Effectiveness and Safety of the RIGHTEST™ Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus

December 26, 2023 updated by: Bionime Corporation

The trial is expected to enroll 120 confirmed cases of type 1 or type 2 diabetes. All eligible subjects must wear a continuous glucose monitoring system on both the left and right upper arms for a maximum of 15 days (360 hours) and adhere to the clinical visit protocol. The entire trial process consists of pre-screening visits, 5 clinical visits, and 1 telephone follow-up.

After enrollment, all subjects will be randomly assigned to either Group A or Group B to determine the time points for clinical visits. Group A subjects will have venous blood drawn on days 1 and 10 (±1) post-wearing, while Group B subjects will have venous blood drawn on days 5 (±1) and 15 (-1) post-wearing. All subjects will remove all devices on day 15 (-1) based on system prompts and undergo a telephone follow-up on day 4 (±3) thereafter. This clinical trial does not involve long-term follow-up.

During the trial, the blood glucose values measured by the "continuous glucose monitoring system" worn by the subjects will be analyzed against the EKF venous blood glucose values measured at the medical institution on days 1, 5 (±1), 10 (±1), and 15 (-1) as control reference values. This analysis aims to evaluate the accuracy, repeatability, stability, high and low blood glucose event alerts, and safety of the continuous glucose monitoring system.

Additionally, fingertip blood glucose measurements taken by subjects during home use will be collected to assess the operational feasibility of the continuous glucose monitoring system in a home setting.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants are aged 18 to 80 years old.
  2. Participants have been diagnosed with type 1 or type 2 diabetes.

  3. Participants must meet one of the following treatment criteria:

    • Daily insulin injections and/or insulin pump therapy at least once a day.
    • Use of antidiabetic medications, with glycated hemoglobin (HbA1c) not less than 8%. Relevant medications include but are not limited to: sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase 4 inhibitors, sodium-glucose cotransporter-2 inhibitors, and glucagon-like peptide 1 receptor agonists (GLP-1RAs).
  4. Participants who can comply with the experimental procedures and related requirements specified in the protocol.
  5. Volunteers willing to participate in this trial and who have signed the informed consent form.

Exclusion Criteria:

  1. Known allergy to disinfectant alcohol or medical-grade skin patches.
  2. Presence of skin trauma, infection, or skin disease at the site where the trial device is to be worn.
  3. Hemoglobin levels less than 90.0g/L.
  4. Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2.
  5. Use of other implanted medical devices, such as pacemakers or defibrillators.
  6. Acutely critically ill patients.
  7. Patients with active infectious diseases.
  8. Requirement for imaging examinations, phototherapy, or thermotherapy during the wearing period.
  9. History of unconscious hypoglycemia in the six months preceding the trial; patients admitted to the hospital at screening are excluded.
  10. Pregnant women or women planning to become pregnant during the study.
  11. Inability to read the product instructions or inability to wear the trial device after receiving education and training.
  12. Participation in another clinical trial within the two weeks prior to screening.
  13. Other situations determined by the investigator as unsuitable for participation in this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: DM self-control group
Device: Device implant
subcutaneous device implanting

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
accuracy
Time Frame: 15 day
The percentage of the CGM System raw readings within ±20/20%of paired reference measurements across the device measuring range overall are evaluated.
15 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bionime Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CN-312-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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