Clinical trial NCT05348928: A Pilot Study of the Feasibility and Accuracy of the TrueVie CGM System - A Non-Significant Risk Study
Official title: A Pilot Study of the Feasibility and Accuracy of the TrueVie Continuous Glucose Monitoring System - A Non-Significant Risk Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Continuous Glucose Monitoring
Lead sponsor: Sinocare
Sponsor class: INDUSTRY
Collaborators: name: Integrated Medical Development
First posted: 2022-04-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 1 diabetes

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.

Eligibility criteria: Inclusion Criteria:

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 Criteria:

1. Skin adhesive tolerance issues in the area of sensor placement
2. HbA1c \> 9%.
3. Insulin meal dosing based on fixed dose regimens.
4. Absence of established corrective factor for high glucose.
5. Hematocrit below 10% under the lower limit of the normal range.
6. Body mass index \< 20 kg/m2.
7. Inadequate intravenous access on arms.
8. Absence of moderate exercise tolerance per history
9. Pregnancy, planned pregnancy within the study period, or unwillingness to use reliable contraception during the study period.
10. Planned MRI, CT scan or diathermic procedure for the duration of the study.
11. Any medical history of malignant melanoma or breast cancer.
12. 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.
13. History of alcohol or drug abuse within the last year.
14. Any condition that in the opinion of the investigator may interfere successful completion of study procedures.
15. Participation in other clinical trials involving receipt of investigational drug that cannot be disclosed within the last 30 days.
16. Inability or unwillingness to conform to the required protocol procedures including giving informed consent.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 15 days
measure: Incidence of Treatment-Emergent Adverse Device Events
timeFrame: 15 days
measure: Insertion Site Intensity of any Erythema on a Likert scale
timeFrame: 15 days
measure: Insertion Site Erythema Size estimated from Lengths of Major and Minor Axis
timeFrame: 15 days
measure: Edema by Maximal Height from Surrounding Skin Surface
timeFrame: 15 days
Secondary outcomes:
measure: Sensor Accuracy by Mean Absolute Glucose Concentration Difference from Reference
timeFrame: 15 days
Other outcomes:
Locations:
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: Integrated Medical Development
name: Poul Strange, MD, PhD
role: STUDY_DIRECTOR
References: