Status:
COMPLETED
A Pilot Study of the Feasibility and Accuracy of the TrueVie CGM System - A Non-Significant Risk Study
Lead Sponsor:
Sinocare Meditech Inc.
Collaborating Sponsors:
Integrated Medical Development
Conditions:
Continuous Glucose Monitoring
Eligibility:
All Genders
18-65 years
Brief Summary
The purpose of the investigation is to obtain sufficient preliminary information about the performance of the TrueVie Continuous Glucose Monitoring (CGM) device to identify any need for any design mod...
Detailed Description
After being informed about the study and potential risks, all participants giving written informed consent will be screened for participation. Qualifying participants will insert CGM sensors and come ...
Eligibility Criteria
Inclusion
- 1 Type 1 diabetes mellitus 2. Must be and have been in stable treatment regimen for at least 3 months with a multiple daily insulin dosing regimens or Continuous Subcutaneous Insulin Infusion (CSII), irrespective of delivery device(s).
- 3\. Must have normal exercise tolerance.
Exclusion
- Skin adhesive tolerance issues in the area of sensor placement
- HbA1c \> 9%.
- Insulin meal dosing based on fixed dose regimens.
- Absence of established corrective factor for high glucose.
- Hematocrit below 10% under the lower limit of the normal range.
- Body mass index \< 20 kg/m2.
- Inadequate intravenous access on arms.
- Absence of moderate exercise tolerance per history
- Pregnancy, planned pregnancy within the study period, or unwillingness to use reliable contraception during the study period.
- Planned MRI, CT scan or diathermic procedure for the duration of the study.
- Any medical history of malignant melanoma or breast cancer.
- Medical history of any other cancers within the last five years except adequately treated basal cell or squamous carcinoma of the skin, or cervical carcinoma in-situ.
- History of alcohol or drug abuse within the last year.
- Any condition that in the opinion of the investigator may interfere successful completion of study procedures.
- Participation in other clinical trials involving receipt of investigational drug that cannot be disclosed within the last 30 days.
- Inability or unwillingness to conform to the required protocol procedures including giving informed consent.
Key Trial Info
Start Date :
May 4 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 16 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05348928
Start Date
May 4 2022
End Date
June 16 2022
Last Update
June 30 2022
Active Locations (1)
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1
Rainier Clinical Research Center
Renton, Washington, United States, 98057