MedTrace Logo

SKAMo-2: the Real-life Test of Continuous Photoacoustic Signal by Neogly in Patients With Type I Diabetes

NCT06035367 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-09-13

No results posted yet for this study

Summary

Diabetes is one of the very common and chronic diseases in the present world, which affects children and adults. Diabetes is characterized by hyperglycemia. Hence, diabetic patients need to precisely monitor their blood sugar level regularly a few times a day. Currently, the solutions for self-monitoring blood glucose are invasive (finger prick method, continuous glucose monitoring (CGM) using microneedle).The fully non-invasive CGM approaches still are in high demand.

The medical device is developed, ultimately, to continuously measure the blood glucose level from continuous in-vivo photoacoustic signal.

For this study, the goal is to check if the signal collected by the investigational device is relevant and exploitable in patients with type I diabetes.

The main task of participants is to wear the investigational device during one week.

Conditions

Interventions

DEVICE

Non-invasive continuous monitoring device to record photoacoustic signal

Neogly is in two parts, the measurement head, to be worn on the wrist and the power box, to be worn on the forearm or upper arm. The ribbon cable makes the connection between the two parts. A handset is used to start/stop the device. The medical device record a continuous photoacoustic signal.

Sponsors & Collaborators

  • Eclypia

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-07-06
Primary Completion
2023-10-30
Completion
2023-10-30

Countries

  • France

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 NCT06035367 on ClinicalTrials.gov