Continuous Ketone Monitoring in People With Type 1 Diabetes Using SGLT2 Inhibitors

Launched by MCGILL UNIVERSITY · Dec 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how continuous monitoring of ketone levels can help people with type 1 diabetes who are using a medication called empagliflozin. In type 1 diabetes, the body can't produce insulin, which is needed to manage blood sugar levels. When insulin is low, the body makes ketones for energy, but if ketone levels get too high, it can lead to a serious condition called diabetic ketoacidosis. This trial aims to see if continuous ketone monitoring can help keep ketone levels safe, especially during exercise and low-carbohydrate diets, while using empagliflozin, which is typically for type 2 diabetes but shows promise for type 1 diabetes as well.

To be eligible for the study, participants need to be at least 18 years old and have been diagnosed with type 1 diabetes for at least a year, among other criteria. Participants will use a device to continuously monitor their ketone levels for several weeks while taking different doses of empagliflozin. They will also have the opportunity to engage in exercise and follow a low-carbohydrate diet during the study. This research is important because it could help understand how to safely use higher doses of empagliflozin in people with type 1 diabetes, potentially leading to better blood sugar control and reduced risks of complications.

Gender

ALL

Eligibility 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.