Monitoring ketone levels in people with Type 1 diabetes using SGLT2 inhibitors
Continuous Ketone Monitoring in Participants With Type 1 Diabetes (T1D) Using SGLT2 Inhibitors as Adjunctive Therapy
This study is testing if using a continuous ketone monitor can help adults with Type 1 diabetes who take SGLT2 inhibitors, like empagliflozin, by checking how these medications affect their ketone levels and risk of diabetic ketoacidosis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06753994 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of continuous ketone monitoring (CKM) in adults with Type 1 diabetes who are treated with SGLT2 inhibitors, specifically empagliflozin. The study aims to assess how these medications affect ketone levels and the risk of diabetic ketoacidosis, a serious complication of diabetes. Participants will be adults aged 18 and older who have been diagnosed with Type 1 diabetes for at least one year and are currently using intensive insulin therapy. The trial will involve monitoring ketone levels continuously to better understand the relationship between SGLT2 inhibitors and ketone production.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of Type 1 diabetes for at least one year who are currently using intensive insulin therapy.
Not a fit: Patients who have experienced diabetic ketoacidosis or severe hypoglycemia within the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help improve the safety and management of Type 1 diabetes by providing better monitoring of ketone levels and reducing the risk of diabetic ketoacidosis.
How similar studies have performed: While the use of SGLT2 inhibitors in Type 1 diabetes is relatively novel, there have been studies indicating potential benefits, though this specific approach to continuous ketone monitoring is less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Adults ≥ 18 years old. * A T1D diagnosis for at least one year, as per their treating physician in agreement with the investigator's judgment (confirmatory C-peptide and antibodies will not be required). * HbA1c level of \< 11% within the last six months. * Current use of intensive insulin therapy, either multi-daily injection or closed-loop insulin pump therapy, with no plan to change during the study. * Current use of CGM, either real-time or intermittent. * Active avoidance of pregnancy during the trial, which includes effective contraception for any individuals of childbearing potential, who are sexually active. * Ability to consume an average of more than 50 g of carbohydrates per day. * Use of a compatible phone to allow for download of the CKM sensor application. Exclusion Criteria: * DKA or severe hypoglycemia within the last six months. * Current or recent use of any anti-hyperglycemic agent other than insulin (≤ one month for GLP1-RA, ≤ one week for all others). * Current or ≤ one-month use of supraphysiological doses of glucocorticoids. * Body mass index \< 20 kg/m2. * Glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 as per CKD-EPI formula with creatinine levels measured within the last two months.
Where this trial is running
Montreal, Quebec
- Hygea Medical Clinic — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Michael Tsoukas, M.D. — Clinique Medicale Hygea
- Study coordinator: Linden Perz, Bachelor of Medical Sciences
- Email: linden.perz@mail.mcgill.ca
- Phone: 5144045621
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.