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

NCT05806554 | Completed FDA Device

• 1 other identifier: NPI031-CIP-002F
• Study Type: observational
• Target: 159
• Locations: 2 countries
• Sites: 6

Brief Summary

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

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

T1DM

Participants with type 1 diabetes mellitus

Device: Continuous glucose monitoring device

T2DM

Participants with type 2 diabetes mellitus

Device: Continuous glucose monitoring device

Interventions

Continuous glucose monitoring device DEVICE

Continuous glucose monitoring device

T1DM; T2DM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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).

You may not qualify if:

• \. 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.
• \. Participant has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.
• \. 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.
• \. Planned MRI, CT scan or diathermia procedure for the duration of the study.

Sponsors & Collaborators

• Sinocare: lead
• Integrated Medical Development: collaborator

Study Sites (6)

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

PSHI Praxis GmbH

Mainz, 55128, Germany

Location

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Ulm, D-89081, Germany

Location

Related Publications (1)

• Jendrike N, Link M, Oter S, Fei J, Zheng J, Gao F, Gao A, Zhu S, Shi L, Strange P, Flacke F, Eichenlaub M, Freckmann G. Performance of a New Continuous Glucose Monitoring System in German Adults Living with Diabetes. Diabetes Ther. 2025 Dec 29. doi: 10.1007/s13300-025-01832-6. Online ahead of print.

  PMID: 41461989 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Ron Brazg, MD

  RCRC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: July 19, 2023
• Primary Completion: June 13, 2024
• Study Completion: October 22, 2024
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); US (4)