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

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

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.

Study Overview

• Status: Completed
• Conditions: Continuous Glucose Monitoring
• Intervention / Treatment: Device: Continuous glucose monitoring device; Other: Laboratory plasma glucose concentration determination

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 Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with type 1 diabetes

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
With oral ascorbic acid; 1 g ascorbic acid orally	Device: Continuous glucose monitoring device; Continuous glucose monitoring device; Other: Laboratory plasma glucose concentration determination; Laboratory plasma glucose concentration determination
Without oral ascorbic acid; No oral ascorbic acid is taken	Device: Continuous glucose monitoring device; Continuous glucose monitoring device; Other: Laboratory plasma glucose concentration determination; Laboratory plasma glucose concentration determination

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sinocare Meditech Inc.
• Collaborators: Integrated Medical Development
• Investigators: Study Director: Poul Strange, MD, PhD, Integrated Medical Development

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 4, 2022
• Primary Completion (ACTUAL): June 16, 2022
• Study Completion (ACTUAL): June 16, 2022

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (ACTUAL): April 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: NPI031-CEP-001F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No