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

Vastra Gotaland Region56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 1 Diabetes Mellitus

Interventions

Flash Glucose MonitorDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Type 1 diabetes 2. Adult patients, age 18 or older and \< 75 years 3. Written informed consent - Exclusion Criteria: 1. Pregnancy 2. Patients with severe cognitive dysfunction or other disease which makes FGM use difficult 3. History of allergic reaction to any of the FGMs materials or adhesives in Contact with the skin. 4. History of allergic reaction to chlorhexidine or alcohol anti-septic solution. 5. Continous Glucose Monitor (CGM) or FGM usage in the last month 6. Abnormal skin at the anticipated glucose sensor attachment sites(excessive hair, burn, inflammation, infection, rash, and/or tattoo) \-

Locations (1)

NU-Hospital Group

Uddevalla, Sweden

Outcomes

Primary Outcomes

Mean Absolute Relative Difference (MARD)

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.