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Clinical Trials/NCT03368209
NCT03368209TerminatedNot Applicable

Noninvasive Glucose Measurements - Database and Calibration Compilation

RSP Systems A/S2 sites in 1 country62 target enrollmentStarted: December 4, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
62
Locations
2
Primary Endpoint
Calibration models for device predictive purposes

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Calibration models for device predictive purposes

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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