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Values will be given mean (SD) or as median (IQR) for each treatment (closed loop or sensor augmented pump therapy).
During sensor augmented pump therapy, participants will enter the information directly into the bolus calculator residing on insulin pump.
A recent trial by Ly et al reported that sensor augmented pump therapy with automated insulin suspension reduced the rate of moderate and severe hypoglycemia, as well as impaired hypoglycemia awareness over a 6-month period in trial participants.
The smartphone uploads data on a server using a 3G/GSM communication to ease data transfer and downloads data from study devices during the sensor augmented pump therapy when the closed-loop control is disabled.
The respective values obtained during the 3 months randomised interventions contrasting the closed-loop system against the sensor augmented pump therapy will be compared using a regression model that accounts for period effect.
Two hundred and four (94%) of the patients on the sensor-augmented pump continued their initial augmented pump therapy, while 190 (93%) of the subjects on multiple daily injections decided to cross over to the sensor-augmented pump group.
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A recent randomized controlled trial named Sensor-Augmented Pump Therapy for A1C Reduction 3 (STAR 3) comparing sensor-augmented pump therapy with multiple-injection therapy demonstrated a significant reduction of HbA1c in adults and children without an increase in hypoglycemia (22).
The safety and efficacy of the sensor-augmented pump was evaluated in the 1-year randomized phase of the Sensor-Augmented Pump Therapy for A1C Reduction (STAR) 3 study in patients with type 1 diabetes.
The sensor-augmented pump (SAP) system combines insulin pump and continuous glucose monitoring (CGM) technologies, and its efficacy was studied in the 1-year randomized phase of the Sensor-Augmented Pump Therapy for A1C Reduction (STAR 3) study (1).
For instance, the method is currently being applied to the Sensor-Augmented Pump Therapy for A1C Reduction (STAR) 3 data of type 1 diabetic subjects wearing a sensor-augmented insulin pump (22).
A similar SH rate was found in the Sensor-Augmented Pump Therapy for A1c Reduction (STAR) 3 trial (∼13 events per 100 person-years in both the CGM group and control group) (14).
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