Spots Global Cancer Trial Database for HCL Single Arm Pilot Study in Treatment of Hyperglycemia of Pediatric ALL

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Trial Identification

Brief Title: HCL Single Arm Pilot Study in Treatment of Hyperglycemia of Pediatric ALL

Official Title: Safety and Feasibility Study of a Hybrid Closed-loop Insulin Delivery System for Children and Young Adults With High Risk Acute Lymphoblastic Leukemia

Study ID: NCT05006040

Conditions

High Risk Acute Lymphoblastic Leukemia

Interventions

Hybrid Closed Loop System

Study Description

Brief Summary: The overall objective of this pilot study is to determine the safety and feasibility of a hybrid closed-loop insulin delivery system for children and young adults with high risk acute lymphoblastic leukemia, during the induction chemotherapy phase while they are exposed to steroids and asparaginase that cause hyperglycemia.

Detailed Description: The overall objective of this pilot study is to determine the safety and feasibility of a hybrid closed-loop insulin delivery system for children and young adults with high risk acute lymphoblastic leukemia, during the induction chemotherapy phase while they are exposed to steroids and asparaginase that cause hyperglycemia. Insulin therapy would be beneficial in reducing hyperglycemia-associated complications in this period and thereby could improve other outcomes. The primary objective of the current pilot proposal is to demonstrate that hybrid closed loop pump therapy is a safe to be used in children and young adults with high risk acute lymphoblastic leukemia. If successful, the results of this study will be used to plan and support a larger, multi-center clinical trial and a grant proposal.