A Pilot Study of the Feasibility and Accuracy of the TrueVie Continuous Glucose Monitoring System - A Non-Significant Risk Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Continuous Glucose Monitoring
- Sponsor
- Sinocare Meditech Inc.
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Device Events
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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 modifications.
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 to 3 clinic visits at the beginning, middle and end of the 15 days intended sensor life. At the clinic visits participants are served two meals and perform a brief period of exercise of moderate intensity while blood samples are drawn according to a planned schedule timed to coincide with the TrueVie measurements.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Type 1 diabetes mellitus
- •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).
- •Must have normal exercise tolerance.
Exclusion Criteria
- •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/m
- •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.
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Device Events
Time Frame: 15 days
safety is assessed by adverse device effects
Incidence of Treatment-Emergent Adverse Events
Time Frame: 15 days
safety is assessed by adverse events
Insertion Site Erythema Size estimated from Lengths of Major and Minor Axis
Time Frame: 15 days
tolerability by size of erythema at the insertion site
Insertion Site Intensity of any Erythema on a Likert scale
Time Frame: 15 days
tolerability by intensity of erythema at the insertion site
Edema by Maximal Height from Surrounding Skin Surface
Time Frame: 15 days
tolerability by edema at insertion site
Secondary Outcomes
- Sensor Accuracy by Mean Absolute Glucose Concentration Difference from Reference(15 days)