NCT06223204

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

January 31, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2024

Completed
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

December 19, 2023

Last Update Submit

April 30, 2024

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change of the electrical impedance tomography (EIT) signal of the thoracic region across the glycemic trajectory.

    EIT signals will be collected at multiple frequencies between 50 kHz and 1 MHz from the thoracic region in euglycemia, hypoglycemia and hyperglycemia using a multi-channel EIT measurement device.

    5 hours

Secondary Outcomes (11)

  • Change of hypoglycemia symptoms across the glycemic trajectory.

    5 hours

  • Voice parameters indicative of dysglycemia

    5 hours

  • Change in cognitive performance across the glycemic trajectory.

    5 hours

  • Change in cognitive performance across the glycemic trajectory.

    5 hours

  • Performance of a machine learning model to detect dysglycemia from the above-mentioned signals (EIT, symptoms, voice, physiological signals) quantified as area under the receiver operating characteristics curve (AUROC).

    5 hours

  • +6 more secondary outcomes

Study Arms (1)

Controlled euglycemia, hypoglycemia and hyperglycemia

OTHER
Other: Controlled euglycemia, hypoglycemia and hyperglycemia

Interventions

Controlled euglycemia, hypoglycemia and hyperglycemiaOTHER

EIT measurements are collected in different glycemic states (euglycemia, hypoglycemia and hyperglycemia). Venous blood glucose is measured using a gold-standard glucose analyzer.

Controlled euglycemia, hypoglycemia and hyperglycemia

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism

Bern, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Christoph Stettler, Prof. MD

    Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism; Bern, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 25, 2024

Study Start

January 31, 2024

Primary Completion

April 10, 2024

Study Completion

April 10, 2024

Last Updated

May 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)