HCL Single Arm Pilot Study in Treatment of Hyperglycemia of Pediatric ALL

University of Colorado Denver (CU Denver)

Status and phase: Terminated; Early Phase 1

Conditions: High Risk Acute Lymphoblastic Leukemia

Treatments: Device: Hybrid Closed Loop System

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05006040

21-2695.cc

P30CA046934 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 10 to 26 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Hybrid Closed-Loop Insulin System During Chemo with Steroid and Asparaginase

Experimental group

Description:

Subjects will receive insulin via hybrid closed-loop insulin delivery system during the chemotherapy phases that contains steroid and asparaginase. This treatment will be initiated within 4 days of starting induction chemotherapy treatment.

Treatment:

Device: Hybrid Closed Loop System