This clinical trial evaluates whether a new hybrid closed-loop insulin delivery system can safely be used to treat blood sugar problems in patients being treated for high-risk acute lymphoblastic leukemia (ALL). Patients who are being treated for ALL have an increased risk of problems with their blood sugar due to side effects of chemotherapy, and increased blood sugar may cause more complications, such as infection. High blood sugar (hyperglycemia) is often untreated or under-treated due to concerns of complications of insulin therapy. The Tandem Control-IQ Professional Hybrid Closed Loop artificial pancreas system is a new method of glucose control that automatically modulates insulin delivery to minimize both low and high blood sugar through continuous glucose monitoring and insulin delivery via a pump. Using a hybrid closed-loop insulin delivery system may help manage blood sugar levels and reduce chemotherapy complications in patients with ALL undergoing chemotherapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05006040.
PRIMARY OBJECTIVES:
I. To examine the safety of hybrid closed-loop (HCL) insulin delivery in children and young adults with acute lymphoblastic leukemia during the induction chemotherapy phase as assessed by hypoglycemia exposure (blood glucose < 70 mg/dL), and rates of bleeding and infection at the insulin infusion and continuous glucose monitoring (CGM) site.
II. To evaluate the efficacy of glycemic control with HCL insulin delivery as assessed by time in range (TIR) and mean sensor glucose level.
III. To investigate the effect size of relationships between glycemic control and clinical outcomes such as rate of infection, length of hospitalization, length of pediatric intensive care unit (PICU) admission, rate of remission at the of induction, and need for readmission compared to a historical control.
OUTLINE:
Patients wear the Tandem Control-IQ Professional Hybrid Closed Loop artificial pancreas system for the duration of their standard of care induction chemotherapy.
After completion of study treatment, patients are followed up for 2 years.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUCHealth University of Colorado Hospital
Principal InvestigatorGregory Forlenza