Williamsburg

Researchers are evaluating the effectiveness of cadisegliatin as an additional treatment alongside insulin in adults with Type 1 Diabetes Mellitus. This Phase 3 trial focuses on reducing the occurrence of serious hypoglycemia (low blood sugar) events over a 26-week treatment period. The study compares cadisegliatin combined with insulin to a placebo with insulin alone to see if the new treatment lowers the risk of dangerous drops in blood sugar levels. Participants receive either cadisegliatin at a dose of 800 mg once daily, 800 mg twice daily, or a placebo, all as adjunct therapy to their insulin regimen. The study treatment lasts for 26 weeks, during which participants continue their current insulin method, either continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI), without switching. Hybrid closed-loop insulin systems are not allowed. The trial is randomized, double-blind, and placebo-controlled to ensure reliable results. During the study, participants will be monitored for changes in the frequency of Level 2 or Level 3 hypoglycemia events. They must have used a continuous glucose monitoring device for at least three months before screening and maintain stable insulin therapy. Assessments include tracking hypoglycemic episodes, blood glucose levels, and HbA1c values. Safety evaluations and adherence to treatment will be closely observed throughout the 26-week period to understand the impact and safety of cadisegliatin as an adjunct therapy in this population.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.