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

Launched by UNIVERSITY OF WATERLOO · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device that can continuously measure both glucose and ketone levels in people with type 1 diabetes (T1D). Diabetic ketoacidosis (DKA) is a serious condition that can happen when blood sugar and ketone levels get too high, and it’s important for individuals with T1D to monitor these levels closely. Currently, there are limited options for tracking ketone levels continuously, which is why this new device, developed using a special biosensor, could be a game changer. It aims to help keep patients safer by providing real-time information about their glucose and ketone levels.

The study is looking for healthy volunteers aged 18 to 45 who do not have a family history of diabetes. Participants should not be taking any medications (except for birth control), following a low-carb diet, or involved in intense athletic training. Those who have diabetes or certain health conditions like heart or kidney disease will not be eligible. If you participate, you can expect to wear the device and help researchers test its effectiveness in a lab setting. This trial is an important step in finding better ways to manage T1D and could lead to improved safety for those living with this condition.

Gender

ALL

Eligibility 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.