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Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes

NCT04126759 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-10-08

No results posted yet for this study

Summary

This clinical study has been launched to collect spectral Raman data and reference measurements to establish and validate a calibration model for the device during daily glycemic fluctuations and evaluate analytical performance of device in the hypoglycemic range. The study is a combined home-based and in-clinic study where subjects will attend the clinic two times.

Conditions

Interventions

DEVICE

P0.3

Subjects will perform daily measurements on the IMD (Prototype 0.3) for 35 days.

Sponsors & Collaborators

  • Steno Diabetes Center Copenhagen

    collaborator OTHER

  • RSP Systems A/S

    lead INDUSTRY

Principal Investigators

  • Kirsten Nørgaard · Steno Diabetes Center Copenhagen

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04126759 on ClinicalTrials.gov