Translating Biometric Data Into Blood Glucose Levels

July 15, 2021 updated by: Scimita Operations Pty Ltd.

Non-invasive Monitoring to Translate the Biometric Data of Participants With Diabetes Into Blood Glucose Levels

This study is designed to assist with the development of a first, truly non-invasive technology for blood glucose monitoring, which will have the potential to eliminate the need for painful finger pricking or expensive continuous blood glucose monitor use. The purpose of this study is to collect biometric data, such as bioimpedance (how well the body impedes electric current flow), from participants who are living with type 2 diabetes. A proof-of-concept prototype (non-invasive continuous glucose monitor; NI-CGM) will be used to collect this biometric data. The data will then be used to develop and refine a computer model that can be used to predict blood glucose levels (BGLs). Individuals with diabetes experience a great range of blood BGLs throughout their daily life and activities, therefore it is essential to gather biometric data corresponding to this large range to build a computer model, to ensure model reliability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted over a two-week period where the participants are required to wear the prototype, that will continuously collect the biometric data. Participants are required to use this device together with two existing commercially available blood glucose meters that are considered management routine for diabetes (an Abbott FreeStyle Libre and an Accu-Chek® Mobile), throughout the duration of the study. The majority of the study is carried out independently, by the participants, where they wear the prototype throughout their daily life and activities. The data collected from the non-invasive custom-built device and the existing blood glucose meters will be used to develop a computer model that will allow for blood glucose levels to be predicted, over time.

The study will not interfere with any of the participants' diabetes management plans provided to them, by their regular doctor, under regular care, such as medications, diet and current use of blood glucose monitoring.

It is hypothesised that the bioimoedance data collected using the non-invasive prototype device, in conjunction with existing devices used in diabetes management, will enable the development of a computer model that allows for blood glucose levels to be predicted in people with type 2 diabetes.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • 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 Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2044
        • Scimita Operations

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

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 - 70 years
  • Physician diagnosis of Type 2 diabetes
  • Haemoglobin A1c (HbA1c) range between 7 - 10%
  • Body mass index between 20 - 40
  • Regularly eats 3 meals per day (breakfast, lunch, and dinner)
  • Technologically literate (e.g. able to use Apps, smart phones)
  • Able to commit to attending the Sponsor site
  • Able to commit to wearing a non-invasive, custom-built device through most daily activities
  • Currently self-monitoring their BGL and able to commit to taking measurements at least 6 times per day
  • Proficiency in reading and writing in English

Exclusion Criteria:

  • Currently on insulin therapy (other than long-acting insulin therapy)
  • Currently pregnant, pregnant in the last 6 months, or planning a pregnancy
  • Currently breastfeeding
  • Current smoker
  • Any other confounding major disease or condition as deemed appropriate by investigator, determined by review of medical history and/or patient reported medical history
  • Clinically unstable or rapidly progressing diabetic retinopathy, neuropathy, and/or frequent nausea, bloating or vomiting, sever gastroesophageal reflux, or early satiety.
  • Multiple medications (taking more than 10 medications is often an indicator of having multiple major comorbidities which is an exclusion criteria. Furthermore, we want to exclude potential multiple drug interactions with blood glucose levels which may impact results of study)
  • Currently on active curative treatments for cancer
  • Currently receiving systemic glucocorticoid therapy
  • Using lipid-lowering medication at a dose that has not been stable for the past 3 months
  • History of reactions to alcohol wipes, antiseptics, or adhesives (isobornyl acrylate which is the adhesive used for attachment of Freestyle Libre sensors and may cause contact dermatitis)
  • Using an insulin pump
  • Pacemaker fitted
  • Fasting C-peptide levels below 0.5 ng/mL or above 2.0 ng/mL
  • Has had an episode of diabetic ketoacidosis in the past 6 months
  • Has had an episode of severe hypoglycemia within the past 6 months
  • Currently unstable blood glucose control
  • Receiving dialysis treatment
  • Has had a blood transfusion or severe blood loss within the past 3 months
  • Unwilling to self-monitor their BGL (at least 6 measurement, daily)
  • Currently participating in another clinical study
  • Known to the Investigators
  • Other investigator-determined criteria making participants unsuitable for participation

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
Intervention / Treatment
Experimental: Opuz NICGM
Participants will be provided with one non-invasive, custom-built prototype device (study device), which they will use throughout their day-to-day life/activities over the study period.
Device: Opuz NICGM
A wearable and non-invasive prototype device that allows for measurement of bioimpedance data with the aim to help develop a mathematical model to predict blood glucose levels.
Other Names:
  • Opuz Device
  • Opuz Ring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generation of a predictive models for determining blood glucose levels
Time Frame: at 14 days post introduction of intervention
Performance of computer models for blood glucose level estimation using collected bioimpedance spectroscopy data.
at 14 days post introduction of intervention
Validation of predictive model for determining blood glucose levels
Time Frame: at 14 days post introduction of intervention
Performance of predictive models will be evaluated using the consensus error grid. Mean Absolute Relative Difference (MARD) and Consensus Error Grid (CEG) distribution.
at 14 days post introduction of intervention

Collaborators and Investigators

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

Sponsor

Scimita Operations Pty Ltd.

Investigators

  • Principal Investigator: Thomas Telfer, PhD (Med), Scimita Operations
  • Study Chair: Farid Sanai, PhD (Med), Scimita Operations

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

July 21, 2020

Primary Completion (Actual)

December 14, 2020

Study Completion (Actual)

December 14, 2020

Study Registration Dates

First Submitted

April 22, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 30, 2021

Study Record Updates

Last Update Posted (Actual)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-02-099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All data have already gone through a careful process of de-identification. Data can be made available after study completion for the purposes of further research, and to develop and validate the model after quality checks and Secondary analyses. Data will be available to all investigators who provide a sound proposal, as well case-by-case basis at the discretion of Primary Sponsor and PI Dr Thomas Telfer.

IPD Sharing Time Frame

De-identified data is expected to be available after study completion and following publication of results, with no determined end date.

IPD Sharing Access Criteria

Data obtained from this study will be made available after approval from PI Dr Thomas Telfer.

Scimita ventures t.telfer@scimitaventures.com

+61 481848190

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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