GLEAM: Noninvasive Glucose Measurement Using Impedance Tomography (GLEAM)

April 30, 2024 updated by: Insel Gruppe AG, University Hospital Bern

GLEAM: Noninvasive Glucose Measurement Using Impedance Tomography - a Pilot Project

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Controlled euglycemia, hypoglycemia and hyperglycemia
Other: Controlled euglycemia, hypoglycemia and hyperglycemia
EIT measurements are collected in different glycemic states (euglycemia, hypoglycemia and hyperglycemia). Venous blood glucose is measured using a gold-standard glucose analyzer.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of the electrical impedance tomography (EIT) signal of the thoracic region across the glycemic trajectory.
Time Frame: 5 hours
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of hypoglycemia symptoms across the glycemic trajectory.
Time Frame: 5 hours
Hypoglycemia symptoms will be collected in euglycemia, hypoglycemia and hyperglycemia using a standardized questionnaire (Edinburgh Hypoglycemia Scale, a higher score means more symptoms, minimum score 7 points, maximum score 77 points).
5 hours
Voice parameters indicative of dysglycemia
Time Frame: 5 hours
Voice data will be collected using a microphone in euglycemia, hypoglycemia and hyperglycemia. After sampling, an interpretable machine learning (ML) method will be used to identify voice parameters indicative of dysglycemia.
5 hours
Change in cognitive performance across the glycemic trajectory.
Time Frame: 5 hours
Cognitive performance will be assessed using the Trail Making B Test (more time needed to complete the tests means worse cognitive performance).
5 hours
Change in cognitive performance across the glycemic trajectory.
Time Frame: 5 hours
Cognitive performance will be assessed using the Digit Symbol Substitution Test (higher score means better cognitive performance).
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).
Time Frame: 5 hours
Signals for machine learning modeling will be collected in euglycemia, hypoglycemia and hyperglycemia.
5 hours
Performance of a machine learning model to detect dysglycemia from the above-mentioned signals (EIT, symptoms, voice, physiological signals) quantified as sensitivity.
Time Frame: 5 hours
Signals for machine learning modeling will be collected in euglycemia, hypoglycemia and hyperglycemia.
5 hours
Performance of a machine learning model to detect dysglycemia from the above-mentioned signals (EIT, symptoms, voice, physiological signals) quantified as specificity.
Time Frame: 5 hours
Signals for machine learning modeling will be collected in euglycemia, hypoglycemia and hyperglycemia.
5 hours
Performance of the machine learning model to predict glucose values from the above-mentioned signals (EIT, symptoms, voice, physiological signals) quantified as root mean squared error (RMSE).
Time Frame: 5 hours
Signals for machine learning modeling will be collected in euglycemia, hypoglycemia and hyperglycemia.
5 hours
Performance of the machine learning model to predict glucose values from the above-mentioned signals (EIT, symptoms, voice, physiological signals) quantified as mean absolute relative difference (MARD).
Time Frame: 5 hours
Signals for machine learning modeling will be collected in euglycemia, hypoglycemia and hyperglycemia.
5 hours
Performance of the machine learning model to predict glucose values from the above-mentioned signals (EIT, symptoms, voice, physiological signals) using Bland-Altman plots.
Time Frame: 5 hours
Signals for machine learning modeling will be collected in euglycemia, hypoglycemia and hyperglycemia.
5 hours
Performance of the machine learning model to predict glucose values from the above-mentioned signals (EIT, symptoms, voice, physiological signals) using the Clarke Error Grid.
Time Frame: 5 hours
Signals for machine learning modeling will be collected in euglycemia, hypoglycemia and hyperglycemia.
5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Insel Gruppe AG, University Hospital Bern

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Idiap Research Institute
CSEM Centre Suisse d'Electronique et de Microtechnique SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christoph Stettler, Prof. MD, Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism; Bern, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GLEAM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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