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A Pilot Study to Assess the Feasibility of a Novel Non-invasive Technology to Measure Changing Blood Glucose Levels in Adults with Type-1 Diabetes Mellitus

NCT06097689 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-10-01

No results posted yet for this study

Summary

The primary aim of this study is to assess the feasibility of the Lab demo 1.0 and associated computational models to detect and track glucose changes noninvasively and transcutaneously in defined and dynamic states of glycemia.

Conditions

  • Type 1 Diabetes Mellitus
  • Type 1 Diabetes Mellitus with Hypoglycemia
  • Type 1 Diabetes Mellitus with Hyperglycemia

Interventions

DEVICE

Lab Demo 1.0

Lowering of the participants blood glucose with the application of insulin to induce hypoglycaemia, followed by the application of glucose to induce hyperglycaemia and finally insulin to restore euglycemia. During the different glycaemia states, transcutaneous spectral data are collected continuously with the device and paired with reference measurements (venous blood and interstitial fluid).

Sponsors & Collaborators

  • DCB Research AG

    collaborator OTHER

  • Liom Health AG

    lead INDUSTRY

Principal Investigators

  • Fabien Rebeaud, PhD · Liom Health AG

  • Markus Laimer, Prof Dr med · University Department of Diabetology, Endocrinology, Nutritional Medicine & Metabolism (UDEM), Inselspital, Bern University Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-24
Primary Completion
2024-05-16
Completion
2024-05-16

Countries

  • Switzerland

Study Locations

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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 NCT06097689 on ClinicalTrials.gov