Back to resultsHCL Single Arm Pilot Study in Treatment of Hyperglycemia of Pediatric ALL
Primary Purpose
High Risk Acute Lymphoblastic Leukemia
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hybrid Closed Loop System
Sponsored by
About this trial
This is an interventional treatment trial for High Risk Acute Lymphoblastic Leukemia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Children's Hospital ColoradoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hybrid Closed-Loop Insulin System During Chemo with Steroid and Asparaginase
Arm 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.
Outcomes
Primary Outcome Measures
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).
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.
Rate of infection at the CGM insertion site
Rate of infection at the CGM insertion site, measured in occurrences per patient-day.
Rate of bleeding at the CGM insertion site
Rate of bleeding at the CGM insertion site, measured in occurrence per patient-day.
Rate of infection at the HCL insulin infusion site
Rate of infection at the HCL insulin infusion site, measured in occurrence per patient-day.
Rate of bleeding at the HCL insulin infusion site
Rate of bleeding at the HCL insulin infusion site, measured in occurrence per patient-day.
Secondary Outcome Measures
Efficacy of glycemic control with HCL insulin delivery assessed by Time in Ranges (TIR)
Time in Ranges (TIRs) refers to percent of the time spent in a specific range of blood glucose levels, adding valuable information to assess the level of glycemic control. Usually a range of 70-180 mg/dL is used, but occasionally a more stringent 70-140 mg/dL is used. In this study, we will obtain %CGM TIRs in both ranges.
Efficacy of glycemic control with HCL insulin delivery assessed by mean sensor glucose level
Mean glucose level will be obtained from CGM data to evaluate for glycemic variability
Rate of infection in episodes per patient-days
Rate of infection, length of hospitalization, length of PICU admission, rate of remission at the end of induction, and need for re-admission will be obtained as a part of clinical outcomes. These outcomes will be compared to a historical control group to investigate the effect size of relationships between glycemic control and clinical outcome. This exploratory aim will investigate correlations between glycemic control and outcomes to determine effect sizes for future studies and grant proposals.
Length of hospitalization in days per patient
Rate of infection, length of hospitalization, length of PICU admission, rate of remission at the end of induction, and need for re-admission will be obtained as a part of clinical outcomes. These outcomes will be compared to a historical control group to investigate the effect size of relationships between glycemic control and clinical outcome. This exploratory aim will investigate correlations between glycemic control and outcomes to determine effect sizes for future studies and grant proposals.
Length of PICU admission in days per patient
Rate of infection, length of hospitalization, length of PICU admission, rate of remission at the end of induction, and need for re-admission will be obtained as a part of clinical outcomes. These outcomes will be compared to a historical control group to investigate the effect size of relationships between glycemic control and clinical outcome. This exploratory aim will investigate correlations between glycemic control and outcomes to determine effect sizes for future studies and grant proposals.
Rate of remission at the end of induction in percent
Rate of infection, length of hospitalization, length of PICU admission, rate of remission at the end of induction, and need for re-admission will be obtained as a part of clinical outcomes. These outcomes will be compared to a historical control group to investigate the effect size of relationships between glycemic control and clinical outcome. This exploratory aim will investigate correlations between glycemic control and outcomes to determine effect sizes for future studies and grant proposals.
Need for readmission during the induction phase in percent
Rate of infection, length of hospitalization, length of PICU admission, rate of remission at the end of induction, and need for re-admission will be obtained as a part of clinical outcomes. These outcomes will be compared to a historical control group to investigate the effect size of relationships between glycemic control and clinical outcome. This exploratory aim will investigate correlations between glycemic control and outcomes to determine effect sizes for future studies and grant proposals.
Full Information
NCT ID
NCT05006040
First Posted
July 7, 2021
Last Updated
April 12, 2023
Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado, DexCom, Inc., Tandem Diabetes Care, Inc., National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05006040
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2022 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado, DexCom, Inc., Tandem Diabetes Care, Inc., National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Risk Acute Lymphoblastic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hybrid Closed-Loop Insulin System During Chemo with Steroid and Asparaginase
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Hybrid Closed Loop System
Other Intervention Name(s)
Tandem Control-IQ Professional Hybrid Closed Loop system
Intervention Description
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].
Primary Outcome Measure Information:
Title
CGM Time in hypoglycemia (blood glucose < 70 mg/dL)
Description
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).
Time Frame
35 days
Title
Number of episodes of symptomatic hypoglycemia
Description
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.
Time Frame
35 days
Title
Rate of infection at the CGM insertion site
Description
Rate of infection at the CGM insertion site, measured in occurrences per patient-day.
Time Frame
35 days
Title
Rate of bleeding at the CGM insertion site
Description
Rate of bleeding at the CGM insertion site, measured in occurrence per patient-day.
Time Frame
35 days
Title
Rate of infection at the HCL insulin infusion site
Description
Rate of infection at the HCL insulin infusion site, measured in occurrence per patient-day.
Time Frame
35 days
Title
Rate of bleeding at the HCL insulin infusion site
Description
Rate of bleeding at the HCL insulin infusion site, measured in occurrence per patient-day.
Time Frame
35 days
Secondary Outcome Measure Information:
Title
Efficacy of glycemic control with HCL insulin delivery assessed by Time in Ranges (TIR)
Description
Time in Ranges (TIRs) refers to percent of the time spent in a specific range of blood glucose levels, adding valuable information to assess the level of glycemic control. Usually a range of 70-180 mg/dL is used, but occasionally a more stringent 70-140 mg/dL is used. In this study, we will obtain %CGM TIRs in both ranges.
Time Frame
35 days
Title
Efficacy of glycemic control with HCL insulin delivery assessed by mean sensor glucose level
Description
Mean glucose level will be obtained from CGM data to evaluate for glycemic variability
Time Frame
35 days
Title
Rate of infection in episodes per patient-days
Description
Rate of infection, length of hospitalization, length of PICU admission, rate of remission at the end of induction, and need for re-admission will be obtained as a part of clinical outcomes. These outcomes will be compared to a historical control group to investigate the effect size of relationships between glycemic control and clinical outcome. This exploratory aim will investigate correlations between glycemic control and outcomes to determine effect sizes for future studies and grant proposals.
Time Frame
35 days
Title
Length of hospitalization in days per patient
Description
Rate of infection, length of hospitalization, length of PICU admission, rate of remission at the end of induction, and need for re-admission will be obtained as a part of clinical outcomes. These outcomes will be compared to a historical control group to investigate the effect size of relationships between glycemic control and clinical outcome. This exploratory aim will investigate correlations between glycemic control and outcomes to determine effect sizes for future studies and grant proposals.
Time Frame
35 days
Title
Length of PICU admission in days per patient
Description
Rate of infection, length of hospitalization, length of PICU admission, rate of remission at the end of induction, and need for re-admission will be obtained as a part of clinical outcomes. These outcomes will be compared to a historical control group to investigate the effect size of relationships between glycemic control and clinical outcome. This exploratory aim will investigate correlations between glycemic control and outcomes to determine effect sizes for future studies and grant proposals.
Time Frame
35 days
Title
Rate of remission at the end of induction in percent
Description
Rate of infection, length of hospitalization, length of PICU admission, rate of remission at the end of induction, and need for re-admission will be obtained as a part of clinical outcomes. These outcomes will be compared to a historical control group to investigate the effect size of relationships between glycemic control and clinical outcome. This exploratory aim will investigate correlations between glycemic control and outcomes to determine effect sizes for future studies and grant proposals.
Time Frame
35 days
Title
Need for readmission during the induction phase in percent
Description
Rate of infection, length of hospitalization, length of PICU admission, rate of remission at the end of induction, and need for re-admission will be obtained as a part of clinical outcomes. These outcomes will be compared to a historical control group to investigate the effect size of relationships between glycemic control and clinical outcome. This exploratory aim will investigate correlations between glycemic control and outcomes to determine effect sizes for future studies and grant proposals.
Time Frame
35 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soohee Cho, MD
Phone
(720) 777-6740
Email
soohee.cho@childrenscolorado.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soohee Cho, MD
Organizational Affiliation
Children's Hospital Colorado
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soohee Cho, MD
Phone
720-777-6740
Email
soohee.cho@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Soohee Cho, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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HCL Single Arm Pilot Study in Treatment of Hyperglycemia of Pediatric ALL
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