A Case-control Study Comparing Glycaemic Control in Pancreatic Cancer Patients vs Healthy Matched Individuals.
PanCanCGM
1 other identifier
observational
29
1 country
2
Brief Summary
The aim of this study is to continuously monitor blood glucose concentrations for a 7-day period in pancreatic cancer patients whilst undergoing their typical daily routines and to compare this to age matched healthy individuals. The investigators plan to carry out the study on a small subset of patients, up to 30 with pancreatic cancer (15 not undergoing chemotherapy and 15 undergoing chemotherapy) and 15 healthy individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 25, 2022
CompletedFirst Submitted
Initial submission to the registry
October 11, 2022
CompletedFirst Posted
Study publicly available on registry
October 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2024
CompletedJune 4, 2025
May 1, 2025
2 years
October 11, 2022
May 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Glycaemic control
Glycaemic control will be assessed by continuous glucose monitors for a 7-day period with activity trackers and food diaries used to further assess this control. The continuous glucose monitors takes readings every 5 minutes these readings will be averaged and area under the curve will be calculated.
7 day period
Health inequalities
Health inequalities, including household income, access to green space, main occupation, smoking habits, support system, ethnicity and religion assessed by specific questions and DipCare-Q questionnaires completed. Analyses determining the impact of inequalities on glyceamic control will be completed.
7 day period
Study Arms (3)
Healthy participants
Continuous glucose monitors will be fitted for 7 days, along with activity trackers and a food diary to monitor the impact of these factors on blood glucose concentrations. Participants will also complete questionnaires related to health inequalities and quality of life.
Pancreatic cancer patients undergoing chemotherapy
Continuous glucose monitors will be fitted for 7 days, along with activity trackers and a food diary to monitor the impact of these factors on blood glucose concentrations whilst they are undergoing chemotherapy. Participants will also complete questionnaires related to health inequalities and quality of life.
Pancreatic cancer patients not undergoing chemotherapy
Continuous glucose monitors will be fitted for 7 days, along with activity trackers and a food diary to monitor the impact of these factors on blood glucose concentrations. Participants will also complete questionnaires related to health inequalities and quality of life.
Interventions
Participants will wear continuous glucose monitors for a 7 day period.
Participants will wear the activity tracker for a 7 day period.
Participants will complete a food diary of everything they eat for 7 days.
Participants will complete FACT-Hep, DiPcare-Q and health inequality related questions.
Eligibility Criteria
Pancreatic cancer patients aged between 18 and 85 with a performance status of 2 and below. The patients must have jaundice relieved before participating and cannot have diabetes at the point of diagnosis. Healthy participants must be between 18-85 and age matched to the pancreatic cancer patients. The participants must not have any serious underlying health conditions or take any medications which may alter glycaemic control.
You may qualify if:
- Aged 18-85
- Sex: male/female
- Radiological/tissue cancer diagnosis
- World Health Organisation performance status of 2 or below
- Patients with jaundice must have jaundice relieved before participating
You may not qualify if:
- Pregnancy
- Planned surgery within the 7 days of wearing the monitor
- Emergency surgery
- Part of any other trial with similar interventions
- Any musculoskeletal, cardiovascular, or neurological disorder that could put them at risk during the protocol.
- World Health Organisation performance status of above 2.
- Have diabetes at the point of diagnosis.
- Healthy control group
- Aged 18-85
- No serious underlying health conditions
- Age matched to pancreatic cancer patients
- Take any medications which may alter blood glucose concentrations or insulin/glucagon concentrations, regular paracetamol intake during the study period, corticosteroids, thyroid hormones, or any anti-diabetes medication including insulin and oral hypoglycaemics.
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lancaster Universitylead
- East Lancashire Hospitals NHS Trustcollaborator
Study Sites (2)
Lancaster University
Lancaster, Lancashire, LA1 4YW, United Kingdom
East Lancashire Hospitals Trust
Blackburn, BB2 3HH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher J Gaffney
Lancaster University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
October 11, 2022
First Posted
October 18, 2022
Study Start
August 25, 2022
Primary Completion
August 21, 2024
Study Completion
August 28, 2024
Last Updated
June 4, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share