Ketone Monitoring for Type 1 Diabetes

(KARMA Trial)

This trial aims to determine if a special education plan using a device for continuous ketone monitoring can lower the risk of diabetic ketoacidosis (DKA), a serious complication, in people with type 1 diabetes who use medications typically prescribed for type 2 diabetes, such as Sotagliflozin. The trial compares this plan to a general education plan to assess which is more effective. Participants should have type 1 diabetes, use insulin regularly, and be willing to use the provided monitoring device.

As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in diabetes care.

The trial does not specify if you need to stop taking your current medications. However, you cannot have used SGLT2 inhibitors within 4 weeks before the trial starts.

Research has shown that sotagliflozin, when combined with insulin for type 1 diabetes, is generally safe but carries some risks. It significantly reduces the likelihood of heart problems, which is a major benefit. However, the risk of developing diabetic ketoacidosis (DKA), a serious condition, was higher for those taking sotagliflozin compared to a placebo, with 3.0% of patients experiencing it.

Unlike the standard of care for Type 1 diabetes, which typically involves insulin therapy, sotagliflozin is unique because it targets both SGLT1 and SGLT2 proteins, which play roles in glucose absorption and reabsorption in the kidneys. This dual inhibition has the potential to improve blood sugar control and reduce the risk of diabetic ketoacidosis, a dangerous complication. Researchers are excited about sotagliflozin because it offers a new way to manage blood sugar levels and could provide additional benefits beyond what insulin alone can offer.

Studies have shown that sotagliflozin can help manage type 1 diabetes (T1D) by improving blood sugar control. It lowers A1c levels, a measure of average blood sugar over time. Research also indicates that it aids in weight loss and maintains steady blood pressure. Additionally, sotagliflozin reduces the risk of heart-related problems. Patients using sotagliflozin have reported spending more time with their blood sugar in the target range, which is crucial for managing diabetes. These benefits make sotagliflozin a promising option for people with T1D.¹²³⁶⁷