Pancreatic CancerPanCanCGMNCT05583890
A Case-control Study Comparing Glycaemic Control in Pancreatic Cancer Patients vs Healthy Matched Individuals.
An observational study of Pancreatic Cancer, run by Lancaster University at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Continuous glucose monitors, Activity tracker and Food Diary
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 29 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 25 Aug 2022to 28 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
- Aged 18-85
- No serious underlying health conditions
- Age matched to pancreatic cancer patients
Who cannot join
- 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.
Show all 10Show fewer
- Have diabetes at the point of diagnosis.
- Healthy control group
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
East Lancashire Hospitals Trust
Blackburn, BB2 3HH
Lancaster University
Lancaster, Lancashire, LA1 4YW
About this study
Official title: A Case-control Study Comparing Glycaemic Control in Pancreatic Cancer Patients Versus Age Matched Healthy Individuals Using Continuous Glucose Monitors.
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.
Read the detailed description
The pancreas has two key functions related to digestion and metabolism. The first function of the pancreas is to produce exocrine enzymes which are released into the small intestine to help with the digestion of food. The second function is to produce endocrine hormones, such as insulin and glucagon, which help regulate glycaemic control. Impaired glucose metabolism and pancreatic cancer is temporally and pathogenically linked, with pancreatic tumours altering the secretion of key glucose regulatory hormones. Improved glucose regulation and lower glucose concentrations 3 months post-diagnosis of pancreatic ductal adenocarcinoma, a type of pancreatic cancer, has shown to increase overall survival.
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 comparison between healthy individuals and pancreatic cancer patients will investigate the severity of the difference between healthy glycaemic control and glycaemic control in those with pancreatic cancer. The comparison between pancreatic cancer patients undergoing chemotherapy and those not undergoing chemotherapy will help investigate the impact of chemotherapy on glycaemic control. This will help provide evidence as to what impact pancreatic cancer has on glycaemic control, whether continuous glucose monitors might be useful to regulate symptoms in patients, as a baseline to tailor an exercise intervention to regulate blood glucose concentrations and to investigate whether health inequalities impact glycaemic control.
The investigators plan to carry out the study on a small subset of patients, 30 with pancreatic cancer (15 undergoing chemotherapy and 15 not undergoing chemotherapy) and 15 healthy individuals.
- Conditions
- Pancreatic Cancer
- Being tested
- Continuous glucose monitors, Activity tracker, Food Diary, Questionnaires
- Keywords
- Glycaemic control, Continuous glucose monitoring
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitorsDevice
Participants will wear continuous glucose monitors for a 7 day period.
Activity trackerDevice
Participants will wear the activity tracker for a 7 day period.
Food DiaryBehavioural
Participants will complete a food diary of everything they eat for 7 days.
QuestionnairesBehavioural
Participants will complete FACT-Hep, DiPcare-Q and health inequality related questions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continuous glucose monitors; Device: Activity tracker; Behavioral: Food Diary; Behavioral: Questionnaires | |
| 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. Receives: Device: Continuous glucose monitors; Device: Activity tracker; Behavioral: Food Diary; Behavioral: Questionnaires | |
| 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. Receives: Device: Continuous glucose monitors; Device: Activity tracker; Behavioral: Food Diary; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start25 Aug 2022
- Primary completion21 Aug 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancaster University
- Sponsor type
- University, hospital or other
- Collaborators
- East Lancashire Hospitals NHS Trust
- Responsible party
- Principal investigator, Dr. Chris Gaffney, Lancaster University
- Investigators
- Christopher J Gaffney, Principal investigator, Lancaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583890
- Sponsor's protocol ID
- NHS REC no: 315235
- Acronym
- PanCanCGM
- Status last verified
- May 2025
- First submitted
- 11 Oct 2022
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-control Study Comparing Glycaemic Control in Pancreatic Cancer Patients Versus Age Matched Healthy Individuals Using Continuous Glucose Monitors.
- ClinicalTrials.gov ID
- NCT05583890
- Acronym / sponsor ID
- PanCanCGM / NHS REC no: 315235
- Conditions
- Pancreatic Cancer
- Keywords
- Glycaemic control, Continuous glucose monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Lancaster UniversityUniversity, hospital or other
- Collaborators
- East Lancashire Hospitals NHS Trust
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The pancreas has two key functions related to digestion and metabolism. The first function of the pancreas is to produce exocrine enzymes which are released into the small intestine to help with the digestion of food. The second function is to produce endocrine hormones, such as insulin and glucagon, which help regulate glycaemic control. Impaired glucose metabolism and pancreatic cancer is temporally and pathogenically linked, with pancreatic tumours altering the secretion of key glucose regulatory hormones. Improved glucose regulation and lower glucose concentrations 3 months post-diagnosis of pancreatic ductal adenocarcinoma, a type of pancreatic cancer, has shown to increase overall survival.
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 comparison between healthy individuals and pancreatic cancer patients will investigate the severity of the difference between healthy glycaemic control and glycaemic control in those with pancreatic cancer. The comparison between pancreatic cancer patients undergoing chemotherapy and those not undergoing chemotherapy will help investigate the impact of chemotherapy on glycaemic control. This will help provide evidence as to what impact pancreatic cancer has on glycaemic control, whether continuous glucose monitors might be useful to regulate symptoms in patients, as a baseline to tailor an exercise intervention to regulate blood glucose concentrations and to investigate whether health inequalities impact glycaemic control.
The investigators plan to carry out the study on a small subset of patients, 30 with pancreatic cancer (15 undergoing chemotherapy and 15 not undergoing chemotherapy) and 15 healthy individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Device: Continuous glucose monitors, Device: Activity tracker, Behavioral: Food Diary, Behavioral: QuestionnairesContinuous 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 | – | Device: Continuous glucose monitors, Device: Activity tracker, Behavioral: Food Diary, Behavioral: QuestionnairesContinuous 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 | – | Device: Continuous glucose monitors, Device: Activity tracker, Behavioral: Food Diary, Behavioral: QuestionnairesContinuous 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitorsParticipants will wear continuous glucose monitors for a 7 day period. | Device | Healthy participants, Pancreatic cancer patients not undergoing chemotherapy, Pancreatic cancer patients undergoing chemotherapy |
| Activity trackerParticipants will wear the activity tracker for a 7 day period. | Device | Healthy participants, Pancreatic cancer patients not undergoing chemotherapy, Pancreatic cancer patients undergoing chemotherapy |
| Food DiaryParticipants will complete a food diary of everything they eat for 7 days. | Behavioural | Healthy participants, Pancreatic cancer patients not undergoing chemotherapy, Pancreatic cancer patients undergoing chemotherapy |
| QuestionnairesParticipants will complete FACT-Hep, DiPcare-Q and health inequality related questions. | Behavioural | Healthy participants, Pancreatic cancer patients not undergoing chemotherapy, Pancreatic cancer patients undergoing chemotherapy |
Primary outcome
Glycaemic control
Time frame: 7 day period
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.
Health inequalities
Time frame: 7 day period
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J Gaffney principal investigator
Lancaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Lancaster University at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemic control (time frame: 7 day period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.