Outcomes
birth defects, death, T1D, hypoglycemia, disability
ADVERSE EVENTS, SECONDARY, HYPOGLYCEMIA, EVENT
Outcomes were calculated at the follow-up visit based on data pooled over the 14-day measurement period after the screening visit and the 14 days prior to the final visit. The primary outcome was TIR or the percentage of time during which the glucose level was in the target range of ≥3.9-≤10 mmol/L from baseline to 12 weeks (Secondary outcomes were changes in the percentage of time in which glucose level was in the range of >10.0- ≤13.9 mmol/L, > 13.9 mmol/L, in the range of ≥3.0-<3.9 mmol/L, and <3.0 mmol/L; coefficient of variation (CV); standard deviation (SD) and mean amplitude of glycemic excursions (MAGE); and HbA1c. The other secondary outcomes included patient-reported outcomes, namely, changes in daily dietary calories and proportions of carbohydrates and fat; changes in the number of daily steps; and changes in the SDSCA, DDS, HFS-II, and HCS scores.The safety objective was to evaluate the safety of wearing the FreeStyle Libre Flash Glucose Monitoring System device in patients with T1D. Reportable adverse events included severe hypoglycemia (defined as an event that required assistance from another person due to altered consciousness), adverse events regardless of causality, and serious adverse events that require hospitalization, prolong hospitalization, cause disability, endanger life or result in death, or result in birth defects.