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Insulin Delivery System

Hybrid Closed Loop System for Acute Lymphoblastic Leukemia

Phase < 1
Recruiting
Led By Soohee Cho, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who have started or will start an induction chemotherapy regimen containing steroid and asparaginase
Patients who are newly diagnosed with high-risk acute lymphoblastic leukemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 35 days
Awards & highlights

Study Summary

This trial is testing a new system for delivering insulin to children and young adults with leukemia, during treatment that can cause high blood sugar levels.

Who is the study for?
This trial is for children and young adults over 10 years old newly diagnosed with high-risk acute lymphoblastic leukemia undergoing induction chemotherapy. Participants must speak English, and those under 18 need a guardian who can also learn about diabetes management. It's not for those with preexisting diabetes, significant kidney or liver disease, untreated thyroid issues, heavy acetaminophen use, skin conditions affecting sensor placement, or severe psychiatric diseases.Check my eligibility
What is being tested?
The study tests the safety and practicality of using a hybrid closed-loop insulin delivery system to manage high blood sugar in pediatric patients during their first phase of leukemia treatment when they're taking steroids and asparaginase that can cause hyperglycemia.See study design
What are the potential side effects?
While specific side effects are not listed for this device-based intervention (hybrid closed-loop insulin delivery system), potential risks may include discomfort at the insertion site of sensors or infusion sets used by the system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am starting or have started chemotherapy with steroid and asparaginase.
Select...
I have been recently diagnosed with high-risk acute lymphoblastic leukemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~35 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 35 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CGM Time in hypoglycemia (blood glucose < 70 mg/dL)
Number of episodes of symptomatic hypoglycemia
Rate of bleeding at the CGM insertion site
+3 more
Secondary outcome measures
Efficacy of glycemic control with HCL insulin delivery assessed by Time in Ranges (TIR)
Efficacy of glycemic control with HCL insulin delivery assessed by mean sensor glucose level
Length of PICU admission in days per patient
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hybrid Closed-Loop Insulin System During Chemo with Steroid and AsparaginaseExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Hybrid Closed Loop System
2016
N/A
~90

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,506 Total Patients Enrolled
Children's Hospital ColoradoOTHER
116 Previous Clinical Trials
5,132,595 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
137 Previous Clinical Trials
29,825 Total Patients Enrolled

Media Library

Hybrid Closed Loop System (Insulin Delivery System) Clinical Trial Eligibility Overview. Trial Name: NCT05006040 — Phase < 1
Acute Lymphoblastic Leukemia Research Study Groups: Hybrid Closed-Loop Insulin System During Chemo with Steroid and Asparaginase
Acute Lymphoblastic Leukemia Clinical Trial 2023: Hybrid Closed Loop System Highlights & Side Effects. Trial Name: NCT05006040 — Phase < 1
Hybrid Closed Loop System (Insulin Delivery System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05006040 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this research project open to me?

"A clinical trial is underway to enrol 20 participants between the ages of 10 and 26 who have acute lymphocytic leukemia (L1). Additional criteria for qualification include having commenced or about to commence an induction chemotherapy regimen that contains corticosteroids as well as asparaginase, plus a parent/guardian living in the same home with adequate training on diabetes management, continuous glucose monitoring, HCL therapy and safety protocol."

Answered by AI

Is enrollment open for this clinical research experiment?

"Affirmative. The information hosted on clinicaltrials.gov indicates that the trial is still open to accepting participants, which was initially published on March 21st 2022 and amended most recently on April 7th 2022. This medical study requires 20 patients from a single location."

Answered by AI

Is the age criterion for this experiment restricted to individuals under thirty?

"The recruitment criteria for this trial necessitates that participants are between the age of 10 and 26."

Answered by AI

How many participants are currently engaging in this clinical investigation?

"Indeed, according to clinicaltrials.gov, this trial is actively enrolling individuals and was first announced on March 21st 2022. The most recent update occurred April 7th of the same year, and the study requires 20 patients at a single location to move forward."

Answered by AI

What are the main goals of this research endeavor?

"Over the course of 35 days, this clinical trial will primarily measure CGM Time in Hypoglycemia (blood glucose < 70 mg/dL) as a primary outcome. Secondary outcomes include Length of PICU Admission in Days Per Patient and Rate of Remission at the End of Induction in Percent; both compared against a historical control group to determine effect sizes for future studies and grant proposals. Lastly, Efficacy Of Glycemic Control With HCL Insulin Delivery is assessed with Time In Ranges (TIRs); which represents percent time spent within certain specified blood sugar levels between 70-180 or occasionally 70-140mg"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
HCL Single Arm Pilot Study in Treatment of Hyperglycemia of Pediatric ALL
2022. "HCL Single Arm Pilot Study in Treatment of Hyperglycemia of Pediatric ALL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05006040.
~7 spots leftby Apr 2025
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