Clinical trial Recruiting at 1 site Observational Ages 18 to 45

Testing a new device for continuous glucose and ketone monitoring in healthy individuals

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

Run by University of Waterloo · NCT06877975 · Data updated 2026-11-12

This study is testing a new device that continuously checks glucose and ketone levels in healthy people to see if it can help manage diabetes better and prevent serious complications.

Quick facts

Study typeObservational
Ages18 Years to 45 Years
SexAll
Enrollment16 (estimated)
SponsorUniversity of Waterloo
Academic / other
Locations1 site (Waterloo, Ontario)
StatusRecruiting
StartedMarch 30, 2025
Main results expectedJune 30, 2025
Study endsAugust 30, 2025
Registry record updatedMarch 14, 2025
Trial IDNCT06877975 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are healthy volunteers aged 18 to 45 with no family history of diabetes.

Probably not a fit

Patients with a history of diabetes, hypertension, cardiovascular disease, kidney disease, or thyroid disorders will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to validate and test a novel device designed for continuous monitoring of glucose and ketone levels in healthy volunteers. It addresses the challenges faced by individuals with type 1 diabetes in managing diabetic ketoacidosis, a serious complication that arises from high glucose and ketone levels. The device is minimally invasive and seeks to improve upon current methods that rely on single time point measurements through blood or urine strips. By providing continuous data, the device could enhance the management of diabetes and potentially prevent severe complications.

Why it matters

Potential benefit: If successful, this device could significantly improve the monitoring and management of diabetic ketoacidosis in individuals with type 1 diabetes.

How similar studies have gone: While continuous glucose monitoring has seen success, the continuous monitoring of ketone bodies is a relatively novel approach with limited prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • University of Waterloo
    Waterloo, Ontario, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.