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.
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.
Authors: Sue A Brown; Boris P Kovatchev; Dan Raghinaru; John W Lum; Bruce A Buckingham; Yogish C Kudva; Lori M Laffel; Carol J Levy; Jordan E Pinsker; R Paul Wadwa; Eyal Dassau; Francis J Doyle; Stacey M Anderson; Mei Mei Church; Vikash Dadlani; Laya Ekhlaspour; Gregory P Forlenza; Elvira Isganaitis; David W Lam; Craig Kollman; Roy W Beck Journal: N Engl J Med Date: 2019-10-16 Impact factor: 91.245
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Authors: Laurel H Messer; Cari Berget; Tim Vigers; Laura Pyle; Cristy Geno; R Paul Wadwa; Kimberly A Driscoll; Gregory P Forlenza Journal: Pediatr Diabetes Date: 2020-01-03 Impact factor: 4.866
Authors: Marc D Breton; Lauren G Kanapka; Roy W Beck; Laya Ekhlaspour; Gregory P Forlenza; Eda Cengiz; Melissa Schoelwer; Katrina J Ruedy; Emily Jost; Lori Carria; Emma Emory; Liana J Hsu; Mary Oliveri; Craig C Kollman; Betsy B Dokken; Stuart A Weinzimer; Mark D DeBoer; Bruce A Buckingham; Daniel Cherñavvsky; R Paul Wadwa Journal: N Engl J Med Date: 2020-08-27 Impact factor: 91.245
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Authors: Gregory P Forlenza; Orit Pinhas-Hamiel; David R Liljenquist; Dorothy I Shulman; Timothy S Bailey; Bruce W Bode; Michael A Wood; Bruce A Buckingham; Kevin B Kaiserman; John Shin; Suiying Huang; Scott W Lee; Francine R Kaufman Journal: Diabetes Technol Ther Date: 2018-12-26 Impact factor: 6.118
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Authors: Erin C Cobry; Lauren G Kanapka; Eda Cengiz; Lori Carria; Laya Ekhlaspour; Bruce A Buckingham; Korey K Hood; Liana J Hsu; Laurel H Messer; Melissa J Schoelwer; Emma Emory; Katrina J Ruedy; Roy W Beck; Raj Paul Wadwa; Linda Gonder-Frederick Journal: Diabetes Technol Ther Date: 2021-01-28 Impact factor: 7.337
Authors: Melissa J Schoelwer; Lauren G Kanapka; R Paul Wadwa; Marc D Breton; Katrina J Ruedy; Laya Ekhlaspour; Gregory P Forlenza; Erin C Cobry; Laurel H Messer; Eda Cengiz; Emily Jost; Lori Carria; Emma Emory; Liana J Hsu; Stuart A Weinzimer; Bruce A Buckingham; Rayhan A Lal; Mary Clancy Oliveri; Craig C Kollman; Betsy B Dokken; Daniel R Cherñavvsky; Roy W Beck; Mark D DeBoer Journal: Diabetes Technol Ther Date: 2021-03-09 Impact factor: 7.337