Diabetes, Pancreas Cancer
Conditions
Keywords
pancreas cancer, pancreaticoduodenectomy, continuous glucose monitoring, type 3c diabetes mellitus, data mining
Brief 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 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.
Interventions
BEHAVIORALstructured follow-up intervention
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.
Sponsors
The Scientific and Technological Research Council of Turkey
Dokuz Eylul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Participants do not know which group they are in. Both groups are included in the study in parallel. Both groups will be monitored continuously with a glucose device. The researcher will allocate equal time to both groups. Both groups will be called with the same frequency and the same time will be allocated for these interviews. The control group will receive routine post-operative training. The follow-up intervention initiative developed will be applied to the intervention group.
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time spent at the target glucose value (Time in range) | 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 | 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. |
| HbA1c | Three months | HbA1c |
| fasting blood glucose | Three months | fasting blood glucose |
| mean glucose | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| wound site complications | Three months | wound site complications outcome will be collected from clinical data record |
| post-operative complications | Three months | 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 |
| pain | Three months | Visual Analog Score for pain will be assessed. Pain will be assessed between 1-10 point; 1-no pian, 10-severe pain |
| quality of life-EORTC QOL-C30 | Three months | 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. |
| quality of life-PAN26 | Three months | 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. |
| rehospitalization/having surgery | Three months | rehospitalization/having surgery |
Countries
Turkey (Türkiye)
Outcome results
None listed