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Insulin Delivery System
Hybrid Closed Loop System for Acute Lymphoblastic Leukemia
Phase < 1
Waitlist Available
Led By Gregory Forlenza, 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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 35 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~35 days
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 moreSecondary 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 moreTrial 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
1,757 Previous Clinical Trials
2,166,138 Total Patients Enrolled
Children's Hospital ColoradoOTHER
117 Previous Clinical Trials
5,132,820 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
138 Previous Clinical Trials
29,840 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am starting or have started chemotherapy with steroid and asparaginase.I have had thyroid cancer in the past.You have a serious mental illness or developmental delays that may affect your ability to understand and agree to participate in the study.I have untreated thyroid issues indicated by abnormal TSH levels.I have diabetes.I have a serious liver condition.I use more than 60 mg/kg/day of acetaminophen, but not over 4000 mg/day.I have been recently diagnosed with high-risk acute lymphoblastic leukemia.I have a history of adrenal insufficiency.I am 10 years old or older.You have a skin condition that could interfere with the placement of the sensors.I have severe kidney problems or am on dialysis.My caregiver at home is trained in my diabetes and therapy management.You have a health condition that could make it unsafe for you to take part in the study, as determined by the investigators.
Research Study Groups:
This trial has the following groups:- Group 1: Hybrid Closed-Loop Insulin System During Chemo with Steroid and Asparaginase
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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