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Abstract AimsPsychosocial impacts of early continuous glucose monitoring (CGM) initiation in youth soon after type 1 diabetes diagnosis are underexplored. We report parent/guardian and youth patient‐reported outcomes (PROs) that measure psychosocial states for families in 4T Study 1. Materials and MethodsOf the 133 families in the 4T Study 1, 132 parent/guardian and 66 youth (≥11 years) were eligible to complete PROs. PROs evaluated included diabetes distress, global health, diabetes technology attitudes and CGM benefits/burden scales. Temporal trends of PROs were assessed via generalised linear mixed effects regression. Sociodemographic and clinical characteristics associated with PROs were evaluated. Psychosocial associations were evaluated by regressing parental distress on youth distress. ResultsPRO completion rates were 85.6% and varied between parent/guardian and youth. Throughout the study, parent/guardian and youth distress remained low and youth had increased technology acceptance (p = 0.046). Each additional month of CGM use was associated with a 14% decrease in the odds of experiencing diabetes distress (aOR = 0.86, 95% CI [0.76, 0.99],p = 0.029). Additionally, higher time‐in‐range was associated with decreased diabetes distress (p = 0.048). Age, diabetic ketoacidosis at diagnosis, gender, ethnicity, insurance status and language spoken were not associated with PROs. ConclusionsInitiation of CGM shortly after type 1 diabetes diagnosis does not have unintended negative psychological consequences. Longer duration of CGM use was associated with decreased youth distress and technology acceptance increased throughout the study. 

Psychosocial impacts of early CGM initiation in youth soon after T1D diagnosis are underexplored. We report parent/guardian (PG) and youth trends in Patient Reported Outcomes (PROs) for families in the 4T Study 1. Of the 133 participants in the 4T Study 1, 125 PG and 60 youth (≥11 years) were eligible for PROs. PROs included Diabetes Distress Scale - Parent (mean DDS-P) for PG and for youth, Diabetes Distress Scale (DDS sum), PROMIS Pediatric Global Health (PGH sum), Diabetes Technology Attitudes (DTA sum), and CGM Benefits/Burden (BenCGM and BurCGM sum). Kruskal Wallis rank sum test evaluated temporal trends and sociodemographics were evaluated (Numerical: Wilcoxon rank; Categorical: Fisher's if n<5, Chi-squared if n≥5). PROs completion rates were higher for PG than youth at baseline (74% v 59%), 3 months (70% v 53%), and 6 months (66% v 50%). PG DDS-P remained low throughout the study (Table). Youth had favorable psychosocial trends (low DDS and high PGH), and perceived technology positively (high DTA and BenCGM with low BurCGM). Age, DKA at diagnosis, gender, ethnicity, insurance status, and language spoken were not associated with PROs scores in PG or youth. CGM initiation shortly after T1D diagnosis is not associated with poor or worsening PROs for PG and youth. These data suggest that early CGM initiation does not adversely impact psychosocial states for families and youth with T1D. Disclosure A.Addala: None. F.K.Bishop: None. D.P.Zaharieva: Advisory Panel; Dexcom, Inc., Research Support; Hemsley Charitable Trust, International Society for Pediatric and Adolescent Diabetes, Insulet Corporation, Speaker's Bureau; American Diabetes Association, Ascensia Diabetes Care, Medtronic. P.Prahalad: None. M.Desai: None. D.M.Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc. K.K.Hood: Consultant; Cecelia Health. V.Ritter: None. B.Shaw: None. E.Pang: None. A.L.Cortes-navarro: None. I.Balistreri: None. A.Loyola: None. S.A.Alamarie: None. A.Schneider-utaka: None. Funding National Institutes of Health (K23DK13134201, R18DK122422) 

The 4T Study 1 is a clinical pragmatic research trial that starts continuous glucose monitoring (CGM) within 30 days of T1D diagnosis and monitors PROs. We report the longitudinal relationship of PROs between newly diagnosed youth and parents/guardians (PG). PROs surveys were administered to youth and PG at baseline, 3, and 6 months. PG PROs included the 20-item parent Diabetes Distress Scale (DDS-P) and youth PROs were the 2-item Diabetes Distress Scale (DDS-2) and the 7-item PROMIS Pediatric Global Health Scale (PGH-7). Pearson correlations evaluated the relationship between scores on the PG and youth PROs. Youth (n=60 who were aged ≥11 years) with new onset T1D and their PG (n=125) were eligible to complete PROs, yet response rates varied (at baseline, 3-, 6-months: Youth 59%, 53%, and 50% vs PG 74%, 70%, and 66%). Correlations showed that PG diabetes distress was positively correlated with child diabetes distress at baseline (r=0.48, p=0.003) and at 3 months (r= 0.35, p=0.058). However, by 6 months, this association decreased in strength and significance (r=0.16, p=0.42). Youth global health was inversely correlated with PG diabetes distress at baseline (r=-0.36, p=0.029) and 3 months (r=-0.53, p=0.002) and this correlation was not significant at 6 months (r =-0.049, p=0.81). These data suggest that the relationship between PG diabetes distress and youth psychosocial states are dynamic. PG and youth psychosocial states are strongly associated after diagnosis and decrease over time. Utilization of CGM, age, T1D duration, response rate, and changes in the PG-youth relationship (such as decreased adult involvement or increased independence of youth) may contribute to our findings. Further investigation of longitudinal relationships between PG and youth PROs may provide additional insight into PG and youth psychosocial states and diabetes outcomes and indicate optimal timing for assessment and treatment referral. Disclosure S.A.Alamarie: None. F.K.Bishop: None. D.P.Zaharieva: Advisory Panel; Dexcom, Inc., Research Support; Hemsley Charitable Trust, International Society for Pediatric and Adolescent Diabetes, Insulet Corporation, Speaker's Bureau; American Diabetes Association, Ascensia Diabetes Care, Medtronic. P.Prahalad: None. M.Desai: None. D.M.Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc. K.K.Hood: Consultant; Cecelia Health. A.Addala: None. E.Pang: None. A.L.Cortes-navarro: None. N.Arrizon-ruiz: None. I.Balistreri: None. A.Loyola: None. A.Schneider-utaka: None. V.Ritter: None. B.Shaw: None. Funding National Institutes of Health (R18DK122422) 

Psychosocial states significantly impact T1D care and management for youth and their families. As part of a clinical pragmatic study, we report the number of elevated Patient Reported Outcomes (PROs) in newly diagnosed families and track their progress to psychological care. Parents/guardians (PG, n=125/133 4T Study 1 participants) and youth ≥11 years (n=60) were eligible to complete baseline, 3-, and 6-month PROs. PG completed Diabetes Distress Scale - Parent (DDS-P) and youth completed Diabetes Distress Scale (DDS-2) and PROMIS Pediatric Global Health Scale (PGH). Elevated PROs were based on published guidelines and were referred to the clinic's psychological services. Survey completeness was verified by staff to identify false flags. Staff reapproached the participant's psychologist for re-flagged PROs >3 months after the last visit. Over the three study time periods, a total of 99 PROs flags were evaluated (Table). At baseline, there were 32% flagged PROs, which decreased to 27% and 23% at 3 and 6 months, respectively. Elevated DDS-P was the most common reason for referral (75%). Early psychological intervention may explain the reduction in elevated PROs over the study period. With the implementation of systematic PROs in this new onset population, we observed it was common to have diabetes distress and families were receptive to psychological services. Disclosure A.Schneider-utaka: None. F.K.Bishop: None. D.P.Zaharieva: Advisory Panel; Dexcom, Inc., Research Support; Hemsley Charitable Trust, International Society for Pediatric and Adolescent Diabetes, Insulet Corporation, Speaker's Bureau; American Diabetes Association, Ascensia Diabetes Care, Medtronic. P.Prahalad: None. M.Desai: None. D.M.Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc. K.K.Hood: Consultant; Cecelia Health. A.Addala: None. E.Pang: None. A.L.Cortes-navarro: None. I.Balistreri: None. A.Loyola: None. N.Arrizon-ruiz: None. S.A.Alamarie: None. V.Ritter: None. B.Shaw: None. Funding National Institutes of Health (R18DK122422)