Clinical trial · Observational
Glucose Monitoring to Predict and Treat High Glucose Levels After Steroid Treatment
Continuous Glucose Monitoring For Prediction and Treatment of Steroid-Induced Hyperglycemia
NCT04210128CI-TRIAL-00070989completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to see if continuous glucose monitoring can identify how often people who have pre-diabetes or medical obesity or well-controlled diabetes experience very high glucose values while receiving chemotherapy for breast cancer or pancreatic.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Diabetes | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pre Diabetes | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Breast cancer patients
- description
- A blinded continuous glucose monitor (specifically a Freestyle Libre Pro) will be worn for a 14 day period by patients during the first and third cycles of breast neoadjuvant chemotherapy. At the end of that period (after completion of the one round of chemotherapy) readings will be downloaded from the sensor and the sensor will be removed. Readings will be evaluated by the treating endocrinologist as well as the study team and appropriate clinical interventions.
- label
- Pancreatic cancer patients
- description
- A blinded continuous glucose monitor (specifically a Freestyle Libre Pro) will be worn for a 14 day period by patients during the first and third cycles of pancreatic chemotherapy. At the end of that period (after completion of the one round of chemotherapy) readings will be downloaded from the sensor and the sensor will be removed. Readings will be evaluated by the treating endocrinologist as well as the study team and appropriate clinical interventions.
Primary outcomes (1)
- measure
- severe hyperglycemia
- timeFrame
- 1 year
- description
- glucose \> 400 mg/dL for over 3 contiguous hours
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient aged 18 or older undergoing neoadjuvant chemotherapy regimens including taxane and/or anthracycline for breast cancer. * Patient aged 18 or older undergoing any chemotherapy regimen for pancreatic cancer * Have 'high metabolic risk(either pre-diabetes, obesity, or well-controlled diabetes) defined as either: * Pre-diabetes and/or obesity group: one or more of known HbA1c 5.7-6.5%, fasting glucose \> 100 mg/dL, or BMI \> 30 * Well-controlled diabetes: Known HbA1c \< 7.5 on lifestyle alone or up to one oral antidiabetic agent * Any patient undergoing treatment for pancreatic adenocarcinoma on either no antidiabetic agent or up to one oral antidiabetic agent Exclusion Criteria: * Patients with type 1 diabetes, a history of hospitalization for either hyperglycemia or ketoacidosis, a history of hypoglycemia requiring hospitalization, rashes or other skin reactions that would preclude placement of the CGM * Use of anticoagulants or antiplatelet agents other than aspirin * Platelet count \< 50 K/μL within 60 days prior to enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.