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Abstract ContextYouth with type 1 diabetes (T1D) struggle to meet and sustain hemoglobin A1c (HbA1c) targets. Youth enrolled in the Pilot 4T Study improved HbA1c by 0.5% at 1 year, compared to historical controls. ObjectiveTo assess 3 years of glycemic outcomes in the Pilot 4T Study. MethodsThe Pilot 4T Extension cohort was prospectively followed to determine changes in HbA1c and continuous glucose monitoring (CGM) metrics over 3 years at the Stanford Medicine Children's Health Diabetes Clinic. Youth with T1D in the Pilot 4T Study enrolled in the extension phase started CGM in the first month of diabetes diagnosis, received intensified education and remote patient monitoring (RPM) weekly for the first year of diabetes diagnosis, and monthly RPM in the extension phase. HbA1c and CGM metrics were evaluated over the first 3 years of diagnosis. ResultsIn the Pilot 4T cohort, 78.5% (n = 102) of participants enrolled in the study extension phase and were followed through 3 years. The adjusted difference in HbA1c at 3 years was 1.2% (95% CI 0.7%-1.7%) lower in the Pilot 4T cohort than in the Historical cohort. In the Pilot 4T cohort, 68% and 37% met the <7.5% and <7% HbA1c targets at 3 years, respectively, compared to 37% and 20% in the Historical cohort. ConclusionYouth with T1D in the Pilot 4T extension phase sustained improvements in HbA1c over 3 years. Focusing resources on intensive management during the first year after T1D diagnosis may impact long-term glycemia. 

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. 

Continuous glucose monitoring (CGM) use soon after T1D diagnosis in the 4T Study was associated with improved glycemic outcomes. We evaluated participant factors associated with elevated versus in target A1c for youth in the 4T Study. All youth from the 4T Study 1 (n=133) were evaluated. In this analysis, the 110 youth who had a final A1c between 6-13 months were included in a complete case analysis. These 110 youth were comparable to the 133 4T Study 1 youth by race/ethnicity, insurance, preferred language, and age. Group differences by non-ordered A1c categories were evaluated for categorical (race/ethnicity, insurance, gender, and language) and continuous (age and time from CGM start) variables via chi-square and ANOVA, respectively. A majority of youth in the 4T Study 1 met glycemic targets (65% with A1c ≤7% between 6-13 months post-diagnosis). Age, race/ethnicity, and insurance status were significantly associated with A1c categories (p=0.02 for all; Table). Higher A1c categories were more likely to include Hispanic youth and youth with public insurance. In the 4T Study 1, Hispanic youth and youth with public insurance had higher A1c categories despite similar CGM access and training. These findings suggest the need to address additional drivers of disparities in addition to CGM access. Approaches focused on health equity are required to improve glycemic outcomes in all youth newly diagnosed with T1D. Disclosure J. Kim: 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. F. K. Bishop: None. D. Scheinker: None. R. Johari: None. M. Desai: None. K. K. Hood: Consultant; Cecelia Health. D. M. Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc. A. Addala: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (K23DK13134201, R18DK122422) 

Methods to optimize care after T1D diagnosis are needed. We hypothesized lowering A1c targets to <7% would further lower A1c in the 4T Study in which CGM with asynchronous remote patient monitoring (RPM) is initiated after T1D diagnosis. All youth with newly diagnosed T1D (June 2020-March 2022) were offered CGM and RPM after diagnosis (Study 1, n=133). We compared A1c at 1-year in Study 1 with the 4T Pilot (2018-20) and Historical cohorts (2014-16). We visualized population-based A1c trajectories using locally estimated scatter plot smoothing (Fig) and % meeting A1c targets. Mean A1c at diagnosis was similar in Pilot (12.2%±2.1%) and Study 1 (12.2±2.4%) and higher than the Historical cohort (10.7±2.5%). In Study 1, the median age of diagnosis was 10.8 years, 55% male, 40% non-Hispanic White, and 38% with public insurance. CGM initiation occurred within 30 days of diagnosis in 98.5%. At 3, 6, 9, and 12 months post-diagnosis, the Study 1 cohort had LOESS-based mean A1c differences of 0.16%, 0.24%, 0.31%, and 0.58% lower than the Pilot and 0.04%, 0.60%, 0.83%, and 1.06% lower than the Historical cohort. A1c target <7% was met by 61% of youth in Study 1, 51% in the Pilot and 28% in the Historical cohort. Time <70mg/dl was ≤2.3%. The 4T program which emphasizes early CGM initiation, RPM, tighter glucose targets, and consistent team messaging was associated with lower A1c. These data support implementation of the 4T program in youth with T1D. Disclosure P.Prahalad: None. D.M.Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc. 4t study group: n/a. V.Ding: 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. A.Addala: None. F.K.Bishop: None. D.Scheinker: None. R.Johari: None. M.Desai: None. K.K.Hood: Consultant; Cecelia Health. Funding National Institutes of Health (P30DK116074), (R18DK122422 to D.M.M.); Dexcom, Inc.; Lucile Packard Children’s Hospital Auxiliaries Endowment; Stanford Maternal and Child Health Research Institute 

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) 

Importance Continuous glucose monitoring (CGM) is associated with improvements in hemoglobin A 1c (HbA 1c ) in youths with type 1 diabetes (T1D); however, youths from minoritized racial and ethnic groups and those with public insurance face greater barriers to CGM access. Early initiation of and access to CGM may reduce disparities in CGM uptake and improve diabetes outcomes. Objective To determine whether HbA 1c decreases differed by ethnicity and insurance status among a cohort of youths newly diagnosed with T1D and provided CGM. Design, Setting, and Participants This cohort study used data from the Teamwork, Targets, Technology, and Tight Control (4T) study, a clinical research program that aims to initiate CGM within 1 month of T1D diagnosis. All youths with new-onset T1D diagnosed between July 25, 2018, and June 15, 2020, at Stanford Children’s Hospital, a single-site, freestanding children’s hospital in California, were approached to enroll in the Pilot-4T study and were followed for 12 months. Data analysis was performed and completed on June 3, 2022. Exposures All eligible participants were offered CGM within 1 month of diabetes diagnosis. Main Outcomes and Measures To assess HbA 1c change over the study period, analyses were stratified by ethnicity (Hispanic vs non-Hispanic) or insurance status (public vs private) to compare the Pilot-4T cohort with a historical cohort of 272 youths diagnosed with T1D between June 1, 2014, and December 28, 2016. Results The Pilot-4T cohort comprised 135 youths, with a median age of 9.7 years (IQR, 6.8-12.7 years) at diagnosis. There were 71 boys (52.6%) and 64 girls (47.4%). Based on self-report, participants’ race was categorized as Asian or Pacific Islander (19 [14.1%]), White (62 [45.9%]), or other race (39 [28.9%]); race was missing or not reported for 15 participants (11.1%). Participants also self-reported their ethnicity as Hispanic (29 [21.5%]) or non-Hispanic (92 [68.1%]). A total of 104 participants (77.0%) had private insurance and 31 (23.0%) had public insurance. Compared with the historical cohort, similar reductions in HbA 1c at 6, 9, and 12 months postdiagnosis were observed for Hispanic individuals (estimated difference, −0.26% [95% CI, −1.05% to 0.43%], −0.60% [−1.46% to 0.21%], and −0.15% [−1.48% to 0.80%]) and non-Hispanic individuals (estimated difference, −0.27% [95% CI, −0.62% to 0.10%], −0.50% [−0.81% to −0.11%], and −0.47% [−0.91% to 0.06%]) in the Pilot-4T cohort. Similar reductions in HbA 1c at 6, 9, and 12 months postdiagnosis were also observed for publicly insured individuals (estimated difference, −0.52% [95% CI, −1.22% to 0.15%], −0.38% [−1.26% to 0.33%], and −0.57% [−2.08% to 0.74%]) and privately insured individuals (estimated difference, −0.34% [95% CI, −0.67% to 0.03%], −0.57% [−0.85% to −0.26%], and −0.43% [−0.85% to 0.01%]) in the Pilot-4T cohort. Hispanic youths in the Pilot-4T cohort had higher HbA 1c at 6, 9, and 12 months postdiagnosis than non-Hispanic youths (estimated difference, 0.28% [95% CI, −0.46% to 0.86%], 0.63% [0.02% to 1.20%], and 1.39% [0.37% to 1.96%]), as did publicly insured youths compared with privately insured youths (estimated difference, 0.39% [95% CI, −0.23% to 0.99%], 0.95% [0.28% to 1.45%], and 1.16% [−0.09% to 2.13%]). Conclusions and Relevance The findings of this cohort study suggest that CGM initiation soon after diagnosis is associated with similar improvements in HbA 1c for Hispanic and non-Hispanic youths as well as for publicly and privately insured youths. These results further suggest that equitable access to CGM soon after T1D diagnosis may be a first step to improve HbA 1c for all youths but is unlikely to eliminate disparities entirely. Trial Registration ClinicalTrials.gov Identifier: NCT04336969