Continuous Real-Time Glucose Monitoring And Naive Subjects: An Evaluation on Expanded Access – The CRANE study
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0009345
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 66
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
8. Willingness to comply with the protocol
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
? Uncontrollable medical/psychiatric conditions that interfere with clinical trial-related procedures or visits, including ongoing treatment for serious malignancies, are expected to persist for a long period of time
? Those with other conditions determined by the investigator
6. Persons who have difficulty using medical devices for clinical trials due to allergies to medical adhesives, etc.
7. Those who meet one or more of the following conditions that may affect the stability of HbA1c measurement at the time of screening
? People with acute or chronic bleeding or bleeding disorders
? Those who have received a red blood cell transfusion or received erythropoietin within at least 3 months from the time of screening
? Those expected to receive red blood cell transfusion or erythropoietin during the clinical trial period
? Those with other conditions determined by the investigator
8. Those expected to use acute oral or injectable glucocorticoids that may affect glycemic control and HbA1c (e.g., steroid bursts frequently used for inflammatory arthritis or inflammatory bowel disease, recurrent lumbar epidural steroid injections), but , does not exclude stable use of glucocorticoids for the purpose of treating rheumatoid arthritis or Addison's disease, etc.)
9. Those currently taking hydroxyurea
10. Those whose 10-day reading data obtained from the Dexcom G6? CGMS and blinded G6 receiver provided at the time of screening were confirmed to be less than 70%
11. Those who are currently participating in another clinical trial or have participated in another clinical trial within 90 days of the screening date
12. In other cases, when the investigator determines that participation in the clinical trial is inappropriate because it may affect the results of the clinical trial or ethically.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c change
- Secondary Outcome Measures
Name Time Method Percentage change in Time in Range (TIR) within target blood glucose range (above 70 mg/dL and below 180 mg/dL);Change in percentage of time in each blood glucose range (Time above range, TAR and Time below range, TBR) outside of target blood glucose range;Change in daily average blood glucose, blood glucose variability, and standard deviation;CGM System Usage Rate;SMBG test frequency;DTSQs(Diabetes Treatment Satisfaction Questionnaire) DTSQc(Diabetes Treatment Satisfaction Questionnaire change version