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

Vastra Gotaland Region

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus

Treatments: Device: Flash Glucose Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT02677454

Libre

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Flash Glucose Monitor

Experimental group

Description:

Each patient with Type 1 diabetes will have a subcutaneous tissue FGM sensor inserted. The sensor will produce a maximum of 1440 tissue fluid glucose measurements per 24 hours and 20160 measurements during the 14 day study. The FGM data (Abbott Freestyle Libre) will be compared to the time-matched reference blood glucose measurements. Each ambulatory patient will sample capillary blood with the HemoCue meter and measure the concentration of glucose 6 to 10 times per day for 14 days. The concentration of finger-stick capillary blood glucose will be measured using the self-monitoring blood glucose (SMBG) hemocue meter in their daily living. The subjects will record SMBG, in a written diary. Subjects will dose insulin according to their routine methods throughout the 14 day study.

Treatment:

Device: Flash Glucose Monitor