Clinical trial NCT05006040: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: High Risk Acute Lymphoblastic Leukemia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
name: DexCom, Inc.
name: Tandem Diabetes Care, Inc.
name: National Cancer Institute (NCI)
First posted: 2021-08-16
Enrollment: 1
Sex: ALL
Minimum age (years): 10
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a non-randomized prospective cohort study about the safety and feasibility of a commercially available hybrid closed loop insulin delivery system in children and young adults with high-risk ALL who are at high risk of hyperglycemia due to an intensive chemotherapy regimen containing steroids and asparaginase
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Patients ages 10 years old and above
2. Patients who are newly diagnosed with high-risk acute lymphoblastic leukemia
3. Patients who have started or will start an induction chemotherapy regimen containing steroid and asparaginase
4. Patients (if over 18 years of age) or parent/guardian (if the patient is under 18 years of age) must be fluent in reading and speaking English
5. Parent or guardian living in the home with the participant who also receives training on diabetes, CGM, HCL therapy, and the safety protocols

Exclusion Criteria:

1. Preexisting diabetes
2. Severe psychiatric disease or developmental delays, that might interfere with ability to provide informed consent
3. Active skin condition that would affect sensor placement
4. Any other medical condition which in the opinion of the investigators impairs the person's ability to safely participate in the trial, including but limited to:

   1. Significant chronic kidney disease (eGFR \<60) or requiring hemodialysis
   2. Significant liver disease
   3. History of adrenal insufficiency
   4. History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
   5. History of thyroid cancer
5. Use of intravenous or oral acetaminophen more than 60 mg/kg/day (maximum 4000 mg/day)

Primary outcomes:
measure: CGM Time in hypoglycemia (blood glucose < 70 mg/dL)
timeFrame: 35 days
measure: Number of episodes of symptomatic hypoglycemia
timeFrame: 35 days
measure: Rate of infection at the CGM insertion site
timeFrame: 35 days
measure: Rate of bleeding at the CGM insertion site
timeFrame: 35 days
measure: Rate of infection at the HCL insulin infusion site
timeFrame: 35 days
measure: Rate of bleeding at the HCL insulin infusion site
timeFrame: 35 days
Secondary outcomes:
measure: Efficacy of glycemic control with HCL insulin delivery assessed by Time in Ranges (TIR)
timeFrame: 35 days
measure: Efficacy of glycemic control with HCL insulin delivery assessed by mean sensor glucose level
timeFrame: 35 days
measure: Rate of infection in episodes per patient-days
timeFrame: 35 days
measure: Length of hospitalization in days per patient
timeFrame: 35 days
measure: Length of PICU admission in days per patient
timeFrame: 35 days
measure: Rate of remission at the end of induction in percent
timeFrame: 35 days
measure: Need for readmission during the induction phase in percent
timeFrame: 35 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Gregory Forlenza, MD
role: PRINCIPAL_INVESTIGATOR
References: