Monitoring and Managing Glucose Levels in People With Pancreatic Cancer

Last updated: September 17, 2025
Sponsor: British Columbia Cancer Agency
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatitis

Pancreatic Disorders

Diabetes Mellitus, Type 2

Treatment

Standard Care

Endocrinologist-directed target blood glucose level 4-10 mmol/L using data from a continuous glucose monitor (CGM)

Clinical Study ID

NCT05132244
H21-03061
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histological/cytological diagnosis of pancreatic ductal adenocarcinoma (PDAC).

  • Planned to undergo first-line systemic therapy with FOLFIRINOX.

  • Age greater than or equal to 18 years.

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

  • Adequate bone marrow and organ function as defined by the following laboratoryvalues:

  1. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L.

  2. Platelet count greater than or equal to 75 x 10^9/L.

  3. Hemoglobin greater than or equal to 9.0 g/dL.

  4. Estimated glomerular filtration rate (GFR) by Cockroft-Gault equation OR 24hour urine collection greater than or equal to 40 ml/min.

  5. Creatinine clearance greater than or equal to 40 mL/min using Cockcroft-Gaultformula.

  6. Potassium within normal limits, or corrected with supplements.

  7. International normalized ratio (INR) less than or equal to 1.5.

  8. Total serum bilirubin less than or equal to 2 x upper limit of normal (ULN) (any elevated bilirubin should be asymptomatic at enrollment) except forparticipants with documented Gilbert's syndrome who may only be included if thetotal bilirubin less than or equal to 3 x ULN or direct bilirubin less than orequal to 1.5 x ULN).

  9. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less thanor equal to 2.5 x ULN (or less than or equal to 5 x ULN if liver metastases arepresent).

  • Able to understand and voluntarily sign the informed consent form.

  • Able to comply with the study visit schedule and other protocol requirements.

  • Able to swallow oral medications and has no contraindications to subcutaneousinsulin injections.

  • Measurable or evaluable disease by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at baseline.

  • Life expectancy of more than 90 days as judged by the study doctor.

Exclusion

Exclusion Criteria:

  • Absence of distant or lymph node metastases. Participants with borderline resectableor locally advanced PDAC are not eligible.

  • Received prior systemic therapy (chemotherapy or any other anti-cancer agent) fortreatment of metastatic PDAC. Participants who received adjuvant chemotherapy aftersurgical resection of early stage disease are eligible.

  • Currently receiving anti-cancer therapy (chemotherapy or any other anti-canceragent).

  • Not fit for combination chemotherapy as judged by the study doctor.

  • Presence of brain metastases.

  • Known diagnosis of type I diabetes where strict glucose control and closeEndocrinology follow-up is already indicated.

  • Known diagnosis of type II diabetes and already followed by Endocrinologist.

  • Female participants with a positive pregnancy test.

  • Participants who are not safe to include in the study as judged by the study doctorfor any medical or non-medical reason.

  • Unable to comply with study assessments and follow-up.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Standard Care
Phase:
Study Start date:
April 16, 2024
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • British Columbia Cancer

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • British Columbia Cancer

    Vancouver 6173331, British Columbia 5909050 V5Z 4E6
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Active - Recruiting

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