Study of a Novel Non-invasive Glucose Monitoring Device

NCT03782441 | Completed

• 1 other identifier: RSP-19
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This explorative clinical study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.

Conditions

Diabetes Mellitus

Keywords

Non-invasive glucose monitoring; Raman spectroscopy

Outcome Measures

Primary Outcomes (2)

• Measurement accuracy of IMD

  Accuracy of measurements performed on the IMD will be evaluated by data from subjects. Data will be analyzed by Mean Absolute Relative Difference (MARD) and Inter Subject Unified Performance (ISUP)

  4 months

• Safety evaluation: paucity of adverse events

  Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical study

  4 months

Secondary Outcomes (2)

• Device deficiency

  4 months

• Device usability

  4 months

Study Arms (1)

RSP-19

EXPERIMENTAL

Subjects will perform daily measurements on the IMD (Prototype 0.5) for 42 days.

Device: Prototype 0.5

Interventions

Prototype 0.5 DEVICE

Investigational Medical Device collecting spectral Raman data from tissue

RSP-19

Eligibility Criteria

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

You may qualify if:

• Male and female subjects ≥18 years of age
• Diagnosed with diabetes, all types except gestational diabetes
• HbA1c distribution \> 60 mmol/mol at baseline visit
• Skin phototype 1-4
• Willing to perform a minimum of 8 finger sticks during each day of home-based measurements and 30 finger sticks at the two in-clinic study days
• Subject has a wireless internet connection at home to be used in the study

You may not qualify if:

• For female subjects: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
• For female subjects: Breastfeeding
• Subject currently participating in another study
• Subject not able to understand and read Danish
• In investigator's opinion, subject is not able to follow instructions provided and as specified in the protocol
• Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease)
• Reduced circulation in right hand evaluated by Allen's test
• Extensive skin changes, tattoos or diseases on right hand thenar (probe application site)
• Known allergy to medical grade alcohol used to clean the skin
• Medical history or any condition that may, in the opinion of the investigator compromise the subject's ability to participate
• Comorbidity or concomitant medical condition which, in the opinion of the Investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff

Sponsors & Collaborators

• RSP Systems A/S: lead

Study Sites (1)

Steno Diabetes Center Aarhus

Aarhus, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Sanne Fisker

  Steno Diabetes Center, Aarhus University Hospital

  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 18, 2018
• First Posted: December 20, 2018
• Study Start: November 5, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 3, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)