Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Syndrome

Adenoma

Pituitary Diseases

Cushing Syndrome

Growth Hormone-Secreting Pituitary Adenoma

Pituitary Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Adrenocortical Hyperfunction

Adrenal Gland Diseases

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Cushing's Syndrome

Hyperadrenalism

All Drugs and Chemicals

Hormones

Patients newly diagnosed GH-releasing pituitary adenoma or Cushing Syndrome in our department will be monitored blood glucose by CGMS Gold.

continuous glucose monitoring

yiming li

Glucose fluctuations present not only in patients with diabetes mellitus but also in subjects with normal glucose tolerance or impaired glucose regulation. People with Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome are at risk of impaired glucose metabolism. Glycemic variability is poorly studied in the nondiabetic individuals. The aim of the study is to investigate the characteristics of glucose fluctuations in the newly diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome individuals.

Glucose fluctuations present not only in patients with diabetes mellitus but also in subjects with normal glucose tolerance or impaired glucose regulation. Compared with traditional monitoring methods, continuous glucose monitoring system(CGMS) techniques provides a much more detailed understanding of shifting blood glucose levels throughout the day.It is considered reliable to evaluate glucose variability not only in patients with diabetes but also in nondiabetic individuals.

People with Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome are at risk of impaired glucose metabolism and developing diabetes mellitus.Some researchers have shown that 15-30% Growth Hormone-Secreting Pituitary Adenoma are suffering from diabetes, 15-36% impaired glucose regulation. The rate of Cushing Syndrome individuals is 10-30% and 40-45% separately.

Glycemic variability is poorly studied in the nondiabetic individuals and has not been studied in the newly diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome individuals. In this study CGM was used to dynamically monitor patients being newly diagnosed with Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome.

Glycemic Fluctuations in Newly Diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome Subjects

Characteristics of Glycemic Fluctuations in Newly Diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome Subjects

The monitoring results consisted of one curve and 5 parameters

The mean amplitude of glycemic excursion of newly diagnosed GH adenoma patients during the 3 days monitored by CGMS Gold

The mean amplitude of glycemic excursion of newly diagnosed Cushing Syndrome patients during the 3 days monitored by CGMS Gold

By compared with the outcomes after treated by SSAs or surgery we want to get weather there is a correlation between MAGE and IGF-1 in GH adenoma patients

By compared with the outcomes after treated by surgery we want to get weather there is a correlation between MAGE and cortison in Cushing Syndrome patients

Huashan Hospital

Principal Investigator, Clinical Associate Professor of Endocrinology department

Nutritional and Metabolic Diseases

Immune System Diseases

Diabetes Mellitus

Diabetes Mellitus, Type 2

Diabetes Mellitus, Type 1

Hypoglycemia

Hyperglycemia

Metabolic Diseases

Glucose Metabolism Disorders

Autoimmune Diseases

Hypoglycemic Agents

Insulin

Insulin, Globin Zinc

The FreeStyle Libre 2 Flash Glucose Monitoring System (FSL2) is a CGM device with real time alarms capability indicated for the management of diabetes in persons aged 4 and older. The Sensor holds eight (8) hours of data at a time. In order to have a daily diary of the Glucose level the patients or family or HCP must read the sensor (with reader or app) at least every height (8) hours. Every day at least three (3) scans of the sensor should be performed using the reader or the Smartphone App, generally at wake up in the morning, in the afternoon and at the time to go to sleep.

The alarm system will be activated, so that the Glucose level is over the cut off limit of 180 mmol/L or when it is lower than the cut-off limit of 80 mmol/L, the patient and/or the family members and/or the caregiver will check the Glucose level by scanning the reader/smartphone over the sensor.

This arm will perform the usual standard routine for blood glucose monitoring in patients with insulin therapy, that is represented by at least three finger pricks/die according to the usual standards routine of each center.

Different frequency of finger pricks glucose measurements could be performed on the basis of health care professional patient assessment of each patient's needs.

FSL2 is an integrated continuous glucose monitoring (CGM) system that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts. It is composed by a sensor and a reader. The Sensor, to apply on the back of the arm, continuously measures glucose concentration in interstitial fluid and has an 8-hour memory capacity. The Sensor is factory calibrated, does not require finger stick calibration and can be worn for up to 14 days.

The reader is a small handheld device that monitors glucose values in real-time to provide alerts and alarms which, when enabled, warn the user of Low Glucose, High Glucose or Signal Loss and prompt the user to scan the Sensor.

The FSL 2 System is CE mark, it is commercially available and in the current study it is being used in accordance with approved labeling. No modifications of FSL2 System have been performed for the utilization in the current study.

Continuous Glucose Monitoring

The control group is represented by the usual standard way for blood glucose (BG) monitoring. The control group will use a lancing device for finger samples for collection of blood drop to be put in the test strips to be read in the Glucose meter. Lancing devices, lancets and test strips used in the comparison groups are CE marked and are used according to the user's instructions.

Monitoring and/or self-monitoring of blood glucose using glucose meters and test strips provides quantitative measurements of fingerstick blood glucose at a single point in time for patients and their healthcare providers to monitor the effectiveness of glycemic control and make more immediate treatment with the right dosage of insulin. The usual standard routine for blood glucose monitoring in patients with DM and with insulin therapy is represented by at least three finger pricks/die according to the usual standards routine of each center.

Standard Care

Cancer patients with known or newly diagnosed (i.e. iatrogenic) Diabetes Mellitus (DM) in Palliative/Supportive Care will be enrolled. Patients will be randomly assigned to one of two groups. Patients included in the first group will monitor glucose levels through Continuous Glucose Monitoring (CGM), using the FreeStyle Libre 2 (FSL2). The second group is represented by the usual standard way for blood glucose (BG) monitoring (lancing device for finger samples). An interim analysis is foreseen when the half of the expected events (hyperglycemic peaks) will be observed. In case the results of interim analysis show superiority of the CGM (FSL2) group patients of the second group will be switched.

Diabete Mellitus (DM) represents an emerging factor with an impact on the severity and the management of symptoms (pain, dyspnoea, fatigue, nausea, vomiting, dehydration) in PC/SC patients leading to a reduced QoL of patients and family members. It has been noted that infrequent Blood Glucose (BG) monitoring might result in a not clear definition about whether symptoms are associated with the dying process or caused by diabetes, leading to inadequate symptoms management.

It is estimated that more than 30% of PC/SC patients can be affected by DM type I or type II. The incidence of diabetes seems to be six times greater in cancer patients than in the general population.

Despite this high incidence, implementation of standard Guidelines on monitoring BG levels in the PC/SC setting is lacking and the existing Guidelines are mainly based on expert experience rather than real data obtained from well design studies as evidenced by a recent review. Currently, the available tool used to evaluate BG in PC/SC patients is mainly represented by the punctual finger-samples procedure, which is usually performed only when there is a suspect of hyperglycemia/hypoglycemia or routinely in PC patients with known DM before meals administration. Punctual finger-samples procedure has many limitations: it is uncomfortable and painful for patients, it requires training to patients and family members by Health Care Providers (HCPs) and requires time to HPCs for preparing/conducting the procedures. As a consequence, BG monitoring in PC/SC patients (especially in home care settings) with known DM and newly diagnosed DM is very poorly and infrequently performed and represents a real unmet medical need.

Recently, a very innovative device, Freestyle Libre 2 (FSL2) (Abbott), has obtained a CE mark for Continuous Glucose Monitoring (CGM) in diabetic patients. The system includes a self-applied sensor with a size of two-stacked quarters, that is easy to apply on the back of the upper arm; it employs a pre-calibrated sensor that measures the tissue glucose concentration repeatedly for two weeks and has a duration of accuracy measurements of 14 consecutive days; interstitial Glucose levels are easily check with a painless one-second scan by a smartphone App or a Reader with results represented by latest glucose concentration and trend direction. The scan with the App or the Reader should be applied at least every 8 hours in order to have the recording of the glucose level. FSL2 has real-time glucose alarms that notify if glucose level is going too low or too high (Free Style Libre 2 User's Manual).

The rationale of the proposed study is based on the CGM system using FSL2, that is highly matching the need of Glucose level monitoring in PC/SC patients with known or newly diagnosed (i.e. iatrogenic) DM. FSL2 has no/very little discomfort for patients and it is not painful, it is easy to apply, it is not time-spending for family members and HCPs and it requires very brief training for patients and family members. The alarm system of FSL2 can aware patients, family members and HCPs at any moment when the glucose level is over a predefined cut off value, allowing to implement the appropriate interventions (i.e. insulin administration or insulin dose adjustment) in order to prevent and manage Symptomatic hyperglycemia crisis. The recent International Consensus on Recommendations on CGM data interpretation are showing that in particularly frail population, Glucose level are maintained for 50% of the time in a range between 70 mg/dL and 180 mg/dL and for 50% of the time in a range between 180 mg/dl and 250 mg/dl. According to that Recommendations, the alarm could be activated when glucose is over a cut off level of 180 mg/dL. The alarm activation allows patients themselves, family members, HCPs to provide patients with the most appropriate intervention (i.e. administration or adjustment of insulin dosage) in order to prevent glucose level reaching the peak of severe hyperglycemia (\>250 mg/dl).

Similarly, FSL2 allows to monitor Glucose level decrease and to prevent severe hypoglycemic crisis (BG \<50 mg/dL).

On this basis, we would like to evaluate CGM by using FSL2 as a tool for appropriately managing Glucose levels in PC/SC advanced oncological patients with known or newly diagnosed DM in order to prevent severe hypoglycemic/hyperglycemic crisis, in comparison to the current usual procedures (finger samples procedures).

CGM by using FSL2 could have a very positive impact in improving glucose level management in the PC/SC setting, especially in the home care setting, contributing to an improvement of the QoL of patients/family members and the HCPs attitude to the importance of glucose level monitoring. The results of this study could lead to a new standard of care in the management of patients with advanced cancer with a known/newly diagnosed DM in PC/SC settings.

The study is a multicenter, multinational, randomized, open label, parallel groups study, conducted in order to show superiority of CGM by using FSL2 in comparison to usual care procedures (finger samples) in reducing severe hyperglycemic peaks in PC/SC advanced oncological patients with known/newly diagnosed DM.

An interim analysis is foreseen when the half of the expected events (hyperglycemic peaks) will be observed. In case the results of interim analysis show superiority of the CGM (FSL2) group in respect to the control group, patients of the control group will be switched to CGM by using FSL2 and will be followed until the completion of the study.

GLYPALCARE STUDY - Multicenter, Randomized Study for Evaluating Continuous Glucose Monitoring (CGM) by Using FreeStyle Libre 2 (FSL2) for Preventing Hyperglycemia/Hypoglycemia Crisis in Advanced Oncological Patients.

GLYPALCARE STUDY - Multicenter, Randomized Study for Evaluating Continuous Glucose Monitoring (CGM) by Using FreeStyle Libre 2 (FSL2) for Preventing Hyperglycemia/Hypoglycemia Crisis in Advanced Oncological Patients With Known/Newly Diagnosed Type I/Type II Diabetes Mellitus (DM) in Palliative Care/ Supportive Care (PC/SC) Setting.

First severe hyperglycemic peak (\>250 mg/dL) observed during evaluation

Abbott Diabetes Care

Antea Foundation

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Study subjects submitted to the General Surgery Clinic for colorectal surgery. On admission day, patients will have a CGM sensor placed on the outer part of the upper arm. Patients will undergo standard surgical procedures and perioperative care. Glycemia will be continuously monitored for 10 days. The CGM sensor will be taken off during visit in Outpatient Clinic.

FreeStyle Libre 3 system consists of a sensor that measures interstitial glycemia every minute and a dedicated application on mobile phone. Measurements are transmitted via Bluetooth to a mobile phone, that collects the data in the mobile application. Moreover, the study subject's application is connected to the doctor's application which allows remote real-time glycemia monitoring on another device.

Other Name: continuous glucose monitoring, CGM, FreeStyle Libre 3

CGM (FreeStyle Libre 3)

Magdalena Antoszewska, MD

Piotr Spychalski, MD, PhD

Jarosław Kobiela, Prof.

Hyperglycemia commonly occurs during surgery due to a reaction to metabolic stress and trauma. It has been shown that improper glycemia control leads to impaired wound healing and a higher risk of other postoperative complications.

The primary aim of our project is to assess the feasibility of the use of continuous glucose monitoring in measuring blood glucose levels in patients undergoing colorectal cancer surgery. The secondary aim is to analyze changes in perioperative blood glucose levels to understand the effects of stress and intraoperative interventions on the blood glucose level. The tertiary goal is to assess the predictive value of hyperglycemia for surgical site infection.

Hyperglycemia commonly occurs during surgery due to a reaction to metabolic stress and trauma. It has been shown that improper glycemia control leads to impaired wound healing and a higher risk of other postoperative complications. However, glucose levels measured in patients before surgery are taken infrequently, and there remains controversy regarding optimal management. Usually, a blood glucose meter is used to measure non-fasted blood glucose concentrations, and a single-point measurement can easily misrepresent the actual glycemic control. Continuous glucose monitoring allows for a minimally invasive real-time remote glycemia control and is providing insights into glucose regulation in patients, demonstrating significant periods of clinically silent hypoglycemia and hyperglycemia.

The primary aim of our project is to assess the feasibility of the use of CGM in measuring blood glucose levels in patients undergoing colorectal cancer surgery. The secondary aim is to analyze changes in perioperative blood glucose levels to understand the effects of stress and intraoperative interventions on the blood glucose level. The tertiary goal is to assess the predictive value of hyperglycemia for surgical site infection.

Continuous Glucose Monitoring for Colorectal Cancer

measured as the drop-out rate caused by non-adherence of both patients and medical staff due to system detaching, problems with the receiving device (low battery. distance beyond Bluetooth communication range) etc.

number of hyperglycemia episodes impact of stress and intraoperative interventions on the blood glucose level

Surgical Site Infection according to Centre for Disease Control criteria:

Infection occurring within the first 30 post-operative days with at least one of the following:

Purulent drainage from the incision Organisms isolated from an aseptically obtained culture of fluid or tissue from the incision

Incision is deliberately opened by a surgeon AND at least one of the following signs/symptoms of infection:

Pain or tenderness Localized swelling Redness Heat Diagnosis of SSI by the surgeon or attending physician

Medical University of Gdansk

Pancreatic Neoplasms

Pancreatic Diseases

Pancreatic Cancer

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.

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.

Participants will wear continuous glucose monitors for a 7 day period.

Continuous glucose monitors

Participants will wear the activity tracker for a 7 day period.

Activity tracker

Participants will complete a food diary of everything they eat for 7 days.

Food Diary

Participants will complete FACT-Hep, DiPcare-Q and health inequality related questions.

Questionnaires

Elizabeth Wrench

Christopher J Gaffney

Research and Development

Sarah Ashton

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.

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.

A Case-control Study Comparing Glycaemic Control in Pancreatic Cancer Patients vs Healthy Matched Individuals.

A Case-control Study Comparing Glycaemic Control in Pancreatic Cancer Patients Versus Age Matched Healthy Individuals Using Continuous Glucose Monitors.

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, 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Glycemic Fluctuations in Newly Diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome Subjects	NCT02574793	Pituitary Adeno...	continuous gluc...	-	Huashan Hospital
GLYPALCARE STUDY - Multicenter, Randomized Study for Evaluating Continuous Glucose Monitoring (CGM) by Using FreeStyle Libre 2 (FSL2) for Preventing Hyperglycemia/Hypoglycemia Crisis in Advanced Oncological Patients.	NCT04942756	Palliative Care Diabetes Mellit... Diabetes Mellit... Diabetes Cancer Terminal Cancer Terminal Illnes... End Stage Cance... Advanced Cancer	Continuous Gluc... Standard Care	18 Years -	Antea Foundation
Continuous Glucose Monitoring for Colorectal Cancer	NCT06011473	Continuous Gluc... Colorectal Canc...	CGM (FreeStyle ...	18 Years -	Medical University of Gdansk
A Case-control Study Comparing Glycaemic Control in Pancreatic Cancer Patients vs Healthy Matched Individuals.	NCT05583890	Pancreatic Canc...	Continuous gluc... Activity tracke... Food Diary Questionnaires	18 Years - 85 Years	Lancaster University
A Case-control Study Comparing Glycaemic Control in Pancreatic Cancer Patients vs Healthy Matched Individuals.	NCT05583890	Pancreatic Canc...	Continuous gluc... Activity tracke... Food Diary Questionnaires	18 Years - 85 Years	Lancaster University

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