Clinical trial · Interventional
HCL Single Arm Pilot Study in Treatment of Hyperglycemia of Pediatric ALL
Safety and Feasibility Study of a Hybrid Closed-loop Insulin Delivery System for Children and Young Adults With High Risk Acute Lymphoblastic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low Accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Risk Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hybrid Closed Loop System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hybrid Closed-Loop Insulin System During Chemo with Steroid and Asparaginase
- 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.
- interventionNames
- Device: Hybrid Closed Loop System
Primary outcomes (6)
- measure
- CGM Time in hypoglycemia (blood glucose < 70 mg/dL)
- timeFrame
- 35 days
- 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).
- measure
- Number of episodes of symptomatic hypoglycemia
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 26 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients ages 10 years old and above 2. Patients who are newly diagnosed with high-risk acute lymphoblastic leukemia 3. Patients who have started or will start an induction chemotherapy regimen containing steroid and asparaginase 4. 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 5. 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: 1. Preexisting diabetes 2. Severe psychiatric disease or developmental delays, that might interfere with ability to provide informed consent 3. Active skin condition that would affect sensor placement 4. 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: 1. Significant chronic kidney disease (eGFR \<60) or requiring hemodialysis 2. Significant liver disease 3. History of adrenal insufficiency 4. History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated 5. History of thyroid cancer 5. Use of intravenous or oral acetaminophen more than 60 mg/kg/day (maximum 4000 mg/day)
References
Publications (0)
Data not yet available