Testing a new device for continuous glucose and ketone monitoring in healthy individuals
Validation and Testing of a Novel CGM-CKM Device in Healthy Volunteers
University of Waterloo · NCT06877975
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 type | Observational |
|---|---|
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of Waterloo (other) |
| Locations | 1 site (Waterloo, Ontario) |
| Trial ID | NCT06877975 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy volunteers aged 18 to 45 with no family history of diabetes.
Not a fit: Patients with a history of diabetes, hypertension, cardiovascular disease, kidney disease, or thyroid disorders will not benefit from this study.
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 performed: While continuous glucose monitoring has seen success, the continuous monitoring of ketone bodies is a relatively novel approach with limited prior studies.
Eligibility criteria
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 this trial is running
Waterloo, Ontario
- University of Waterloo — Waterloo, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: Mahla Poudineh
- Email: mahla.poudineh@uwaterloo.ca
- Phone: 5198884567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Ketoacidosis