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

Last updated: December 2, 2024
Sponsor: Sinocare
Overall Status: Completed

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

Continuous glucose monitoring device

Clinical Study ID

NCT05806554
NPI031-CIP-002F
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 beenin stable treatment regimen for at least 1 month with a multiple daily insulindosing regimen (at least two insulin doses with meals daily) or CSII using atleast two bolus doses a day with meals, irrespective of delivery device(s).

Exclusion

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 ofestablished correction factor for high glucose. 5. Hematocrit below 10% underthe 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 hypoglycemicseizure within the past 6 months prior to enrollment.

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

  3. Participant has a history of a seizure disorder. 11. Pregnancy, plannedpregnancy within the study period, or unwillingness to use reliablecontraception during the study period.

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

Study Design

Total Participants: 159
Treatment Group(s): 1
Primary Treatment: Continuous glucose monitoring device
Phase:
Study Start date:
July 19, 2023
Estimated Completion Date:
October 22, 2024

Study 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.

Connect with a study center

  • Diablo Clinical Research

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Atlanta Diabetes Associates

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Rainier Clinical Research Center

    Renton, Washington 98057
    United States

    Site Not Available

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