T1D management in children < age 6 yrs is challenging due to unpredictable food intake and activity. Efficacy of AID with the Tandem t:slim X2 insulin pump with Control-IQ technology (CIQ) in this age group has not been well studied. Data included 95 children with T1D age 2 to < 6 yrs (age 3.9±1.2 yrs, 46% male, 75 % non-Hispanic white, 34% on multiple daily injections) enrolled in a 13-week extended use phase of a randomized trial of closed loop control (CLC) with CIQ. In this phase, the group assigned to CLC for the initial 13 weeks continued on CLC (CLC-CLC) and those initially using standard care (SC) were placed on CLC (SC-CLC). CGM time in range 70-180 mg/dL (TIR) was the primary outcome. The SC-CLC group (n=33) increased TIR using CLC in the extension compared to the SC period (68±9% vs. 56±13%, p<0.001) with no significant change in hypoglycemia (%CGM < 54 mg/dL 0.4±0.3% vs. 0.5±0.6%, p=0.03). TIR increased within the first week of CLC use similar to the first 13 weeks of AID use for the CLC-CLC group (Figure). CLC training was completed virtually for 82% of the SC-CLC group. The CLC-CLC group (n=62) maintained TIR (71±11% vs. 70±10%, p=0.80) with slightly lower rates of hypoglycemia (%CGM < 54 mg/dL 0.5±0.4% vs. 0.6±0.5%, p=0.08). In conclusion, these data show that in young children age 2 to < 6, CLC with Control-IQ technology leads to increased TIR without an increase in time in hypoglycemia. Disclosure R.Wadwa: Consultant; Eli Lilly and Company, Other Relationship; Dexcom, Inc., Eli Lilly and Company, Research Support; Dexcom, Inc., Eli Lilly and Company, Beta Bionics, Inc., Tandem Diabetes Care, Inc. C.Kollman: Research Support; Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc. R.Beck: Consultant; Eli Lilly and Company, Novo Nordisk, Diasome, Insulet Corporation, Research Support; Tandem Diabetes Care, Inc., Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc., Medtronic, Ascensia Diabetes Care, Roche Diabetes Care, Eli Lilly and Company, Novo Nordisk. M.D.Breton: Consultant; Dexcom, Inc., Tandem Diabetes Care, Inc., Roche Diabetes Care, Sanofi, Arecor, Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc., Novo Nordisk. Pedap trial study group: n/a. Z.Reed: None. B.A.Buckingham: Advisory Panel; Medtronic, Novo Nordisk, Consultant; Lilly, Research Support; Medtronic, Insulet Corporation, Tandem Diabetes Care, Inc. M.D.Deboer: Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc. L.Ekhlaspour: Consultant; Ypsomed AG, Tandem Diabetes Care, Inc., Other Relationship; NIH - National Institutes of Health, Research Support; MannKind Corporation, Tandem Diabetes Care, Inc., JDRF, Speaker's Bureau; Insulet Corporation. E.C.Cobry: None. M.Schoelwer: Research Support; Tandem Diabetes Care, Inc., Insulet Corporation. C.Berget: Consultant; Insulet Corporation, Dexcom, Inc., Other Relationship; Tandem Diabetes Care, Inc. J.W.Lum: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (U01DK127551); Tandem Diabetes Care, Inc.; Dexcom, Inc.
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