Diabetes (DM)
Conditions
Keywords
continuous glucose monitoring, self-monitoring of blood glucose, glycemic control
Brief summary
The goal of this clinical trial is to find out whether using a real-time continuous glucose monitoring (CGM) system can improve daily blood sugar control compared with usual self-monitoring of blood glucose (SMBG; finger-stick testing) in people with diabetes who are treated with insulin. This study will include adults with type 1 or type 2 diabetes who have less-than-ideal blood sugar control while using insulin. The main questions it aims to answer are: * Does CGM-guided diabetes management lead to a larger decrease in HbA1c from baseline to about 6 months than SMBG-guided management? * Does CGM use increase the time that glucose stays in the target range and reduce low blood sugar episodes, without causing new safety problems? Researchers will compare two groups. One group will use the RIGHTEST iFree 2 CGM system together with a smartphone app to view glucose data in real time. The other group will use standard finger-stick blood glucose monitoring with an approved blood glucose meter as their main tool for checking glucose. Both groups will continue to receive routine diabetes care from their usual health-care providers. Participants will take part in regular clinic visits over approximately 6 months. At these visits, study staff will review glucose records, adjust diabetes treatment if needed, and collect information such as HbA1c and other blood tests, device data, and questionnaires about quality of life and diabetes-related distress. Safety information and any device problems will also be recorded. The results will help determine whether CGM can be used as a routine tool to improve long-term blood sugar control in people with diabetes.
Interventions
DEVICEContinuous Glucose Monitoring (CGM)
Participants assigned to this arm will use a continuous glucose monitoring (CGM) system as the main tool for day-to-day glucose management. The system consists of a disposable subcutaneous glucose sensor, a reusable transmitter, and the RIGHTEST iFree 2 smartphone application for real-time data display and alerts. Sensors are worn continuously and replaced according to the product labeling over the \~6-month study period. CGM data will be reviewed by participants and study clinicians to guide self-management and diabetes treatment adjustments in addition to usual care.
Participants assigned to this arm will use self-monitoring of blood glucose (SMBG) with a capillary finger-stick blood glucose meter as their primary tool for day-to-day diabetes management. An approved meter (e.g., RIGHTEST Max Plus blood glucose meter) and test strips will be provided, together with training on correct use and recording of results. Participants will measure their blood glucose at a frequency consistent with routine diabetes care and the recommendations of their treating physician (for example before meals, at bedtime, and as clinically indicated). SMBG values and downloaded meter records will be reviewed at study visits to guide insulin and other diabetes treatment adjustments. No real-time continuous glucose monitoring data will be used in this arm.
Sponsors
Bionime Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥18 years of age at the time of enrollment. 2. Subject has a confirmed diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) for ≥1 year. 3. Subject has an HbA1c between 7.5% and 12.0% at screening. 4. Insulin therapy requirements by cohort: 4.1 T1DM: On multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) for ≥3 months prior to screening, with no major adjustments in insulin dose or regimen within 8 weeks before screening. 4.2 T2DM: On insulin therapy for ≥3 months prior to screening, defined as one of the following regimen classes: (a) Basal-only, (b) MDI (basal + ≥2 prandial injections/day), (c) CSII, or (d) Premixed insulin (≥2 injections/day); with no switch across insulin regimen classes and no major insulin-dose adjustments within 8 weeks before screening. 5. Subject is willing to comply with all study procedures, including CGM wear during the run-in period and follow-up visits. 6. Subject has access to and is able to use a compatible smartphone (if required by the CGM system) and is willing to install and use the study application. 7. Subject is able to read, understand, and write in Mandarin. 8. Subject is willing and able to provide signed written informed consent prior to any study-related procedures. 9. Subject has successfully completed the blinded CGM run-in period of at least 14 days (target 15 days) with ≥70% valid sensor wear time prior to randomization. 10. Subject remains eligible per investigator's judgment, with no significant change in medical condition or diabetes treatment since screening that would preclude participation. 11. Subject remains willing to comply with randomization to CGM (intervention) or SMBG (control) and complete the 24-week follow-up period.
Exclusion criteria
1. Known allergy or intolerance to medical-grade adhesive tape. 2. Presence of unresolved, extensive skin changes/diseases at potential sensor wear sites that would preclude sensor placement (e.g., psoriasis, severe eczema, scarring, tattoos, burns, or dermatitis herpetiformis). 3. Female subjects who are pregnant, planning to become pregnant, or breastfeeding during the study period. 4. Currently receiving or planning to receive dialysis during the study. 5. eGFR \< 30 mL/min/1.73 m². 6. Current use of, or planned use during the study, of any real-time CGM (rtCGM) or intermittently scanned CGM (isCGM) device. 7. History of severe hypoglycemia (requiring third-party assistance) or diabetic ketoacidosis (DKA) within 6 months prior to screening. 8. Anticipated or planned acute use of glucocorticoids (oral, injectable, inhaled, or intravenous) that may affect glycemic control or HbA1c. 9. Any condition that may affect the accuracy of HbA1c measurement within 3 months prior to screening (e.g., recent blood transfusion, erythropoietin therapy, hemoglobinopathies). 10. Implanted cardiac devices such as pacemakers or implantable cardioverter-defibrillators (ICD). 11. Critically ill subjects, or those with medical or psychiatric conditions that, in the opinion of the Investigator, may pose a risk to participation or interfere with compliance. 12. Severe psychiatric illness, substance abuse, or other conditions likely to impair adherence. 13. Any other condition that, in the opinion of the Investigator, makes the subject unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycated hemoglobin (HbA1c) from baseline to Week 24 | Baseline and 24 weeks after randomization (end of treatment period) | HbA1c (%) will be measured at baseline and at Week 24 using a central laboratory assay. Change in HbA1c is defined as the Week 24 value minus the baseline value. The primary analysis will compare the mean change in HbA1c between the CGM group and SMBG group, analyzed separately for adults with type 1 and type 2 diabetes, using an ANCOVA model adjusted for baseline HbA1c and other prespecified covariates. |
Countries
Taiwan
Contacts
CONTACTJoy CRA, MA
Outcome results
None listed