NCT04031300

Brief Summary

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2019

Geographic Reach
4 countries

6 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

Same day

First QC Date

March 26, 2019

Last Update Submit

November 17, 2023

Conditions

Diabetes Mellitus

Keywords

Non-invasive glucose monitoringRaman spectroscopy

Outcome Measures

Primary Outcomes (2)

  • Measurement accuracy

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

    6 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

    6 months

Secondary Outcomes (2)

  • Device deficiencies

    Up to 6 months

  • Device usability

    6 months

Study Arms (1)

RSP-20

EXPERIMENTAL

Subjects will perform daily measurements on the IMD (Prototype 0.5) in addition to capillary reference measurements for 48 days.

Device: Prototype 0.5

Interventions

Prototype 0.5DEVICE

Investigational Medical Device collecting spectral Raman data non-invasively from tissue

Also known as: P0.5
RSP-20

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • 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 the local language
  • 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)
  • Subject diagnosed with cardiovascular diseases
  • Reduced circulation in right hand evaluated by Allen's test
  • Subjects receiving anticoagulants, active cancer treatment, tetracyclines and other medication/topical agents increasing photosensitivity
  • Radiotherapy for the past six months
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Steno Diabetes Center Copenhagen (SDCC)

Gentofte Municipality, 2820, Denmark

Location

Steno Diabetes Center Odense (SDCO)

Odense C, 5000, Denmark

Location

Institut für Diabetes-Technologie Forschungs- und Entwicklungs-gesellschaft mbH an der Universität Ulm (IDT)

Ulm, 89081, Germany

Location

Sahlgrenske University Hospital (SUH)

Gothenburg, 413 45, Sweden

Location

Department of Medicine, Uddevalla Hospital (UVH)

Uddevalla, 451 53, Sweden

Location

University Hospitals Birmingham (UHB)

Birmingham, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kirsten Nørgaard, MD

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

March 26, 2019

First Posted

July 24, 2019

Study Start

June 1, 2019

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)SE(2)GB(1)DE(1)