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Long-term, Implantable Sensor Improves Health Outcomes in Patients With T1D

NCT04160156 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-11-12

No results posted yet for this study

Summary

The implantable Eversense ® CGM System obtained CE marking in 2016 for the 90-day device and in 2017 for the 180-day device.There is interest in real-world clinical evidence on the use of Eversense regarding changes in HbA1c and time in range (TIR), time below range (TBR), and time above range (TAR) in patients with type 1 diabetes. This is a prospective, multi-center, observational clinical study among adult participants aged 18 years or older with T1D and Eversense CGM System-naïve aimed to evaluate the change in HbA1c and glucometric parameters (TIR, TAR, TBR, mean daily glucose and standard deviation) in patients with T1D from multiple clinics in Italy using the Eversense CGM System for a 6-month time period.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Long term sensor

Observational study including subjects using long term sensor according to local guidelines and patients preferences

Sponsors & Collaborators

  • University Magna Graecia

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-05
Primary Completion
2019-06-30
Completion
2019-06-30
FDA Device
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04160156 on ClinicalTrials.gov