High Risk Acute Lymphoblastic LeukemiaEarly Phase 1NCT05006040
HCL Single Arm Pilot Study in Treatment of Hyperglycemia of Pediatric ALL
A Early Phase 1 study testing Hybrid Closed Loop System in people with High Risk Acute Lymphoblastic Leukemia, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 26 years
- Conditions the study is for
- High Risk Acute Lymphoblastic Leukemia
- What is being tested?
- Hybrid Closed Loop System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2022to 1 Aug 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
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
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.
Read the 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.
- Conditions
- High Risk Acute Lymphoblastic Leukemia
- Being tested
- Hybrid Closed Loop System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Closed Loop SystemDevice
Also called Tandem Control-IQ Professional Hybrid Closed Loop system
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].
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hybrid Closed Loop System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 35 days
Rate of infection at the CGM insertion site
Rate of infection at the CGM insertion site, measured in occurrences per patient-day.
Measured: 35 days
Rate of bleeding at the CGM insertion site
Rate of bleeding at the CGM insertion site, measured in occurrence per patient-day.
Measured: 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.
Measured: 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.
Measured: 35 days
Secondary outcomes (7)
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.
Measured: 35 days
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
Measured: 35 days
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.
Measured: 35 days
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.
Measured: 35 days
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.
Measured: 35 days
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.
Measured: 35 days
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.
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start12 May 2022
- Primary completion17 Jun 2022
- Study completion1 Aug 2023
Why it stopped: Low Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado, DexCom, Inc., Tandem Diabetes Care, Inc., National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gregory Forlenza, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006040
- Sponsor's protocol ID
- 21-2695.cc
- Other IDs
- P30CA046934
- Status last verified
- May 2024
- First submitted
- 7 Jul 2021
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05006040
- Acronym / sponsor ID
- 21-2695.cc
- Conditions
- High Risk Acute Lymphoblastic Leukemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado, DexCom, Inc., Tandem Diabetes Care, Inc., National Cancer Institute (NCI)
- Study start
- 12 May 2022 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Hybrid Closed-Loop Insulin System During Chemo with Steroid and Asparaginase | Experimental | Device: Hybrid Closed Loop SystemSubjects 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. |
Who may qualify
- Ages
- 10 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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:
- Use of intravenous or oral acetaminophen more than 60 mg/kg/day (maximum 4000 mg/day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid Closed Loop SystemAlso: Tandem Control-IQ Professional Hybrid Closed Loop systemParticipants 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]. | Device | Hybrid Closed-Loop Insulin System During Chemo with Steroid and Asparaginase |
Primary outcome
CGM Time in hypoglycemia (blood glucose < 70 mg/dL)
Time frame: 35 days
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
Time frame: 35 days
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
Time frame: 35 days
Rate of infection at the CGM insertion site, measured in occurrences per patient-day.
Rate of bleeding at the CGM insertion site
Time frame: 35 days
Rate of bleeding at the CGM insertion site, measured in occurrence per patient-day.
Rate of infection at the HCL insulin infusion site
Time frame: 35 days
Rate of infection at the HCL insulin infusion site, measured in occurrence per patient-day.
Rate of bleeding at the HCL insulin infusion site
Time frame: 35 days
Rate of bleeding at the HCL insulin infusion site, measured in occurrence per patient-day.
7 secondary outcomes
Efficacy of glycemic control with HCL insulin delivery assessed by Time in Ranges (TIR)
Time frame: 35 days
Efficacy of glycemic control with HCL insulin delivery assessed by mean sensor glucose level
Time frame: 35 days
Rate of infection in episodes per patient-days
Time frame: 35 days
Length of hospitalization in days per patient
Time frame: 35 days
Length of PICU admission in days per patient
Time frame: 35 days
Rate of remission at the end of induction in percent
Time frame: 35 days
Need for readmission during the induction phase in percent
Time frame: 35 days
Results and safety
The study was stopped early (reason given: Low Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Forlenza, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hybrid Closed Loop System in people with High Risk Acute Lymphoblastic Leukemia, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low Accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CGM Time in hypoglycemia (blood glucose < 70 mg/dL) (time frame: 35 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.