Pancreas CancerFiGluRNCT06774170
Structured Follow-up Intervention on Glucose Status After Pancreatic Cancer Surgery
A study testing structured follow-up intervention in people with Pancreas Cancer and Diabetes, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of the present study is to examine the effect of a "structured follow-up intervention" to be performed in the first three months after PD on blood glucose. The exploratory aim of the study is to examine the effect of the "structured follow-up intervention" to be performed in the first three months… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreas Cancer, Diabetes
- What is being tested?
- structured follow-up intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The inclusion criteria for the particioants were; being over 18 years of age, being a smartphone user compatible with the Dexcom G6 application, having an internet connection, having a Mini Mental Test result of over 22 points for educated individuals and over 19 points for uneducated individuals, being willing to participate in the study, and having undergone pancreaticoduodenectomy.
- In the study, "able to swallow table" is not eligibility criteria due to tablet (medication) adherence is not assssed In the study, patients with and without preoperative diabetes mellitus type II were included in the sample. Block randomization was performed according to the presence of DM. Therefore, the presence of diabetes is not an exclusion criterion.
- In the literature, thyroid disease has not been identified as an exclusion criterion in studies related to pancreatogenic diabetes. The endocrinologist involved in this project did not find it necessary to add thyroid disease as an exclusion criterion.
Who cannot join
- Exclusion criteria were; having developed sepsis after surgery, having been diagnosed with insulinoma, glycogonoma, ectopic ACTH syndrome before surgery, having been diagnosed with a psychiatric disease, clinical diagnosis of Alzheimer's Disease and being hospitalized.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Dokuz Eylul University
Izmir, Balcova Inciralti, 35340
About this study
Official title: Effect of Structured Follow-up Intervention on Glucose Status After Pancreatic Cancer Surgery: a Randomized Controlled Trial
The primary aim of the present study is to examine the effect of a "structured follow-up intervention" to be performed in the first three months after PD on blood glucose. The exploratory aim of the study is to examine the effect of the "structured follow-up intervention" to be performed in the first three months after PD on patient outcomes (mortality, rehospitalization and having surgery, wound site complications, bile leakage, delayed gastric emptying, pancreatic fistula, myocardial infarct, cardiac arythmia, pneumonia, intraabdominal abscess, bleeding and pain) and the quality of life. The secondary aim of the study is to evaluate the factors affecting glucose levels in three months after PD by using data mining. Data mining will allow evaluation of all the factors affecting glucose levels by using detailed blood glucose predictors obtained through continuous glucose monitoring after PD. The study has a single-center, randomized, controlled, single-blind design. The study sample will include 40 patients with PD. The allocation ratio will be 1:1. Since being diagnosed as diabetes before surgery is an important variable, block randomization will be performed depending on whether the patients have the diagnosis of diabetes.
Read the detailed description
The primary aim of the present study is to examine the effect of a "structured follow-up intervention" to be performed in the first three months after PD on blood glucose. The exploratory aim of the study is to examine the effect of the "structured follow-up intervention" to be performed in the first three months after PD on patient outcomes (mortality, rehospitalization and having surgery, wound site complications, bile leakage, delayed gastric emptying, pancreatic fistula, myocardial infarct, cardiac arythmia, pneumonia, intraabdominal abscess, bleeding and pain) and the quality of life. The secondary aim of the study is to evaluate the factors affecting glucose levels in three months after PD by using data mining. Data mining will allow evaluation of all the factors affecting glucose levels by using detailed blood glucose predictors obtained through continuous glucose monitoring after PD. The study has a single-center, randomized, controlled, single-blind design. The study sample will include 40 patients with PD. The allocation ratio will be 1:1. Since being diagnosed as diabetes before surgery is an important variable, block randomization will be performed depending on whether the patients have the diagnosis of diabetes.
- Conditions
- Pancreas Cancer, Diabetes
- Being tested
- structured follow-up intervention
- Keywords
- pancreas cancer, pancreaticoduodenectomy, continuous glucose monitoring, type 3c diabetes mellitus, data mining
- Medical subject headings
- Pancreatic Neoplasms, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
structured follow-up interventionBehavioural
The intervention has been created in light of the studies including type 1 and type 2 diabetes patients and experiences of the project team with patients after PD. Theoretical background of the intervention is based on the interventions developed for glucose management in type 1 and type 2 diabetes patients and the effect of the intervention will be evaluated by using the "plan-do-check-act" model.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Structured follow-up intervention will be performed Receives: Behavioral: structured follow-up intervention |
| Control group | No intervention | Routine post-operative follow-up and education will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
HbA1c
Measured: Three months
fasting blood glucose
fasting blood glucose
Measured: Three months
mean glucose
As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
Measured: Three months
glucose standard deviation
As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
Measured: Three months
glucose variance coefficient
As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
Measured: Three months
GMI-glucose management indicator
As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
Measured: Three months
time spent at the target glucose value (Time in range)
As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
Measured: Three months
Secondary outcomes (6)
rehospitalization/having surgery
rehospitalization/having surgery
Measured: Three months
wound site complications
wound site complications outcome will be collected from clinical data record
Measured: Three months
post-operative complications
bile leakage, delayed gastric emptying, pancreatic fistula, myocardial infarct, cardiac arrythmia, pneumonia, intraabdominal abscess, bleeding outcomes as complications will be collected from clinical data record
Measured: Three months
pain
Visual Analog Score for pain will be assessed. Pain will be assessed between 1-10 point; 1-no pian, 10-severe pain
Measured: Three months
quality of life-EORTC QOL-C30
Also quality of life of the patients will be assessed with European Organization for the Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQQ-C30) Version 3.0. All functional scales and individual item scores are transformed to a 0-100 scale with higher values indicating a higher functioning in functional scales and an increased presence of symptoms in symptom scales.
Dear reviewer, there EORTC have 5 functional scales (physical functioning, role. functioning, emotional functioning, cognitive functioning, social functioning), global health status sub-scale, 9 symptom scales (fatigue, nause and vomiting, pain, dsypnoea, insomnia, apptite loss, constipation, diarhoea, financial difficulties). If we give each subscale, so much secondary outcomes and confused will be. Therefore we can not give each subscale as secondary outcomes.
Measured: Three months
quality of life-PAN26
Quality of life of pancreas cancer aspect will be assessed with PAN26. All functional scales and individual item scores are transformed to a 0-100 scale with higher values indicating a higher functioning in functional scales and an increased presence of symptoms in symptom scales.
Dear reviewer, The QLQ-PAN26 consists of 15 sub-scales (pancreatic pain, bloating digestive symptoms, taste, indigestion, flatulence, weight loss, weakness arms and legs, dry mouth, hepatic symptoms, altered bowel habit, body image, taubled with side-effects, future worries and planning of activities) and 2 functional scales (satisfaction with health care, and sexuality). Because there are so many subsclaes, we prefer only PAN26 quality of lie aspect.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Apr 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study has a single-center, randomized, controlled, single-blind design. The study sample will include 40 patients (20 intervention group, 20 control group) with PD. The allocation ratio will be 1:1.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Yaprak S. Ordin, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774170
- Sponsor's protocol ID
- 223S838
- Other IDs
- TUBITAK
- Acronym
- FiGluR
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 23 Jan 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 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Structured Follow-up Intervention on Glucose Status After Pancreatic Cancer Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06774170
- Acronym / sponsor ID
- FiGluR / 223S838
- Conditions
- Pancreas Cancer, Diabetes
- Keywords
- pancreas cancer, pancreaticoduodenectomy, continuous glucose monitoring, type 3c diabetes mellitus, data mining
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 14 Jan 2025 (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 primary aim of the present study is to examine the effect of a "structured follow-up intervention" to be performed in the first three months after PD on blood glucose. The exploratory aim of the study is to examine the effect of the "structured follow-up intervention" to be performed in the first three months after PD on patient outcomes (mortality, rehospitalization and having surgery, wound site complications, bile leakage, delayed gastric emptying, pancreatic fistula, myocardial infarct, cardiac arythmia, pneumonia, intraabdominal abscess, bleeding and pain) and the quality of life. The secondary aim of the study is to evaluate the factors affecting glucose levels in three months after PD by using data mining. Data mining will allow evaluation of all the factors affecting glucose levels by using detailed blood glucose predictors obtained through continuous glucose monitoring after PD. The study has a single-center, randomized, controlled, single-blind design. The study sample will include 40 patients with PD. The allocation ratio will be 1:1. Since being diagnosed as diabetes before surgery is an important variable, block randomization will be performed depending on whether the patients have the diagnosis of diabetes.
Detailed description
The primary aim of the present study is to examine the effect of a "structured follow-up intervention" to be performed in the first three months after PD on blood glucose. The exploratory aim of the study is to examine the effect of the "structured follow-up intervention" to be performed in the first three months after PD on patient outcomes (mortality, rehospitalization and having surgery, wound site complications, bile leakage, delayed gastric emptying, pancreatic fistula, myocardial infarct, cardiac arythmia, pneumonia, intraabdominal abscess, bleeding and pain) and the quality of life. The secondary aim of the study is to evaluate the factors affecting glucose levels in three months after PD by using data mining. Data mining will allow evaluation of all the factors affecting glucose levels by using detailed blood glucose predictors obtained through continuous glucose monitoring after PD. The study has a single-center, randomized, controlled, single-blind design. The study sample will include 40 patients with PD. The allocation ratio will be 1:1. Since being diagnosed as diabetes before surgery is an important variable, block randomization will be performed depending on whether the patients have the diagnosis of diabetes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study has a single-center, randomized, controlled, single-blind design. The study sample will include 40 patients (20 intervention group, 20 control group) with PD. The allocation ratio will be 1:1.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: structured follow-up interventionStructured follow-up intervention will be performed |
| Control group | No intervention | –Routine post-operative follow-up and education will be applied. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The inclusion criteria for the particioants were; being over 18 years of age, being a smartphone user compatible with the Dexcom G6 application, having an internet connection, having a Mini Mental Test result of over 22 points for educated individuals and over 19 points for uneducated individuals, being willing to participate in the study, and having undergone pancreaticoduodenectomy.
- In the study, "able to swallow table" is not eligibility criteria due to tablet (medication) adherence is not assssed In the study, patients with and without preoperative diabetes mellitus type II were included in the sample. Block randomization was performed according to the presence of DM. Therefore, the presence of diabetes is not an exclusion criterion.
- In the literature, thyroid disease has not been identified as an exclusion criterion in studies related to pancreatogenic diabetes. The endocrinologist involved in this project did not find it necessary to add thyroid disease as an exclusion criterion.
Key exclusion criteria (1 listed)
- Exclusion criteria were; having developed sepsis after surgery, having been diagnosed with insulinoma, glycogonoma, ectopic ACTH syndrome before surgery, having been diagnosed with a psychiatric disease, clinical diagnosis of Alzheimer's Disease and being hospitalized.
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 |
|---|---|---|
| structured follow-up interventionThe intervention has been created in light of the studies including type 1 and type 2 diabetes patients and experiences of the project team with patients after PD. Theoretical background of the intervention is based on the interventions developed for glucose management in type 1 and type 2 diabetes patients and the effect of the intervention will be evaluated by using the "plan-do-check-act" model. | Behavioural | Intervention group |
Primary outcome
HbA1c
Time frame: Three months
HbA1c
fasting blood glucose
Time frame: Three months
fasting blood glucose
mean glucose
Time frame: Three months
As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
glucose standard deviation
Time frame: Three months
As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
glucose variance coefficient
Time frame: Three months
As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
GMI-glucose management indicator
Time frame: Three months
As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
time spent at the target glucose value (Time in range)
Time frame: Three months
As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
6 secondary outcomes
rehospitalization/having surgery
Time frame: Three months
wound site complications
Time frame: Three months
post-operative complications
Time frame: Three months
pain
Time frame: Three months
quality of life-EORTC QOL-C30
Time frame: Three months
quality of life-PAN26
Time frame: Three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Pancreas Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing structured follow-up intervention in people with Pancreas Cancer and Diabetes, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 3 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
HbA1c (time frame: Three months). The study lists 7 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 23 Jan 2025.