data from tissue.

Locations

Country	Name	City	State
Denmark	Department of Endocrinology M, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
RSP Systems A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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