Clinical Trials Logo

Clinical Trial Summary

Researchers are looking for a better way to help Chinese people who have diabetes to monitor their blood sugar situation. There are 2 types of diabetes. In people with type 1 diabetes, the body's immune system attacks and destroys cells in the pancreas that produce a hormone called insulin. In people with type 2 diabetes, the body does not make enough insulin or does not use insulin well. This results in high blood sugar (glucose) levels. Over time, high blood sugar levels can cause damage to certain parts of the body. These include the eyes, the kidneys, the nerves, and the heart. There are tests and devices available for doctors and patients to measure blood sugar levels. In order to see if the diabetes treatment is workable to stabilize the blood sugar level, repeated blood sugar measurement is always needed. Such tracking of the blood sugar is also called blood sugar monitoring. Blood sugar monitoring tests and devices can however be difficult to use and one test or device may not work for all patients. Researchers think that better monitoring systems would help patients improve the control of their blood sugar levels. This could help to stabilize their blood sugar condition. In this study, the researchers want to learn more about how well a new monitoring system called Cascade works in Chinese patients with diabetes. Cascade is a continuous glucose monitoring system. It regularly measures the level of glucose in the tissue throughout the day and night. Cascade is made up of a small sensor that patients apply in the belly region where it is placed just under the skin, into the so-called subcutaneous tissue. The sensor measures the level of glucose in the fluid that surrounds cells in the subcutaneous tissue. It also has a transmitter which attaches to the sensor and sends the results via Bluetooth to a smart device, which can instantly display the glucose level. The glucose level can then be used to adjust the treatment. The main purpose of this study is to learn how well Cascade monitors glucose levels in Chinese patients when used in usual practice. To answer this question, the researchers will compare the glucose levels collected with the Cascade monitor to the blood sugar levels collected with venous blood glucose testing. This is where a blood sample is taken from the veins, and then the level of sugar in the blood sample is measured. The study will include adult Chinese patients who have type 1 or type 2 diabetes and who the study doctors think need to monitor their diabetes using Cascade and venous blood glucose testing. There will be no study treatments given as part of this study. The patients will be in the study for up to 18 days. The device will be worn up to a maximum of 14 days. The total duration of the study will be about 4 months. The patients will get training on how to use the Cascade monitor and will attach it to their belly area on Day 1 of the study. The patients will wear Cascade for up to 14 days. The researchers will then collect the information about their glucose levels. The study doctors will also take blood samples and measure blood sugar levels using venous blood glucose testing. They will compare the sugar levels recorded from the blood samples to the glucose levels recorded by Cascade at the closest time points. After wearing Cascade for 14 days, the study doctors will remove it from the patients' bellies. About 3 days later, the researchers will call the patients to check for any discomfort that has happened after the removal of the Cascade device. The patients may also take photos of the area and send these to the study doctors. During the study, the study staff will: - take blood samples as part of the usual care - compare glucose levels recorded by Cascade to the levels recorded from the venous blood glucose tests - check the skin for any swelling or areas of rash where Cascade was worn • record any instances of Cascade errors or malfunctioning - record any alarms for when glucose levels are too high or too low - check the patients' overall health - ask the patients about how they are feeling and what medical problems they are having.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05038761
Study type Observational
Source Bayer
Contact Bayer Clinical Trials Contact
Phone (+)1-888-84 22937
Email [email protected]
Status Not yet recruiting
Phase
Start date October 8, 2021
Completion date March 4, 2022

See also
  Status Clinical Trial Phase
Completed NCT03743779 - Mastering Diabetes Pilot Study
Completed NCT03786978 - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus N/A
Completed NCT01804803 - DIgital Assisted MONitoring for DiabeteS - I N/A
Recruiting NCT05039970 - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program N/A
Recruiting NCT04068272 - Safety of Bosentan in Type II Diabetic Patients Phase 1
Completed NCT03243383 - Readmission Prevention Pilot Trial in Diabetes Patients N/A
Recruiting NCT02690467 - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm. N/A
Completed NCT02229383 - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus Phase 3
Recruiting NCT04489043 - Exercise, Prediabetes and Diabetes After Renal Transplantation. N/A
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Completed NCT03542084 - Endocrinology Auto-Triggered e-Consults N/A
Completed NCT02229396 - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo Phase 3
Not yet recruiting NCT04125784 - Lipid Profile and Diabetes Mellitus in People With HIV
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A
Recruiting NCT03462420 - Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes N/A
Active, not recruiting NCT03607617 - ASCEND: ApproacheS to CHC ImplEmeNtation of SDH Data Collection and Action
Recruiting NCT04687215 - Diabetic Neuropathy in Spinal Cord Stimulator Patients
Not yet recruiting NCT04526613 - The Influence of Malnutrition, Diabetes Mellitus, and Helminth Infections on Biosignatures in Latent Tuberculosis in a South Indian Population
Terminated NCT03285308 - A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01 Phase 3