A Pilot Study of the Feasibility and Accuracy of the TrueVie CGM System - A Non-Significant Risk Study

Continuous Glucose Monitoring Clinical Trial

Official title:

A Pilot Study of the Feasibility and Accuracy of the TrueVie Continuous Glucose Monitoring System - A Non-Significant Risk Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05348928
• Other study ID #: NPI031-CEP-001F
• Status: Completed
• Start date: May 4, 2022
• Est. completion date: June 16, 2022

Study information

• Verified date: May 2022
• Source: Sinocare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 16, 2022
• Est. primary completion date: June 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Continuous Glucose Monitoring

Intervention

Device:
• Continuous glucose monitoring device
Continuous glucose monitoring device

Other:
• Laboratory plasma glucose concentration determination
Laboratory plasma glucose concentration determination

Locations

Country	Name	City	State
United States	Rainier Clinical Research Center	Renton	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Sinocare Meditech Inc.	Integrated Medical Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	safety is assessed by adverse events	15 days
Primary	Incidence of Treatment-Emergent Adverse Device Events	safety is assessed by adverse device effects	15 days
Primary	Insertion Site Intensity of any Erythema on a Likert scale	tolerability by intensity of erythema at the insertion site	15 days
Primary	Insertion Site Erythema Size estimated from Lengths of Major and Minor Axis	tolerability by size of erythema at the insertion site	15 days
Primary	Edema by Maximal Height from Surrounding Skin Surface	tolerability by edema at insertion site	15 days
Secondary	Sensor Accuracy by Mean Absolute Glucose Concentration Difference from Reference	Sensor accuracy will be determined against plasma glucose concentrations determined by laboratory quality instrumentation	15 days