Continuous Real-Time Glucose Monitoring And Naive Subjects: An Evaluation on Expanded Access – The CRANE study

Samsung Medical Center0 sites66 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

December 22, 2023

Last Updated

2 years ago

Study Type

Interventional Study

Sex

All

Sponsor

•1\. male or female 19 years of age or older
•2\. diagnosed with type 2 diabetes (T2D) at least 6 months prior to screening
•3\. using an insulin regimen that meets one of the following criteria for at least 3 months at the time of screening
•(1\) Multi\-dose insulin injection therapy alone or in combination with other diabetes medications
•Basal insulin injection therapy alone or in combination with other diabetes medications.
•4\. HbA1c test result of 7\.8% or greater and eGFR test result of 30 mL/min/1\.73 m2 or greater at screening.
•5\. Agree to perform self\-monitoring of blood glucose (SMBG) for the duration of the study according to the investigator's instructions.
•6\. If female of childbearing potential, agree to use at least one of the following clinically appropriate contraceptive methods\* for the duration of the study.
•\* Hormonal contraception, intrauterine device, tubal ligation, double barrier method (combination of barriers such as male condom, female condom, cervical cap, contraceptive septum, contraceptive sponge), single barrier method with spermicide
•7\. have voluntarily decided to participate in this study and have given written informed consent to the subject statement and consent form

•1\. Those who have experience using CGMS for at least 3 months at the time of screening (however, professional or blinded CGM and intermittent scanning CGM are not excluded)
•2\. Those whose BMI (body mass index) exceeds 45 kg/m2
•3\. Those who are expected to change the insulin delivery method or insulin formulation during the clinical trial period (however, if necessary according to the change in prescription, changes in the insulin formulation within the class are permitted, e.g. changing insulin lispro to insulin aspart)
•4\. Those who meet one or more of the following items related to weight loss or obesity surgery at the time of screening
•? Those who are currently using weight loss drugs (however, chronic use of weight loss drugs in people with stable weight is not excluded) or those who plan to use weight loss prescription drugs during the clinical trial period
•? Those who are participating in or plan to start a fasting program (e.g. protein\-sparing diet plans) during the clinical trial period
•? Those who have undergone obesity\-related surgery within at least one year from the time of screening or plan to undergo obesity surgery during the clinical trial period
•5\. At the time of screening, at the discretion of the investigator, one or more of the following applies and has a concomitant disease or condition that may threaten the subject's safety (or a person with a medical history)
•? Severe mental illness
•? Diagnosed or suspected eating disorder