Extended Use of the Control-IQ Closed-Loop Control System in Children With Type 1 Diabetes
Research Design and Methods: 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.
Results: 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.
Conclusions: 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.