GLEAM: Noninvasive Glucose Measurement Using Impedance Tomography

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Other: Controlled euglycemia, hypoglycemia and hyperglycemia

Study type: Interventional

Funder types: Other

Identifiers

NCT06223204

GLEAM

Details and patient eligibility

About

The GLEAM study aims at assessing the potential of electrical impedance tomography (EIT) for noninvasive glucose measurement.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Controlled euglycemia, hypoglycemia and hyperglycemia

Other group

Treatment:

Other: Controlled euglycemia, hypoglycemia and hyperglycemia