NCT05908448

The True Vie I3 Continuous Glucose Monitoring System in Pediatric Patients With Type 1 Diabetes Mellitus

Accuracy and Precision of the True Vie I3 Continuous Glucose Monitoring System in Pediatric Patients With Type 1 Diabetes Mellitus: an Open Label, Multi-Center Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 134 (actual)
• Sponsor: Sinocare · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the investigation is to evaluate the performance of the I3 CGM in Pediatric Patients with Type 1 Diabetes Mellitus (T1DM) according to the FDA's special controls for iCGM.

Detailed description

All participants have T1DM and will continue normal daily activities and manage their glucose as usual between clinic visits. Participants will not have access to the I3 CGM data for the management of their BG between clinic visits and will continue their usual care including CGM, if they are CGM users. 2-6 year old participants: Participants will have 2 sensors inserted in the upper buttocks by their guardian. Participants will complete one frequent sampling clinic visit of 4 hour duration with the goal of 10-15 BG measurements analyzed using a BG meter. For the 2-6 year olds, there are no specific fasting or other dietary requirements during the visits, participants will be provided meal choices as needed when they are hungry and meals will be served as it fits the clinic's schedule. Study staff will determine meal and insulin doses. No attempts at manipulating glucose will be made in this age group. 7-17 year old participants will attend a screening visit, an I3 CGM insertion visit, 2 clinic visits with frequent sample testing (FST) of 6 hour duration early and late in the 15 day I3 CGM sensor life. At the 2 FST clinic visits venous blood samples will be drawn for FST over 6 hours for plasma glucose determination using a Yellow Springs Instrument 2300 Stat Plus Glucose and Lactate Analyzer (YSI). Participants will wear 3 sensors in two anatomical locations for 15 days and complete a 6 hour frequent sampling day at the beginning and the end of the sensor life. For the 7-12 year olds, there are no specific fasting or other dietary requirements during the visits, participants will be provided meal choices as needed when they are hungry and meals will be served as it fits the clinic's schedule. Study staff will determine meal and insulin doses. No attempts at manipulating glucose will be made in this age group. For the 13-17 year old participants, the investigative site staff will determine the participants' insulin doses and food intake and thus manipulate blood glucose to study the device over its full operating range. There will only be one glucose manipulation session during a FST visit.

Conditions

• T1DM - Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	13 CGM (continuous glucose monitor)	The I3 CGM consists of three main components: a Sensor Pack (Applicator-Sensor assembly), a Transmitter Pack (with Bluetooth Low Energy (BLE)) and a mobile application (I3 CGM App). The user can view their glucose data on the I3 CGM App running on a compatible mobile device.

Timeline

• Start date: 2024-02-07
• Primary completion: 2024-10-18
• Completion: 2024-11-13
• First posted: 2023-06-18
• Last updated: 2024-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study