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

NCT05006040 | Terminated Early Phase 1 DMC FDA Device

• 2 other identifiers: 21-2695.ccP30CA046934
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

High Risk Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (6)

• CGM Time in hypoglycemia (blood glucose < 70 mg/dL)

  The primary outcome measures for this study will be the safety of HCL insulin delivery by hypoglycemia exposure. One of the primary endpoints is CGM Time in hypoglycemia (defined as blood glucose \< 70 mg/dL).

  35 days

• Number of episodes of symptomatic hypoglycemia

  The primary outcome measures for this study will be the safety of HCL insulin delivery by hypoglycemia exposure. One of the primary endpoints is the number of episodes of symptomatic hypoglycemia. At each study visit, subjects will be asked about symptoms, such as shakiness, dizziness, blurred/impaired vision, sweating, pallor, clumsiness, difficulty paying attention, tingling around the lips, tongue or cheeks, change in mental status, or seizure.

  35 days

• Rate of infection at the CGM insertion site

  Rate of infection at the CGM insertion site, measured in occurrences per patient-day.

  35 days

• Rate of bleeding at the CGM insertion site

  Rate of bleeding at the CGM insertion site, measured in occurrence per patient-day.

  35 days

• Rate of infection at the HCL insulin infusion site

  Rate of infection at the HCL insulin infusion site, measured in occurrence per patient-day.

  35 days

• Rate of bleeding at the HCL insulin infusion site

  Rate of bleeding at the HCL insulin infusion site, measured in occurrence per patient-day.

  35 days

Secondary Outcomes (7)

• Efficacy of glycemic control with HCL insulin delivery assessed by Time in Ranges (TIR)

  35 days

• Efficacy of glycemic control with HCL insulin delivery assessed by mean sensor glucose level

  35 days

• Rate of infection in episodes per patient-days

  35 days

• Length of hospitalization in days per patient

  35 days

• Length of PICU admission in days per patient

  35 days

Study Arms (1)

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

EXPERIMENTAL

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.

Device: Hybrid Closed Loop System

Interventions

Hybrid Closed Loop System DEVICE

Participants will utilize the Tandem Control-IQ Professional Hybrid Closed Loop artificial pancreas system \[25, 26\]. This device consists of the Dexcom G6 Continuous glucose monitor (or a more recent interoperable CGM), the Tandem t:slim X2 continuous subcutaneous insulin infusion pump, and the Control-IQ professional hybrid closed loop control algorithm. The CGM is generally replaced by parents or patients and then replaced after sensor expiration or if it falls off. This CGM, like all future iCGMs, is factory calibrated and approved for direct dosing of insulin. In addition, while the system is in use, patients will conduct blood glucose level checks at least four times a day with a fingerstick and calibrate the CGM if the measurements differ by more than 20 mg/dL of fingerstick blood glucose level. The t:slim X2 insulin pump delivers rapid acting insulin via a subcutaneous cannula which is placed by parents or patients and then replaced every 3 days \[30\].

Also known as: Tandem Control-IQ Professional Hybrid Closed Loop system

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

Eligibility Criteria

• Age: 10 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients ages 10 years old and above
• Patients who are newly diagnosed with high-risk acute lymphoblastic leukemia
• Patients who have started or will start an induction chemotherapy regimen containing steroid and asparaginase
• 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
• Parent or guardian living in the home with the participant who also receives training on diabetes, CGM, HCL therapy, and the safety protocols

You may not qualify if:

• Preexisting diabetes
• Severe psychiatric disease or developmental delays, that might interfere with ability to provide informed consent
• Active skin condition that would affect sensor placement
• 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:
• Significant chronic kidney disease (eGFR \<60) or requiring hemodialysis
• Significant liver disease
• History of adrenal insufficiency
• History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
• History of thyroid cancer
• Use of intravenous or oral acetaminophen more than 60 mg/kg/day (maximum 4000 mg/day)

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Children's Hospital Colorado: collaborator
• DexCom, Inc.: collaborator
• Tandem Diabetes Care, Inc.: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Study Officials

• Gregory Forlenza, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: August 16, 2021
• Study Start: May 12, 2022
• Primary Completion: June 17, 2022
• Study Completion: August 1, 2023
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)