<b>Objective: </b>To further
evaluate the safety and efficacy of the Control-IQ closed loop control (CLC)
system in children with type 1 diabetes.<b></b>
<p><b>Research Design and Methods: </b>Following
a 16-week randomized clinical trial (RCT) comparing CLC with sensor augmented pump (SAP)
therapy in 101 children age 6 to 13 years old with type 1 diabetes, 22 participants in the SAP group initiated use of the CLC system
(referred to as SAP-CLC cohort), and 78 participants in the CLC group continued
use of CLC (CLC-CLC cohort) for 12 weeks.
</p>
<p><b>Results: </b>In the SAP-CLC cohort, mean percentage of time in range 70-180
mg/dL (TIR) increased from 55±13% using SAP during the RCT to 65±10% using CLC (P<0.001),
with 36% of the cohort achieving TIR >70% plus time <54 mg/dL <1%
compared with 14% when using
SAP (P=0.03). Substantial
improvement in TIR was seen after the first day of CLC. Time <70
mg/dL decreased from 1.80% to 1.34% (P<0.001). In the CLC-CLC cohort, mean TIR
increased from 53±17% pre-randomization to 67±10% during the RCT and remained reasonably
stable at 66±10% through the 12-weeks post-RCT. There were no episodes of
diabetic ketoacidosis or severe hypoglycemia in either cohort.</p>
<p><b>Conclusions: </b> This further evaluation of the Control-IQ CLC
system supports the findings of the preceding RCT that use of a closed-loop
system can safely improve glycemic control in children 6 to 13 years old with
type 1 diabetes from the first day of use and demonstrates that these
improvements can be sustained through 28 weeks of use. </p>