Performance Evaluation of a Novel Non-invasive Glucometer, Calibrated Against Validated Interstitial Glucose References

NCT03782649 | Completed

• 1 other identifier: RSP-08
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study has been launched to collect spectral Raman data on the Investigational Medical Device (IMD) compared with reference methods in terms of interstitial fluid samples and capillary and venous references.

Conditions

Diabetes Mellitus

Keywords

Non-invasive glucose monitoring; Raman spectroscopy

Outcome Measures

Primary Outcomes (3)

• Generation and validation of prediction models - MARD

  Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected. Optical glucose readings will be masked to the subjects. Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Mean Absolute Relative Difference (MARD) endpoint measure.

  One year

• Generation and validation of prediction models - ISUP

  Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected. Optical glucose readings will be masked to the subjects. Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Inter Subject Unified Performance (ISUP) measure.

  One year

• Generation and validation of prediction models - Consensus Error Grid

  Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected. Optical glucose readings will be masked to the subjects. Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Consensus Error Grid Analysis

  One year

Secondary Outcomes (2)

• Evaluation of dynamics between arterial and venous glucose profiles in relation to interstitial glucose levels

  One year

• Safety evaluation: paucity of adverse events

  One year

Study Arms (1)

RSP-08

EXPERIMENTAL

All subjects undergo the same procedures. Subjects will be subjected to measurements on the IMD (Working Model 3.4NR), FreeStyle Libre, Dexcom, microdialysis, venous and capillary blood collection.

Device: Working Model 3.4NR

Interventions

Working Model 3.4NR DEVICE

Investigational Medical Device collecting spectral Raman data from tissue

RSP-08

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects 18-70 years old
• Patients diagnosed with type 1 or type 2 diabetes (T1D or T2D) (insulin requiring T2D patients)
• Diabetes management strategy: lifestyle regimen + insulin ± oral hypoglycemic agents
• Skin phototype 1-4

You may not qualify if:

• For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
• \> 10 cigarettes pr. day
• Participants not able to understand and read Swedish
• In investigator's opinion, participant is not able to follow instructions as specified in the protocol
• Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
• Diagnosed with reduced circulation
• Extensive skin changes, tattoos or diseases on probe application site
• Rejection by screening optical measurements
• Known allergy to medical grade alcohol
• Known allergy to adhesives
• Systemic or topical administration of glucocorticoids for the past 7 days
• Participants undergoing dialysis treatment
• Anti-coagulation or anti-platelet therapy
• Use of beta-blockers
• Medical conditions causing bleeding tendency

Sponsors & Collaborators

• RSP Systems A/S: lead

Study Sites (1)

Gothia Forum för Klinisk Forskning, Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Per-Anders Jansson, MD

  Sahlgrenska Universitetssjukhuset, Gothenburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 20, 2018
• Study Start: November 29, 2018
• Primary Completion: June 19, 2019
• Study Completion: June 19, 2019
• Last Updated: December 12, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)