Diabetes (DM)NCT07889375
RIGHTEST iFree 2 CGM System for Glycemic Control in Adults With Diabetes Mellitus
A study testing Continuous Glucose Monitoring (CGM) and Self-monitoring of blood glucose (SMBG) in people with Diabetes (DM), run by Bionime Corporation at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes (DM)
- What is being tested?
- Continuous Glucose Monitoring (CGM) and Self-monitoring of blood glucose (SMBG)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 May 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥18 years of age at the time of enrollment.
- Subject has a confirmed diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) for ≥1 year.
- Subject has an HbA1c between 7.5% and 12.0% at screening.
- 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.
Show all 13Show fewer
- Subject is willing to comply with all study procedures, including CGM wear during the run-in period and follow-up visits.
- 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.
- Subject is able to read, understand, and write in Mandarin.
- Subject is willing and able to provide signed written informed consent prior to any study-related procedures.
- 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.
- Subject remains eligible per investigator's judgment, with no significant change in medical condition or diabetes treatment since screening that would preclude participation.
- Subject remains willing to comply with randomization to CGM (intervention) or SMBG (control) and complete the 24-week follow-up period.
Who cannot join
- Known allergy or intolerance to medical-grade adhesive tape.
- 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).
- Female subjects who are pregnant, planning to become pregnant, or breastfeeding during the study period.
- Currently receiving or planning to receive dialysis during the study.
- eGFR < 30 mL/min/1.73 m².
- Current use of, or planned use during the study, of any real-time CGM (rtCGM) or intermittently scanned CGM (isCGM) device.
Show all 13Show fewer
- History of severe hypoglycemia (requiring third-party assistance) or diabetic ketoacidosis (DKA) within 6 months prior to screening.
- Anticipated or planned acute use of glucocorticoids (oral, injectable, inhaled, or intravenous) that may affect glycemic control or HbA1c.
- Any condition that may affect the accuracy of HbA1c measurement within 3 months prior to screening (e.g., recent blood transfusion, erythropoietin therapy, hemoglobinopathies).
- Implanted cardiac devices such as pacemakers or implantable cardioverter-defibrillators (ICD).
- 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.
- Severe psychiatric illness, substance abuse, or other conditions likely to impair adherence.
- Any other condition that, in the opinion of the Investigator, makes the subject unsuitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Hung-Yuan Li, MD, PhD, +886-02-23123456 ext. 263540, larsli@ntuh.gov.tw
About this study
Official title: An Open-label, Multicenter, Randomized, Parallel-group Trial to Assess Glycemic Control With the RIGHTEST iFree 2 Continuous Glucose Monitoring System in Adults With Diabetes Mellitus
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:
Read more
- 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.
- Conditions
- Diabetes (DM)
- Being tested
- Continuous Glucose Monitoring (CGM), Self-monitoring of blood glucose (SMBG)
- Keywords
- continuous glucose monitoring, self-monitoring of blood glucose, glycemic control
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring (CGM)Device
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.
Self-monitoring of blood glucose (SMBG)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| CGM | Experimental | Not described Receives: Device: Continuous Glucose Monitoring (CGM) |
| SMBG | Active comparator | Not described Receives: Device: Self-monitoring of blood glucose (SMBG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycated hemoglobin (HbA1c) from baseline to Week 24
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.
Measured: Baseline and 24 weeks after randomization (end of treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start15 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bionime Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889375
- Sponsor's protocol ID
- TW-510-R01
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Randomized, Parallel-group Trial to Assess Glycemic Control With the RIGHTEST iFree 2 Continuous Glucose Monitoring System in Adults With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07889375
- Acronym / sponsor ID
- TW-510-R01
- Conditions
- Diabetes (DM)
- Keywords
- continuous glucose monitoring, self-monitoring of blood glucose, glycemic control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Bionime CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM | Experimental | Device: Continuous Glucose Monitoring (CGM) |
| SMBG | Active comparator | Device: Self-monitoring of blood glucose (SMBG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject is ≥18 years of age at the time of enrollment.
- Subject has a confirmed diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) for ≥1 year.
- Subject has an HbA1c between 7.5% and 12.0% at screening.
- 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.
Key exclusion criteria (13 listed)
- Known allergy or intolerance to medical-grade adhesive tape.
- 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).
- Female subjects who are pregnant, planning to become pregnant, or breastfeeding during the study period.
- Currently receiving or planning to receive dialysis during the study.
- eGFR < 30 mL/min/1.73 m².
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous 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. | Device | CGM |
| Self-monitoring of blood glucose (SMBG)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. | Device | SMBG |
Primary outcome
Change in glycated hemoglobin (HbA1c) from baseline to Week 24
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes (DM)
Active, not recruiting
Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City
Blood Cholesterol, Blood Pressure Monitoring
Not yet recruitingPhase 2
Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.
Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)
Recruiting
Changes in Person-reported Outcomes and Behavior Using the Accu-Chek SmartGuide CGM and Predict App
Diabetes (DM), Diabetes Mellitus
Not yet recruitingPhase 2
Tolerability and Safety of Nano-Tocotrienols
Type 2 Diabetes Mellitus (DM)
Not yet recruitingEarly Phase 1
Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health (Healthy Heart - CKM)
Hypertension (HTN), Diabetes (DM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitoring (CGM) and Self-monitoring of blood glucose (SMBG) in people with Diabetes (DM), run by Bionime Corporation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joy CRA, MA (+886-4-23692388 ext. 5875, Joy.chen@bionime.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycated hemoglobin (HbA1c) from baseline to Week 24 (time frame: Baseline and 24 weeks after randomization (end of treatment period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.