Validation and Testing of a Novel Continuous Glucose and Continuous Ketone Monitoring Device in Healthy Volunteers

March 10, 2025 updated by: Mahla Poudineh, University of Waterloo

Validation and Testing of a Novel CGM-CKM Device in Healthy Volunteers

Diabetic ketoacidosis (DKA) is a severe complication of type 1 diabetes (T1D) that can have life-threatening consequences. It occurs when there is a high level of glucose in the blood and the body produces excessive amounts of ketone bodies. To manage this condition, individuals with T1D need to constantly monitor their levels of ketone bodies and glucose. While continuous glucose monitoring (CGM) devices have made significant advancements in providing non-invasive or minimally invasive glucose measurements, there has been little progress in developing methods for continuous monitoring of ketone bodies (CKM). Currently, the commonly used approaches involve self monitoring with commercially available blood or urine strips. However, these tools have limited adoption, provide only single time point measurements, and can be costly for some patients.

In our project, which is funded by Breakthrough T1D (2-SRA-2022-1167-M-B), we address this challenge by utilizing a minimally invasive biosensor based on hydrogel microneedle (HMN). This biosensor enables simultaneous and continuous measurement of the primary biomarker for ketone formation, 3-β hydroxybutyrate (β-HB), as well as glucose levels. By doing so, we intend to reduce the risk of diabetic ketoacidosis in patients with T1D. We plan to test the developed CGM-CKM device on human subjects, including both healthy volunteers (HV) and patients with T1D. The HV testing will take place at the laboratory of Dr. Poudineh and Dr. Devries-Aboud in Waterloo, while the validation involving patients with T1D will be conducted in collaboration with Dr. Lal at Stanford.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

16

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 Locations

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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers (HVs) will be between 18 and 45 years old and with no family history of Diabetes (T1D or T2D, specifically biological parents and siblings).

Description

The age range for the healthy volunteers (HVs) will be between 18 and 45 years old and with no family history of Diabetes (T1D or T2D, specifically biological parents and siblings).

Exclusion criteria included: (i) currently taking any medications (except for birth control for females); (ii) following a low-carbohydrate diet or consuming nutritional ketone supplements; (iii) considered competitive athlete engaged in competition or intensive training, (iv) have been diagnosed with Diabetes (T1D or T2D), hypertension, cardiovascular disease, kidney disease, and thyroid disorder. (v) Having an allergy to any of the ingredients in the products used in the study, which will be explained to you in detail.

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

Cohorts and Interventions

Group / Cohort
Healthy individuals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation of the sensor measurement with blood-based measurement
Time Frame: 5 hours
5 hours

Collaborators and Investigators

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

Sponsor

University of Waterloo

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

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 (Estimated)

March 30, 2025

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46561
  • 2-SRA-2022-1167-M-B (Other Grant/Funding Number: Breakthrough T1D)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sensor measurements and blood glucose and ketone levels will be shared via publications.

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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