An observational study in Diabetes Ketoacidosis, sponsored by University of Waterloo. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by University of Waterloo · Observational
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.
218 studies on the registry are indexed under Ketosis; 50 are open to participants now.
This study's planned enrollment of 16 is below the median of 58 across 23 observational studies indexed under Ketosis.
Browse Ketosis studies →University of Waterloo is the lead sponsor of 90 studies on the registry; 7 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.
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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).
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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Correlation of the sensor measurement with blood-based measurement
Time frame: 5 hours
Plan to share: Yes — Sensor measurements and blood glucose and ketone levels will be shared via publications.
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University of Waterloo