899-P: Patient Reported Outcomes (PROs) for Young Children Using the Control IQ Hybrid Closed-Loop System (CIQ)
Authors: SCHNEIDER-UTAKA AIKA , REED ZACHARIAH , BUCKINGHAM BRUCE A. , COBRY ERIN C. , DEBOER MARK D. , EKHLASPOUR LAYA , SCHOELWER MELISSA , PAUL WADWA R. , LUM JOHN W. , KOLLMAN CRAIG , BECK ROY , BRETON MARC D. , HOOD KOREY K. , TRIAL STUDY GROUP PEDAP 
Published: June 2023

The objective was to examine PROs after use of t:slim X2 insulin pump with Control-IQ technology (CIQ) in young children. Children with T1D ages 2-&lt;6 years (n=102) were randomized 2:1 to either CIQ or standard care (SC) with pump or MDI plus CGM for 13 wks. Both groups could use CIQ for an additional 13 wks. Parents completed PROs at baseline, 13-, and 26-wks examining hypoglycemia concerns, quality of life, parenting stress, and sleep (see table). At 26 wks, 28 families participated in focus groups about their experiences with CIQ. Repeated measures analysis with False Discovery Rate correction and accounting for baseline showed that all 5 PROs surveys moved in the positive direction. Four showed that CIQ was superior to SC at 26 wks (p values &lt; 0.05). Focus group findings showed optimized glycemic control overall and nighttime control specifically (28 of 28 families endorsed). All but 2 families noted substantial reduction in management burden resulting in less mental burden and all but 4 stated that they wanted their kids to continue using CIQ. Families utilizing CIQ experienced glycemic benefit coupled with substantial benefit in PROs, documented on surveys and focus groups. Families utilizing CIQ had reduced hypoglycemia concerns and parenting stress, and improved quality of life and sleep. These findings demonstrate benefit of CIQ in young children with T1D that goes beyond documented glycemic benefit.

Disclosure
A.Schneider-utaka: None. 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. K.K.Hood: Consultant; Cecelia Health. 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. E.C.Cobry: None. 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. M.Schoelwer: Research Support; Tandem Diabetes Care, Inc., Insulet Corporation. 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. J.W.Lum: None.

Funding
National Institute of Diabetes and Digestive and Kidney Diseases (U01DK127551); Tandem Diabetes Care, Inc.; Dexcom, Inc.