NCT05132244

Monitoring and Managing Glucose Levels in People With Pancreatic Cancer

Pancreatic Cancer Glucose Assessment and Regulation Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: British Columbia Cancer Agency · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate whether or not it is feasible to closely monitor and manage glucose levels in people with pancreatic cancer. It will also investigate what impact glucose management may have on pancreatic cancer. This is a pilot study that will use continuous glucose monitors (CGM) to monitor glucose levels in approximately 50 participants with pancreatic cancer. Participants will receive standard chemotherapy with a combination of up to four drugs to treat their pancreatic cancer: oxaliplatin, irinotecan, 5-fluorouracil, and leucovorin (FOLFIRINOX). To treat high glucose levels, participants will be randomly assigned to one of two groups: Group 1 will receive anti-hyperglycemic treatment as guided by an endocrinologist with the aim of maintaining glucose levels between 4 and 10 mmol/L; Group 2 will receive anti-hyperglycemic treatment if their glucose levels are above 15 mmol/L, which is standard care. Participants in both Groups 1 and 2 will receive standard anti-hyperglycemic treatments: metformin, insulin, glucagon-like peptide-1 (GLP-1) receptor agonists, sodium glucose co-transporter (SGLT2) inhibitors, and dipeptidyl peptidase 4 (DPP-4) inhibitors. After 4 cycles of FOLFIRINOX, the CGM will be removed but any anti-hyperglycemic treatments will continue as needed. If participants discontinue treatment with FOLFIRINOX, they will continue to be followed for survival and subsequent anti-cancer therapy and will continue follow-up for glucose-related concerns at the discretion of their endocrinologist and/or medical oncologist.

Conditions

• Pancreatic Cancer
• PDAC - Pancreatic Ductal Adenocarcinoma
• Hyperglycemia

Interventions

Type	Name	Description
PROCEDURE	Endocrinologist-directed target blood glucose level 4-10 mmol/L using data from a continuous glucose monitor (CGM)	Standard anti-hyperglycemic treatment given as directed by an endocrinologist to maintain blood glucose level within 4-10 mmol/L based on data from a continuous glucose monitor (CGM) and standard blood work drawn prior to each cycle of chemotherapy. Participants will have access to their glucose data from the CGM.
OTHER	Standard Care	Standard anti-hyperglycemic treatment given only if blood glucose level is greater than 15 mmol/L as measured from standard blood work drawn prior to each cycle of chemotherapy. Participants will wear a continuous glucose monitor (CGM) but will not have access to their glucose data. Participants may be referred to an endocrinologist at the discretion of their medical oncologist.

Timeline

• Start date: 2024-04-16
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2021-11-24
• Last updated: 2025-09-22

Locations

2 sites across 1 country: Canada