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- Title
774-P: Fully Integrated Medical and Psychological Intervention for T1D Self-Management in Adolescents: Trial Design and Baseline Characteristics.
- Authors
ODONNELL, HOLLY; ALONSO, GUY T.; GOMER, TARA; MAJIDI, SHIDEH; SNELL-BERGEON, JANET K.; REZNICK-LIPINA, TYLER; WADWA, R. PAUL; DRISCOLL, KIMBERLY A.
- Abstract
There is an urgent need to address medical and psychosocial needs of adolescents with T1D. Baseline sample characteristics and study progress data are presented from a combined in-person/telehealth RCT using multiphasic optimization strategy (2x2 factorial design) to improve A1C in 10-17 yr olds (≥1 A1C 9-12% in prior yr). During Phase 1, 88 adolescents (target N=100) with T1D (Mage=14.5 yrs; 50% female; 79.5% White, 10.2% Hispanic; 76.1% insulin pump) were randomized to Enhanced Standard Care (Medical visit only every 6 weeks) or Integrated Medical/Psychology (Enhanced Standard Care+Personalized Adherence Feedback Report). During Phase 2 (6-mo visit; N completed=75) all adolescents are re-randomized to another 6 months of intervention every 6 weeks: Enhanced Standard Care or Integrated Medical/Psychology (Enhanced Standard Care+Problem-Solving). During Phase 3 (12-mo visit; N complete=50), psychology support is withdrawn; participants are randomized to Enhanced Standard Care (Medical visit only every 6 weeks) or Standard Care (Medical visit only every 3 months) for 6 months). Adolescents and caregivers download devices and complete psychosocial questionnaires at visits (Table; no statistically significant group differences). N=25 completed the study (18-month visit) and 5 withdrew (94% retention to date); data collection is ongoing. Disclosure: H. ODonnell: None. G.T. Alonso: None. T. Gomer: None. S. Majidi: Advisory Panel; Self; Companion Medical. J.K. Snell-Bergeon: Stock/Shareholder; Self; GlaxoSmithKline plc. T. Reznick-Lipina: None. R. Wadwa: Advisory Panel; Self; Eli Lilly and Company, Medtronic. Research Support; Self; Dexcom, Inc., Eli Lilly and Company, MannKind Corporation, Medtronic, Novo Nordisk Inc., Tandem Diabetes Care. K.A. Driscoll: None. Funding: National Institute of Diabetes and Digestive and Kidney Diseases (DP3DK113363)
- Publication
Diabetes, 2020, Vol 69, pN.PAG
- ISSN
0012-1797
- Publication type
Article
- DOI
10.2337/db20-774-P