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Extended Use of the Control-IQ Closed-Loop Control System in Children With Type 1 Diabetes
Lauren G Kanapka1, R Paul Wadwa2, Marc D Breton3
1Jaeb Center for Health Research, Tampa, FL.
Insights
The Control-IQ closed-loop control system safely improves glycemic control in children with type 1 diabetes. Improvements in time in range were observed from the first day of use and sustained for up to 28 weeks.
Area of Science:
- Pediatric Endocrinology
- Diabetes Technology
- Metabolic Diseases
Background:
- Type 1 diabetes management in children requires continuous monitoring and intervention.
- Closed-loop control (CLC) systems offer automated insulin delivery adjustments.
- Previous studies indicated potential benefits of CLC systems in pediatric populations.
Purpose of the Study:
- To further evaluate the safety and efficacy of the Control-IQ CLC system in children with type 1 diabetes.
- To assess the long-term glycemic control improvements with CLC therapy.
- To compare CLC performance against sensor-augmented pump (SAP) therapy.
Main Methods:
- A 16-week randomized clinical trial (RCT) compared CLC with SAP therapy in 101 children (6-13 years) with type 1 diabetes.
- Participants transitioned between therapies, forming SAP-CLC and CLC-CLC cohorts for subsequent evaluation.
- Glycemic control metrics, including time in range (TIR) and time below range, were analyzed over 12 weeks post-RCT.
Main Results:
- In the SAP-CLC cohort, mean TIR increased from 55% to 65% with CLC (P < 0.001).
- 36% of participants achieved TIR >70% with CLC, compared to 14% with SAP (P = 0.03).
- Significant improvements in TIR and reductions in time below 70 mg/dL were observed rapidly, with no severe hypoglycemia or DKA.
Conclusions:
- The Control-IQ CLC system safely enhances glycemic control in children with type 1 diabetes.
- Improvements in glycemic control are evident from the first day of CLC use.
- Sustained glycemic control benefits were demonstrated through 28 weeks of CLC system utilization.
Objective:
To further evaluate the safety and efficacy of the Control-IQ closed-loop control (CLC) system in children with type 1 diabetes.
Research Design And Methods:
After a 16-week randomized clinical trial (RCT) comparing CLC with sensor-augmented pump (SAP) therapy in 101 children 6-13 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 1st 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% prerandomization to 67 ± 10% during the RCT and remained reasonably stable at 66 ± 10% through the 12 weeks post-RCT. No episodes of diabetic ketoacidosis or severe hypoglycemia occurred 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 6-13 years old with type 1 diabetes from the 1st day of use and demonstrates that these improvements can be sustained through 28 weeks of use.
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