Early Real-World Performance of the MiniMed™ 780G Advanced Hybrid Closed-Loop System and Recommended Settings Use in the United States.

The MiniMed™ 780G system (MM780G) with Guardian™ 4 sensor includes a 100 mg/dL glucose target (GT) and automated insulin corrections up to every 5 min and was recently approved for use in the United States. In the present study, early real-world MM780G performance and the use of recommended system settings (100 mg/dL GT with an active insulin time of 2 h), by individuals with type 1 diabetes, were evaluated. CareLink™ personal data uploaded between the launch of the MM780G to August 22, 2023 were aggregated and underwent retrospective analysis (based on user consent) and if users had ≥10 days of continuous glucose monitoring (CGM) data.

Chapter 4: Summary and a Patient Perspective on Living with Heart Failure.

This chapter is intended to provide a plain language overview of heart failure suitable for non-medical professionals, including patients and caregivers, and a patient perspective on living with heart failure.

Safety and Glycemic Outcomes During the MiniMed Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes.

During MiniMed™ advanced hybrid closed-loop (AHCL) use by adolescents and adults in the pivotal trial, glycated hemoglobin (A1C) was significantly reduced, time spent in range (TIR) was significantly increased, and there were no episodes of severe hypoglycemia or diabetic ketoacidosis (DKA). The present study investigated the same primary safety and effectiveness endpoints during AHCL use by a younger cohort with type 1 diabetes (T1D). An intention-to-treat population ( = 160, aged 7-17 years) with T1D was enrolled in a single-arm study at 13 investigational centers.

Glycemic Outcomes During Early Use of the MiniMed™ 780G Advanced Hybrid Closed-Loop System with Guardian™ 4 Sensor.

Safety and significant improvement in overall glycated hemoglobin (A1C) and percentage of time spent in (TIR), below (TBR), and above (TAR) glucose range were demonstrated in the pivotal trial of adolescents and adults using the MiniMed™ advanced hybrid closed-loop (AHCL) system with the adjunctive, calibration-required Guardian™ Sensor 3. The present study evaluated early outcomes of continued access study (CAS) participants who transitioned from the pivotal trial investigational system to the approved MiniMed™ 780G system with the non-adjunctive, calibration-free Guardian™ 4 Sensor (MM780G+G4S). Study data were presented alongside those of real-world MM780G+G4S users from Europe, the Middle East, and Africa.

Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes.

This trial assessed safety and effectiveness of an advanced hybrid closed-loop (AHCL) system with automated basal (Auto Basal) and automated bolus correction (Auto Correction) in adolescents and adults with type 1 diabetes (T1D). This multicenter single-arm study involved an intent-to-treat population of 157 individuals (39 adolescents aged 14-21 years and 118 adults aged ≥22-75 years) with T1D. Study participants used the MiniMed™ AHCL system during a baseline run-in period in which sensor-augmented pump +/- predictive low glucose management or Auto Basal was enabled for ∼14 days.

Predictors of Hypoglycemia in the ASPIRE In-Home Study and Effects of Automatic Suspension of Insulin Delivery.

Background: Hypoglycemia varies between patients with type 1 diabetes and is the main obstacle to therapy intensification. We investigated known and potential risk factors for hypoglycemia in subjects with type 1 diabetes.

Method: In the ASPIRE In-Home study (NCT01497938), a randomized trial of the threshold suspend (TS) feature of sensor-augmented insulin pump (SAP) therapy, subjects' propensity to nocturnal hypoglycemia (NH) was established in a 2-week run-in phase and assessed in a 3-month study phase via continuous glucose monitoring.