NCT03352518

Brief Summary

This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

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

November 13, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 28, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2018

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2018

Completed
Last Updated

October 15, 2018

Status Verified

November 1, 2017

Enrollment Period

4 months

First QC Date

November 13, 2017

Last Update Submit

October 12, 2018

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Generation and validation of predictive calibration models

    The collected data will generate individual calibration models capable of predicting tissue glucose concentrations. An evaluation of the models by the consensus error grid will be performed.

    3 months

Secondary Outcomes (1)

  • Safety assessment of the intervention by the paucity of adverse events

    3 months

Study Arms (1)

IMD data collection

EXPERIMENTAL

Subjects will intensively collect spectral raman data in a home-based setting for 5 days using WM3.4NR and comparators.

Device: WM3.4NR

Interventions

WM3.4NRDEVICE

The investigational medical device will collect spectral raman data from tissue.

IMD data collection

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 or older
  • Diabetic patients (all types)

You may not qualify if:

  • Pregnant women
  • Subjects not able to understand and read Danish
  • In investigator's opinion, subject is not able to follow instructions as specified in the protocol
  • Subjects not able to hold hand/arm steadily
  • Extensive skin changes, tattoos or diseases on probe application site
  • Known allergy to medical grade alcohol used to disinfect skin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology M, Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jan Erik Henriksen, MD

    University Hospital Odense

    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

November 13, 2017

First Posted

November 24, 2017

Study Start

December 28, 2017

Primary Completion

April 13, 2018

Study Completion

April 17, 2018

Last Updated

October 15, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)