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

NCT05908448 | Completed DMC FDA Device

• 1 other identifier: NPI031-CIP-003F
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

T1DM - Type 1 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 YSI control

  0-15 days

Study Arms (3)

13-17 year old participants

13-17 year old participants

Device: 13 CGM (continuous glucose monitor)

7-12 year old participants

7-12 year old participants

Device: 13 CGM (continuous glucose monitor)

2-6 year old participants

2-6 year old participants

Device: 13 CGM (continuous glucose monitor)

Interventions

13 CGM (continuous glucose monitor) DEVICE

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.

13-17 year old participants; 2-6 year old participants; 7-12 year old participants

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

2-17 year old patients with type 1 diabetes mellitus.

You may qualify if:

• Patients with T1DM diagnosed for at least 6 months aged 2-17 years old, inclusive.
• Must be and have been in stable treatment regimen for at least 1 month with a multiple daily insulin dosing regimen or CSII, irrespective of delivery device(s). For this criterion, "stable treatment regimen" is considered no changes in prescribed number of insulin deliveries a day, and a change in total daily insulin dose of less than 10%.

You may not qualify if:

• History of skin adhesive tolerance issues in the area of sensor placement.
• Insulin meal dosing based on fixed dose regimens.
• For 13-17 years old only: Absence of established correction factor for high glucose.
• Hematocrit below 10% under the lower limit of the normal range by less than 3 month old laboratory test in history, a centrifuge or POC meter test.
• For 7-17 year old: inadequate intravenous access on arms.
• Participant has had a severe hypoglycemic event requiring 3rd party assistance within the past 6 months prior to enrollment.
• Conditions which may predispose subjects to hypoglycemia including, but not limited to, thyroid disease which is not well controlled, adrenal insufficiency, high dose steroid use in recent past or planned during study, significant renal or liver disease.
• 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.
• For girls of reproductive potential: 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.
• Any medical history of malignant melanoma or breast cancer.
• 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.
• Medical history of stroke, transitory cerebral ischemia, myocardial infarction, unstable angina or heart failure with in the past 12 months.
• History of alcohol or drug abuse within the last year.

Sponsors & Collaborators

• Sinocare: lead
• Atlanta Diabetes Associates: collaborator

Study Sites (1)

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bruce Bode, MD

  Atlanta Diabetes Associates

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 18, 2023
• Study Start: February 7, 2024
• Primary Completion: October 18, 2024
• Study Completion: November 13, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-02

Locations

US (1)