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Logistical Issues
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| Name | Class |
|---|---|
| Sinai Health System | OTHER |
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This pilot study aims to evaluate the feasibility of close glucose monitoring and management of patients (targeting fasting and pre-meal glucose of 4-7 mmol/L) using state-of-the-art flash glucose monitoring (FGM) technology. The glycemic intervention will be personalized based on individual blood glucose levels. Although the glycemic interventions used in this study include standard medications and methods of glucose monitoring used for patients with diabetes, this pilot study will specifically evaluate the feasibility of using these approaches in patients with GBM, appreciating their additional medical, functional and social challenges.
The purpose of this pilot study is to determine the feasibility of using close monitoring and management of glucose levels in patients undergoing radiation and chemotherapy for glioblastoma.
The glucose management will include the use of standard metformin a common treatment for patients with early type 2 diabetes that has also shown anti-tumor effects in GBM, and will be further personalized based on individual blood glucose levels. Additional anti-hyperglycemic management will be provided at the discretion of the Endocrinologist.
Close glucose monitoring will include flash glucose monitoring (FGM) with a device called an FreeStyle Libre Pro Flash Glucose Monitoring System, finger-prick glucose measures (standard approach for patients with diabetes) and weekly blood tests (our current standard for patients with GBM).
In addition to determining the feasibility of using these approaches, this pilot study will help identify the simplest and most effective approach of managing glucose levels in patients with GBM appreciating their additional medical, functional and social challenges.
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| Measure | Description | Time Frame |
|---|---|---|
| Total time spent in target glucose level | total time spent in target range of 4-10 mmol/L based on FGM data during week 6 of radiotherapy and temozolomide therapy | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve for glycemic exposure and variability | Glucose levels measured using FGM vs conventional clinical measures (e.g. capillary blood glucose) | baseline, week 1, 2, 3, 4, 5, 6, 10-13, 3 months |
| Neurocognitive Function |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients who are newly diagnosed with glioblastoma
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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To explore the association between glycemia and neurocognitive functions patients will undergo standardized tests
| Baseline |
| Neurocognitive Function | To explore the association between glycemia and neurocognitive functions patients will undergo standardized tests | After week 10 and before week 13 |
| Neurocognitive Function | To explore the association between glycemia and neurocognitive functions patients will undergo standardized tests | 3 month follow up visit |
| prevalence of sensor site problems | infection, irritation, and secondary complication in the study cohort | From baseline to week 6 - the time from sensor insertion through completion of study intervention |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |