GLEAM: Noninvasive Glucose Measurement Using Impedance Tomography

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

Keywords

ClinConnect Summary

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.)