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 type | Observational |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 16 (estimated) |
| Sponsor | University of Waterloo Academic / other |
| Locations | 1 site (Waterloo, Ontario) |
| Status | Recruiting |
| Started | March 30, 2025 |
| Main results expected | June 30, 2025 |
| Study ends | August 30, 2025 |
| Registry record updated | March 14, 2025 |
| Trial ID | NCT06877975 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
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University of Waterloo
Waterloo, Ontario, Canada Recruiting
Study contacts
- Study coordinator: Mahla Poudineh
- Email: mahla.poudineh@uwaterloo.ca
- Phone: 5198884567
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study tests whether the perfusion index measured at ED admission can help predict how severe diabetic ketoacidosis will be in adults.
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Markers of early kidney and heart injury in children newly diagnosed with type 1 diabetes
This study will test whether blood markers and heart ultrasound can find early kidney or heart injury in children aged 2–16 who are newly diagnosed with type 1 diabetes, comparing those with diabetic ketoacidosis, those without, and healthy children.
-
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Intravenous arginine to help treat diabetic ketoacidosis in people with type 2 diabetes
This study tests whether a single IV dose of arginine given early in DKA can safely boost your own insulin and help adults with ketone-prone type 2 diabetes recover faster.
-
Using REAMBERIN® for treating diabetic ketoacidosis
This study is testing if adding a new treatment called REAMBERIN® to standard care can help people with diabetic ketoacidosis recover faster and leave the hospital sooner.
-
Evaluating serum ferritin levels in patients with diabetic ketoacidosis
This study is testing if measuring ferritin levels in adults with diabetic ketoacidosis can help predict how severe their condition is and what their short-term outcomes might be.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.