Status:
UNKNOWN
Effectiveness and Safety of the RIGHTEST™ Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus
Lead Sponsor:
Bionime Corporation
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 max...
Eligibility Criteria
Inclusion
- Participants are aged 18 to 80 years old.
- Participants have been diagnosed with type 1 or type 2 diabetes.
- 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).
- Participants who can comply with the experimental procedures and related requirements specified in the protocol.
- Volunteers willing to participate in this trial and who have signed the informed consent form.
Exclusion
- Known allergy to disinfectant alcohol or medical-grade skin patches.
- Presence of skin trauma, infection, or skin disease at the site where the trial device is to be worn.
- Hemoglobin levels less than 90.0g/L.
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2.
- Use of other implanted medical devices, such as pacemakers or defibrillators.
- Acutely critically ill patients.
- Patients with active infectious diseases.
- Requirement for imaging examinations, phototherapy, or thermotherapy during the wearing period.
- History of unconscious hypoglycemia in the six months preceding the trial; patients admitted to the hospital at screening are excluded.
- Pregnant women or women planning to become pregnant during the study.
- Inability to read the product instructions or inability to wear the trial device after receiving education and training.
- Participation in another clinical trial within the two weeks prior to screening.
- Other situations determined by the investigator as unsuitable for participation in this trial.
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06197906
Start Date
May 1 2024
End Date
October 1 2024
Last Update
January 9 2024
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