Post-approval study designed to collect primarily safety data on the US FDA-cleared product, t:slim X2 insulin pump with Control-IQ technology (Control-IQ system), by assessing the rate of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) during the first 12 months of use. Secondary endpoints assessing the effectiveness of this product in real-world use by assessing the impact on patients' glycemic outcomes and user experience will also be collected. The Control-IQ system will be used as intended and in accordance with FDA-approved labeling.
Post-approval study designed to collect primarily safety data on the US FDA-cleared product, t:slim X2 insulin pump with Control-IQ technology (Control-IQ system).