Background: The Medtronic 670G Hybrid Closed Loop (HCL) is completing pivotal trials in children with type 1 diabetes <7 years old. Little is known about how to support families and young children using HCL.
Methods: Participants ages 2-7 in the 670G pivotal trial extension phase participated in novel, ongoing, multicenter videoconferencing interventions to support HCL use. Families downloaded HCL every 2 weeks and were randomized to two support interventions or a minimum feedback (control arm) targeted to either failed adherence (<80% Auto Mode) or suboptimal glycemic control (time 70-180 mg/dl <70%) by Sequential Multiple Assignment Randomization Trial (SMART) design. Interventions included two audio/videoconferencing sessions in a 2-week period. Participants were evaluated and re-randomized every 2 weeks over 3 months. Paired t-tests were used to compare glycemic and quality-of-life outcomes.
Results: Child-parent dyads (n=23) were enrolled (mean child age 5.2 ± 1.5 years, 39% female, mean diabetes duration 34 months). Dyads received a total of 39 interventions. HbA1c, Time-in-Range, and Auto Mode use remained stable over 3 months, and diabetes distress and hypoglycemia fear and confidence improved significantly (Table). Data collection is ongoing.
Conclusion: Targeted interventions for caregivers of young children using HCL demonstrated quality-of-life improvements without deterioration in glycemic control or Auto Mode use.
L.H. Messer: Advisory Panel; Self; Capillary Biomedical, Inc. Consultant; Self; Clinical Sensors. S. Hanes: None. I. Tabatabai: None. L. DiMeglio: Research Support; Self; Amgen Inc., Caladrius Biosciences, Inc., Janssen Research & Development, Medtronic, Sanofi. Other Relationship; Self; Dexcom, Inc. T.S. Hannon: Advisory Panel; Self; Eli Lilly and Company. G.P. Forlenza: Advisory Panel; Self; Dexcom, Inc. Consultant; Self; Medtronic MiniMed, Inc., Tandem Diabetes Care. Research Support; Self; Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. S. Woerner: None. S. Lange: Other Relationship; Self; Medtronic MiniMed, Inc. K.A. Driscoll: None. K.K. Hood: Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc. Speaker's Bureau; Self; Johnson & Johnson Diabetes Institute. H. Rodriguez: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Daiichi Pharm Corp, MannKind Corporation, Medtronic MiniMed, Inc. Research Support; Spouse/Partner; Medtronic MiniMed, Inc. Research Support; Self; Takeda Pharmaceutical Company Limited. Other Relationship; Self; Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Novo Nordisk Inc., Profusa, Inc. Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Beta Bionics, ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. Other Relationship; Self; Insulet Corporation, Tandem Diabetes Care.
National Institute of Diabetes and Digestive and Kidney Diseases