1881-P: CamAPS FX HCL System Improves HbA1c and Tir in T1DM Patients with Poorly Controlled Diabetes and Mental Health Challenges (HI-LOOP Study)

Introduction and Objective: The HiLoop Study aimed to assess whether the CamAPS FX system improves glycaemic control, quality of life, and emotional functioning in adults with T1DM, elevated HbA1c, and mental health challenges. Methods: A three-centre, randomized, open-label controlled trial was conducted in patients aged 18-65 years with HbA1c≥9.0% and mental health challenges, including diabetes distress, diabetes burnout, fear of hypoglycemia, depression, and neurotic symptoms. Patients were randomized to either the intervention group using the CamAPS FX app or the control group continuing their previous therapy regimen. The primary glycaemic outcome was the change in HbA1c, and the main secondary glycaemic outcomes were the change in mean glucose, TIR and TBR between groups after 3 months. Results: Thirty subjects (average age 32.7±12.8 years, T1DM duration 13.3±8.5 years) were included in the analysis, with 15 in the intervention group and 15 in the control group. Baseline HbA1c, mean glucose and TIR were 10.3±0.9%, 10.7±1.6%, 248±57 mg/dL, 223±51 mg/dL, and 28.3±17.6% and 30.8±20.6% in the CamAPS FX and control group, respectively. HbA1c changed of -2.5±1.4% vs. -0.9±1.0%, mean glucose of -66±68 mg/dL vs. 15±31 mg/dL and TIR of 29.3±23.0% vs. -3.1±9.6%, in the intervention vs. control group, respectively; with between therapy mean adjusted differences of HbA1c of -1.7% (95% CI: −2.6; −0.8), mean glucose of -67 mg/dL (95% CI: -100; -34) and TIR of 28.8% (95% CI: 16.8; 40.9). There was no significant change in time below range (TB70 1.3 % (95% CI: -0.3; 2.9); TB54 0.2% (95% CI: -1.0; 1.3)). Conclusion: CamAPS FX HCL system significantly lowers HbA1c and increases TIR in T1DM with poorly controlled diabetes and mental health challenges compared to standard therapy. In such patients, HCL should be considered as the therapy of choice to improve glycemic control. Disclosure J. Hohendorff: Speaker's Bureau; Ended; Dexcom, Inc. Research Support; Current; Ypsomed AG. K. Cyranka: None. M.P. Wróbel: None. A. Grzelka-Wozniak: Other - Speaker; Ended; Novo Nordisk, Eli Lilly and Company, AstraZeneca, Roche Diabetes Care, Boehringer Ingelheim International GmbH. M. Plonka-Stepien: None. B. Matejko: Speaker's Bureau; Ended; Abbott. Speaker's Bureau; Current; Medtronic. Speaker's Bureau; Ended; Dexcom, Inc., Ascensia Diabetes Care. M. Adamczyk-Hohendorff: None. D.C. Rokicka: None. D. Zozulinska-Ziólkiewicz: Advisory Panel; Current; Abbott Diabetes. Speaker's Bureau; Current; Abbott Diabetes, Eli Lilly and Company, Novo Nordisk, Sanofi, Dexcom, Inc. Advisory Panel; Current; Medtronic. Speaker's Bureau; Current; Medtronic, Servier Laboratories. M. Malecki: Consultant; Current; Abbott. Speaker's Bureau; Current; Dexcom, Inc. Research Support; Current; Ypsomed AG. Speaker's Bureau; Current; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk A/S. Advisory Panel; Current; Lilly. Speaker's Bureau; Current; Sanofi. Research Support; Current; Medtronic. Speaker's Bureau; Current; Servier Laboratories. T. Klupa: Speaker's Bureau; Current; Abbott Diabetes, Eli Lilly and Company, Boehringer Ingelheim International GmbH, Dexcom, Inc., Novo Nordisk. Research Support; Current; Medtronic. Advisory Panel; Current; Sanofi. Speaker's Bureau; Current; KRKA, Servier Laboratories, AstraZeneca.