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

Completed

• Conditions: Continuous Glucose Monitoring
• Interventions: Device: Continuous glucose monitoring device; Other: Laboratory plasma glucose concentration determination

• Registration Number: NCT05348928
• Lead Sponsor: Sinocare Meditech Inc.

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.

Study Timeline

• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-04-27
• Status Verified: 2022-05
• Study Start: 2022-05-04
• Primary Completion: 2022-06-16
• Study Completion: 2022-06-16
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
With oral ascorbic acid	Laboratory plasma glucose concentration determination	1 g ascorbic acid orally
Without oral ascorbic acid	Continuous glucose monitoring device	No oral ascorbic acid is taken
With oral ascorbic acid	Continuous glucose monitoring device	1 g ascorbic acid orally
Without oral ascorbic acid	Laboratory plasma glucose concentration determination	No oral ascorbic acid is taken

Primary Outcome Measures

Name	Time	Method
Insertion Site Intensity of any Erythema on a Likert scale	15 days	tolerability by intensity of erythema at the insertion site
Incidence of Treatment-Emergent Adverse Device Events	15 days	safety is assessed by adverse device effects
Incidence of Treatment-Emergent Adverse Events	15 days	safety is assessed by adverse events
Insertion Site Erythema Size estimated from Lengths of Major and Minor Axis	15 days	tolerability by size of erythema at the insertion site
Edema by Maximal Height from Surrounding Skin Surface	15 days	tolerability by edema at insertion site

Secondary Outcome Measures

Name	Time	Method
Sensor Accuracy by Mean Absolute Glucose Concentration Difference from Reference	15 days	Sensor accuracy will be determined against plasma glucose concentrations determined by laboratory quality instrumentation

Trial Locations

Locations (1)

Rainier Clinical Research Center; 🇺🇸 Renton, Washington, United States