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

NCT06877975 | Recruiting

• 2 other identifiers: 465612-SRA-2022-1167-M-B
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Ketoacidosis

Outcome Measures

Primary Outcomes (1)

• Correlation of the sensor measurement with blood-based measurement

  5 hours

Study Arms (1)

Healthy individuals

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

Sponsors & Collaborators

• University of Waterloo: lead

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

RECRUITING

Related Publications (2)

• GhavamiNejad P, GhavamiNejad A, Zheng H, Dhingra K, Samarikhalaj M, Poudineh M. A Conductive Hydrogel Microneedle-Based Assay Integrating PEDOT:PSS and Ag-Pt Nanoparticles for Real-Time, Enzyme-Less, and Electrochemical Sensing of Glucose. Adv Healthc Mater. 2023 Jan;12(1):e2202362. doi: 10.1002/adhm.202202362. Epub 2022 Oct 13.

  PMID: 36183355 RESULT

• Ausri IR, Sadeghzadeh S, Biswas S, Zheng H, GhavamiNejad P, Huynh MDT, Keyvani F, Shirzadi E, Rahman FA, Quadrilatero J, GhavamiNejad A, Poudineh M. Multifunctional Dopamine-Based Hydrogel Microneedle Electrode for Continuous Ketone Sensing. Adv Mater. 2024 Aug;36(32):e2402009. doi: 10.1002/adma.202402009. Epub 2024 Jun 16.

  PMID: 38847967 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected for glucose and ketone measurement.

Central Study Contacts

Mahla Poudineh

CONTACT

5198884567; mahla.poudineh@uwaterloo.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: March 30, 2025
• Primary Completion: June 30, 2025
• Study Completion: August 30, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)