Glycemic Impact on Glioblastoma Outcomes

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.

Study Overview

• Status: Withdrawn
• Conditions: Hyperglycemia; Glioblastoma Multiforme

Detailed Description

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients who are newly diagnosed with glioblastoma

Description

Inclusion Criteria:

• Adult patients (> 18 years old) with a new histologically-confirmed diagnosis of glioblastoma who are planned to receive a 6-week course of concurrent radiation and temozolomide
• Has evidence of random glucose of at least 7.8 mmol/L or fasting blood glucose of at least 6.1 mmol/L (meeting criteria for oral diabetic medications)
• Able to provide informed consent
• Able to understand and follow instructions regarding self-administered capillary glucose measurements

Exclusion Criteria:

• Contraindication to MRI with gadolinium
• Taking anti-hyperglycemic medications at the time of study eligibility screen
• Unable to participate in neurocognitive evaluation in English

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Sinai Health System

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2018
• Primary Completion (ANTICIPATED): October 1, 2019
• Study Completion (ACTUAL): January 24, 2020

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (ACTUAL): August 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: glucose monitoring
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Hyperglycemia; Glioblastoma
• Other Study ID Numbers: 15-9329

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No