Search / Trial NCT06223204

GLEAM: Noninvasive Glucose Measurement Using Impedance Tomography

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Jan 15, 2024

Trial Information

Current as of October 08, 2024

Completed

Keywords

Description

Within the GLEAM study, paired samples of EIT and blood glucose measurements will be collected in individuals with type 1 diabetes during standardized euglycemia, hypoglycemia and hyperglycemia. These samples will be used to assess the potential of EIT for noninvasive glucose measurement and/or dysglycemia detection.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * Written, informed consent
  • * Type 1 Diabetes mellitus as defined by WHO for at least 6 months
  • * Aged 18 - 60 years
  • * HbA1c ≤ 9.0 %
  • * Insulin treatment with good knowledge of insulin self-management
  • * Use of a continuous (CGM) or flash glucose monitoring system (FGM)
  • * Native language German or Swiss German
  • Exclusion Criteria:
  • * Incapacity to give informed consent
  • * Contraindications to insulin aspart (NovoRapid®)
  • * Known allergies to adhesives of the EIT device (e.g., gel electrodes)
  • * Pregnancy, breast-feeding or lack of safe contraception
  • * Active heart, lung, liver, gastrointestinal, renal or psychiatric disease
  • * Patients with implantable electronic devices (e.g., pacemaker or implantable cardioverter defibrillator (ICD)) or thoracic metal implants
  • * Epilepsy or history of seizure
  • * Active drug or alcohol abuse
  • * Chronic neurological or ear-nose-and-throat (ENT) disease influencing voice or history of voice disorder
  • * Thoracic or back deformities
  • * Body mass index (BMI) \>35.0 kg/m2
  • * Open wounds, burns, or rashes on the upper thorax
  • * Active smoking
  • * Medication known to interfere with voice or to induce listlessness (e.g., opioids, benzodiazepines, etc.)

About Insel Gruppe Ag, University Hospital Bern

Insel Gruppe AG, the umbrella organization for the University Hospital Bern, is a leading healthcare provider in Switzerland, renowned for its commitment to advancing medical research and patient care. As a key player in clinical trials, Insel Gruppe AG integrates cutting-edge scientific inquiry with clinical excellence, facilitating innovative studies that span a wide range of medical disciplines. The institution prioritizes collaboration with academic partners and industry stakeholders to enhance the understanding of diseases and develop effective treatment options, ultimately aiming to improve patient outcomes and contribute to the global medical community.

Locations

Bern, , Switzerland

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0