CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 350 enrolled
Drug / intervention
Flash Glucose Monitoring-FGMdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04060732
NCT04060732N/ACompleted

Feasibility and Safety of "Flash Glucose Monitoring-FGM" in an Adult and Selected Pediatric Population.

Azienda Ospedaliero-Universitaria di Parma·observational·Posted Aug 19, 2019·Updated Jan 13, 2021

In Brief

An observational study evaluating Flash Glucose Monitoring-FGM for Diabetes Mellitus, Type 1. Completed, enrolled 350 participants across 1 site.

Detailed Summary

Diabetes is reaching epidemic proportions and a targeted glucose control is key to prevent microvascular complications as well as long-term macrovascular disease. Self-monitoring of blood glucose (SMBG) in type 1 diabetes (T1D) is mandatory to implement safe and effective adjustments in insulin therapy in order to reduce glucose levels and prevent hypoglycemic episodes. It is known that a higher rate of glucose testing (up to 8 times/day) is associated with improved glucose control, however, long-term repeated daily glucose tests are painful, inconvenient and difficult to pursue. Continuous glucose monitoring (CGM) is an alternative to SMBG, but the use of conventional CGM has been limited by the need of repeated calibration using capillary glucose testing, relatively short sensor lifespan and high costs. The recently introduced CGM FreeStyle Libre™ (Abbott Diabetes Care, Witney, UK) flash glucose monitoring (FGM), a new generation of glucose testing device, has the advantage to be user friendly by just scanning the reader over the sensor. The FGM system does not require calibration, has a long sensor lifetime of 14 days and it's relatively affordable, explaining the widespread use of the device. The Flash Glucose Monitoring-FGM is a real-time glycemic monitoring system called "hybrid" as it is not equipped with alarms capable of alerting the patient to cut-off value for the hypo- or hyperglycemia, but allows the glycemic trend to be viewed at request.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 19, 2019
Enrollment StartMay 5, 2017
Primary CompletionJan 31, 2020
Study CompletionDec 30, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 6.9 years ago

Interventions

Flash Glucose Monitoring-FGMdevice

The Flash Glucose Monitoring-FGM is a real-time glycemic monitoring system called "hybrid" will be assigned to the enrolled patients at baseline until the end of follow-up after 12 months.