Tandem Diabetes Care secured expanded CE mark approval in Europe for its Control-IQ automated insulin delivery systems, covering adults with type 2 diabetes and type 1 diabetes during pregnancy. The approvals follow FDA clearance in the US and are supported by clinical trial data showing improved glucose control.
MannKind Corporation announced FDA approval of Afrezza inhaled mealtime insulin for pediatric patients with diabetes ages 6 and older. The approval makes Afrezza the first needle-free mealtime insulin alternative for children in over 100 years. Eligible patients can access Afrezza for $35 or less per month.
Wearable technologies are transforming clinical trials and healthcare with continuous monitoring capabilities, though clinical validation remains limited. While ECG features provide useful data for cardiac monitoring, many wearable metrics lack clinical accuracy and can cause patient anxiety. The technology shows promise for activity tracking and specific medical applications but requires cautious interpretation.
Study of 3600 older adults with type 1 diabetes across US and European registries reveals significant gaps in guideline-recommended cardiovascular therapies and diabetes technology use despite high disease burden.
Portal Diabetes, Inc. announced FDA Breakthrough Device Designation for its implantable insulin pump system and initiated a Phase 1 study of its proprietary temperature-stable insulin for type 1 diabetes treatment.
