Evaluation of a Flash Glucose Monitoring System in Ambulatory Patients With Type 1 Diabetes

Vastra Gotaland Region1 site in 1 country56 target enrollmentJune 2015

ConditionsDiabetes Mellitus, Type 1 Diabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 1
Sponsor: Vastra Gotaland Region
Enrollment: 56
Locations: 1
Primary Endpoint: Mean Absolute Relative Difference (MARD)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the accuracy of the Flash Glucose Monitoring system (FGM), Abbot FreeStyle Libre, used today in clinical practice in Sweden in estimating plasma glucose levels. Data will be collected in ambulatory patients with type 1 diabetes to determine safety, accuracy, and reliability.

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

April 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Vastra Gotaland Region

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Type 1 diabetes
•Adult patients, age 18 or older and \< 75 years
•Written informed consent -

Exclusion Criteria

•Patients with severe cognitive dysfunction or other disease which makes FGM use difficult
•History of allergic reaction to any of the FGMs materials or adhesives in Contact with the skin.
•History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
•Continous Glucose Monitor (CGM) or FGM usage in the last month
•Abnormal skin at the anticipated glucose sensor attachment sites(excessive hair, burn, inflammation, infection, rash, and/or tattoo)

Outcomes

Primary Outcomes

Mean Absolute Relative Difference (MARD)

Time Frame: the whole study period, day 1-14

Mean absolute relative difference (MARD) of all estimated capillary glucose values registered during the whole study period of the Freestyle Libre system compared to the capillary reference blood glucose measured with HemoCue.