Diabetes MellitusNCT04838392
Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus
A study testing RIGHTEST Continuous Glucose Monitoring System in people with Diabetes Mellitus and Type 1 Diabetes, run by Bionime Corporation at 13 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of the RIGHTEST Continuous Monitoring (CGM) System in adult population with diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- RIGHTEST Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 13 sitesUnited States
- Study dates
- Dec 2024to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subjects must be 18 years and older
- Subjects must have a diagnosis of type 1 or type 2 diabetes mellitus
- Subjects must be available to participate in all clinical sessions with the following parameters:
- Subject must be willing to wear 1 sensor on each upper arm simultaneously.
- Subjects must be willing to have their glucose levels manipulated in each in-clinic visit.
- Subjects must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
- Subjects must be willing and able to provide signed written consent.
- Subjects must be able to speak, read and write English.
Who cannot join
- Known allergy and not able to tolerate to medical grade tape adhesive.
- Presence and unresolved of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin
- Subjects who have or are female of child-bearing potential age:
- Has a positive pregnancy screening test
- That plans to become pregnant during the course of study.
- Diagnosed with hemophilia or any other bleeding disorders
Show all 23Show fewer
- Acute or chronic kidney disease
- Currently managed by dialysis or anticipating initiating dialysis during the course of study.
- Current or know history of coronary artery or cardiovascular disease that is not stable with medical management thromboembolic disease.
- Any condition that, in the opinion of the Investigator, would interfere with their participation in the study or pose excessive risk to study staff.
- Prior to enrollment, subject has had:
- Severe hypoglycemia within past 6 months.
- History of Diabetic Ketoacidosis (DKA) within the past 6 months,
- History of a seizure disorder within the last 6 month
- Hypoglycemia unawareness.
- Severe diabetes related complications.
- Required or scheduled to have a Magnetic Resonance Imagining (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period.
- Plans to donate blood during the course of the study
- Insulin-dependent type 2 subjects that receive sodium-glucose cotransporter 2 inhibitor (SGLT2 inhibitor) treatment[14]
- Hematocrit (Hct) level lower than the normal reference range
- Weight less than 110 pounds (50 kg)
- Participated in another clinical trial within 2 weeks prior to screening
- Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Hope Clinical Research LLC
Canoga Park, California, 91303
AMCR Institute
Escondido, California, 92029
The Research Center of the Upstate
Greenville, South Carolina, 29607
Lakeview Clinical Research
Guntersville, Alabama, 35951
Scott Research,Inc
Laurelton, New York, 11413
L-MARC Research Center
Louisville, Kentucky, 40213
Infinite Clinical Trials
Morrow, Georgia, 30274
Research Integrity, LLC.
Owensboro, Kentucky, 42303
Oregon Health
Portland, Oregon, 97239
Novak Clinical Research
Tucson, Arizona, 85741
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
About this study
The purpose of this study is to evaluate the effectiveness and safety of the RIGHTEST Continuous Monitoring (CGM) System in adult population with diabetes mellitus.
Read the detailed description
This is a prospective, open-label, randomized, multicenter, single-arm pivotal study without control groups in up to 150 adult subjects with type 1 or type 2 diabetes mellitus who will be enrolled at 12 investigational sites in the United States.
All subjects are required to wear 1 Sensor on the back of each upper arm for up to 15 days (up to 360 hours) and participate in 4 in-clinic visits. All subjects will have frequent venous blood draws to evaluate the blood glucose reference measurements in each in-clinic visit and collect accurate information against a laboratory reference method.
- Conditions
- Diabetes Mellitus, Type 1 Diabetes, Type 2 Diabetes
- Being tested
- RIGHTEST Continuous Glucose Monitoring System
- Keywords
- Continuous Glucose Monitoring
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIGHTEST Continuous Glucose Monitoring SystemDevice
RIGHTEST Continuous Glucose Monitoring System
| Study group | Role | What they receive |
|---|---|---|
| CGM System | Experimental | Blood draw and glucose challenge will be performed to evaluate the performance of the CGM system compared to reference measurements during the in in-clinic visits. Receives: Device: RIGHTEST Continuous Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
RIGHTEST Continuous Glucose Monitoring System Performance
The CGM System performance will be primarily evaluated in terms of point and trend accuracy of RIGHTEST™ CGM System continuous interstitial glucose measurements compared to the reference method.
Measured: 15 days
Secondary outcomes (1)
To investigate the RIGHTEST Glucose Monitoring System other system performance and safety
The secondary objective is to investigate other system performance by comparing the CGM System readings to the reference method. System performance includes the point and the trend accuracy, the precision of the CGM system, the stability of the CGM system across the wear period, and the glucose event alert function. The safety of RIGHTEST CGM will be examined through the number and percentage of subjects experiencing adverse events and examined through symptoms related to the Sensor insertion site.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study startDec 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 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
- NCT04838392
- Sponsor's protocol ID
- US-312-01
- Status last verified
- Jul 2024
- First submitted
- 29 Mar 2021
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04838392
- Acronym / sponsor ID
- US-312-01
- Conditions
- Diabetes Mellitus, Type 1 Diabetes, Type 2 Diabetes
- Keywords
- Continuous Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bionime CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 9 Apr 2021 (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 purpose of this study is to evaluate the effectiveness and safety of the RIGHTEST Continuous Monitoring (CGM) System in adult population with diabetes mellitus.
Detailed description
This is a prospective, open-label, randomized, multicenter, single-arm pivotal study without control groups in up to 150 adult subjects with type 1 or type 2 diabetes mellitus who will be enrolled at 12 investigational sites in the United States.
All subjects are required to wear 1 Sensor on the back of each upper arm for up to 15 days (up to 360 hours) and participate in 4 in-clinic visits. All subjects will have frequent venous blood draws to evaluate the blood glucose reference measurements in each in-clinic visit and collect accurate information against a laboratory reference method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM System | Experimental | Device: RIGHTEST Continuous Glucose Monitoring SystemBlood draw and glucose challenge will be performed to evaluate the performance of the CGM system compared to reference measurements during the in in-clinic visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must be 18 years and older
- Subjects must have a diagnosis of type 1 or type 2 diabetes mellitus
- Subjects must be available to participate in all clinical sessions with the following parameters:
- Subject must be willing to wear 1 sensor on each upper arm simultaneously.
- Subjects must be willing to have their glucose levels manipulated in each in-clinic visit.
Key exclusion criteria (23 listed)
- Known allergy and not able to tolerate to medical grade tape adhesive.
- Presence and unresolved of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin
- Subjects who have or are female of child-bearing potential age:
- Diagnosed with hemophilia or any other bleeding disorders
- Acute or chronic kidney disease
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 |
|---|---|---|
| RIGHTEST Continuous Glucose Monitoring SystemRIGHTEST Continuous Glucose Monitoring System | Device | CGM System |
Primary outcome
RIGHTEST Continuous Glucose Monitoring System Performance
Time frame: 15 days
The CGM System performance will be primarily evaluated in terms of point and trend accuracy of RIGHTEST™ CGM System continuous interstitial glucose measurements compared to the reference method.
1 secondary outcome
To investigate the RIGHTEST Glucose Monitoring System other system performance and safety
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIGHTEST Continuous Glucose Monitoring System in people with Diabetes Mellitus and Type 1 Diabetes, run by Bionime Corporation at 13 sites in United States.
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 8 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RIGHTEST Continuous Glucose Monitoring System Performance (time frame: 15 days). 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 1 Aug 2024.