Trial Files: CGM in Older Patients with T1DM, Left Atrial Appendage Closure after Ablation for AFib and Alteplase for Posterior Circulation Ischemic Stroke at 4.5-24 Hrs
Continuous Glucose Monitoring With Geriatric Principles in Older Adults With Type 1 Diabetes and Hypoglycemia: A Randomized Controlled Trial
Munshi MN et al. Diabetes Care (September 2024)
Bottom Line: This randomized controlled trial included 131 older adults (≥65 years) with type 1 diabetes (T1D) and high risk of hypoglycemia. Participants were randomized to either the intervention group, which received continuous glucose monitoring (CGM) use with geriatric principles (adjusting goals and simplifying regimens based on CGM patterns and clinical characteristics) for 6 months, or the control group, which received usual care by their endocrinologist. The primary outcome was change in time when blood glucose was <70 mg/dL (3.9 mmol/L) from baseline to 6 months. The intervention group showed a statistically significant reduction in hypoglycemia compared to the control group, with a median change of -2.6% in the intervention group and −0.3% in the control group (median difference, −2.3% [95% CI −3.7%, −1.3%]; P < 0.001). The intervention was also found to be cost-effective. Overall, using CGM with geriatric principles can effectively lower hypoglycemia without worsening glycemic control in older adults with T1D and high risk of hypoglycemia.
Left Atrial Appendage Closure after Ablation for Atrial Fibrillation: The OPTION Trial
Wazni OM et al. The New England Journal Of Medicine (November 2024)
Bottom line: This international randomized trial evaluated the efficacy and safety of left atrial appendage closure compared to oral anticoagulation in 1600 patients with atrial fibrillation at high stroke risk, with a follow-up duration of 36 months. Patients were randomly assigned to receive either intervention in a 1:1 ratio. The primary efficacy outcome, a composite of death, stroke, or systemic embolism, showed 5.3% in the closure group versus 5.8% in the anticoagulation group (P<0.001 for noninferiority). The primary safety outcome revealed 8.5% of patients in the closure group experienced bleeding events compared to 18.1% in the anticoagulation group (P<0.001 for superiority). The conclusion indicates that left atrial appendage closure is a viable alternative to anticoagulation with favorable safety outcomes.
Alteplase for Posterior Circulation Ischemic Stroke at 4.5 to 24 Hours
Yan S et al. The New England Journal of Medicine (April 2025)
Bottom Line: This randomized clinical trial evaluated the effects of intravenous alteplase versus standard medical treatment in 234 patients with posterior circulation ischemic stroke, conducted in China. The study assessed functional independence at 90 days as the primary outcome and found that 89.6% of the alteplase group achieved this compared to 72.6% in the comparator group (adjusted risk ratio 1.16; 95% CI, 1.03 to 1.30; P = 0.01). Safety outcomes included symptomatic intracranial hemorrhage (1.7% vs. 0.9%) and mortality (5.2% vs. 8.5%). The findings suggest that alteplase improves functional independence in this patient population.
Trial Files Issue #2025-11
Want to view past issues? Visit our archive:
