Introduction & Objective: Adolescents and young adults (AYA) with acute lymphoblastic leukemia (ALL) are at risk of iatrogenic hyperglycemia during induction chemotherapy due to exposure to high dose corticosteroids and asparaginase, two cornerstones of ALL therapy. While hyperglycemia has been associated with adverse clinical outcomes, it is often underrecognized and undertreated. We evaluated the use of a hybrid closed-loop (HCL) insulin delivery system in this novel population at risk for severe hyperglycemia.
Methods: In this prospective trial, participants with newly diagnosed high-risk ALL received treatment with the Tandem t:slim X2 insulin pump with Control-IQ technology and Dexcom G6 continuous glucose monitor (CGM) during the 5-week chemotherapy induction period. The primary outcome was safety of HCL insulin delivery, as measured by hypoglycemia and adverse device events. Insulin usage and time in range (TIR) were also measured.
Results: A total of 5 participants, aged 13-18 years with no history of diabetes, received treatment with HCL insulin delivery. All participants started the system within 2 days after initiation of chemotherapy with high dose corticosteroids and prior to administration of asparaginase. Participants wore the system for a mean of 21 days and CGM for a mean of 23 days. The mean total daily insulin dose was 34.2 ± 24.9 units/day. Mean TIR was 84 ± 13% while on HCL, and mean time below range (TBR) was 0.9% ± 1.2%. One adverse event was related to bleeding at the CGM insertion site, and there were no severe hypoglycemic events.
Conclusion: The use of an HCL insulin delivery system for AYA patients with newly diagnosed ALL during induction chemotherapy met all feasibility and safety goals during this pilot trial. Rapid changes in insulin resistance caused by chemotherapy agents require close monitoring and prompt adjustments in HCL settings in this novel population.
E. Jost: Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc. S. Cho: None. S. Lange: None. C. Berget: Speaker's Bureau; Dexcom, Inc., Insulet Corporation, embecta. J.E. Pinsker: Employee; Tandem Diabetes Care, Inc. L. Hartman: None. G.P. Forlenza: Research Support; Abbott, Dexcom, Inc. Consultant; Dexcom, Inc. Research Support; Insulet Corporation. Consultant; Insulet Corporation. Research Support; Medtronic. Advisory Panel; Medtronic. Research Support; Tandem Diabetes Care, Inc. Consultant; Tandem Diabetes Care, Inc.
Tandem Diabetes and Dexcom Inc.
