Trials Sponsors Conditions Drugs Pricing

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

Device: 13 CGM (continuous glucose monitor)

7-12 year old participants

Device: 13 CGM (continuous glucose monitor)

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 participants2-6 year old participants7-12 year old participants

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age2 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodNon-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.

Sponsors & Collaborators

Atlanta Diabetes Associates
Othercollaborator
Sinocare
Industrylead

Study Sites (1)

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

Bruce Bode, MD
Atlanta Diabetes Associates
PRINCIPAL INVESTIGATOR

Enrollment

134 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

13-17 year old participants

7-12 year old participants

2-6 year old participants

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

13-17 year old participants

7-12 year old participants

2-6 year old participants

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations