Accuracy and Precision of the True Vie I3 Continuous Glucose Monitoring System: an Open Label, Multi-Center Trial

The purpose of the investigation is to evaluate the performance of the I3 CGM according to the FDA's special controls for iCGM.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Continuous glucose monitoring device

Detailed Description

Participants will attend a screening visit, 4 clinic visits with Frequent Sampling Testing (FST) at the beginning, 2 in the middle, and end of the I3 CGM sensor wear, and a visit for removal of the I3 CGM. Participants will wear 3 I3 CGM devices for up to 15 days and be instructed to continue their normal daily activities and manage their glucose as usual between in clinic FST per routine care. Participants will not have access to the I3 CGM data for the management of their blood glucose between clinic visits and will continue their usual care including CGM, if they are CGM users.

At the clinic FST visits venous blood samples will be drawn from an intravenous cannula for FST for up to 10 hours for plasma glucose determination. During the clinic visits the investigative site staff will determine the participants' insulin doses and meals and may induce both hypoglycemia and hyperglycemia of up to an hour duration.

• Study Type: Observational
• Enrollment (Actual): 159

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany, 55128
    • PSHI Praxis GmbH
  • Ulm, Germany, D-89081
    • Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
• United States
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Woodland Research Northwest
  • California
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) using an insulin treatment regimen based on carbohydrate (CHO) counting for meal insulin dose determination and 18-80 years of age will be recruited to participate in the study. Both participants using and not using CGM will be recruited, and participants with a wide range of BMIs and ages will be represented.

Description

Inclusion Criteria:

• 1. Patients with T1DM or T2DM diagnosed for at least 6 months. 2. Individual is 18-80 years old, inclusive, at the time of screening. 3. Must be and have been in stable treatment regimen for at least 1 month with a multiple daily insulin dosing regimen (at least two insulin doses with meals daily) or CSII using at least two bolus doses a day with meals, irrespective of delivery device(s).

Exclusion Criteria:

• 1. History of 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 correction factor for high glucose. 5. Hematocrit below 10% under the lower limit of the normal range. 6. Body mass index < 18.5 kg/m2. 7. Inadequate intravenous access on arms. 8. Participant has had a hypoglycemic seizure within the past 6 months prior to enrollment.

  9. Participant has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.

  10. Participant has a history of a seizure disorder. 11. Pregnancy, planned pregnancy within the study period, or unwillingness to use reliable contraception during the study period.

  12. Planned MRI, CT scan or diathermia procedure for the duration of the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
T1DM; Participants with type 1 diabetes mellitus	Device: Continuous glucose monitoring device; Continuous glucose monitoring device
T2DM; Participants with type 2 diabetes mellitus	Device: Continuous glucose monitoring device; Continuous glucose monitoring device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy	percentage of iCGM values in the measuring range less than 70 mg/dL (3.9 mmol/l) within +/- 15 mg/dL (0.83 mmol/l) of the	15 days

Collaborators and Investigators

• Sponsor: Sinocare
• Collaborators: Integrated Medical Development
• Investigators: Principal Investigator: Ron Brazg, MD, RCRC

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2023
• Primary Completion (Actual): June 13, 2024
• Study Completion (Actual): October 22, 2024

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Continuous Glucose Monitoring
• Other Study ID Numbers: NPI031-CIP-002F

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