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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 1, Diabetes Mellitus

Intervention / Treatment
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* Device: Flash Glucose Monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes Adult patients, age 18 or older and < 75 years Written informed consent - Exclusion Criteria: Pregnancy 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) -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flash Glucose Monitor<br>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. | Device: Flash Glucose Monitor<br> <br> * Other names: Abbott Freestyle Libre;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | the whole study period, day 1-14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean absolute Difference (MAD) | Mean absolute difference(MAD) 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 | the whole study period, day 1-14 | 
| Pearson Correlation Coefficient | Pearson correlation coefficient (all values registered during the whole study period)between Freestyle Libre System compared to the capillary reference blood glucose measured with HemoCue | the whole study period, day 1-14 | 
| Mean absolute relative difference (MARD) | The MARD registered during day 1-7 and day 8-14 separately of the Freestyle Libre system compared to the capillary reference blood glucose measured with HemoCue | the whole study period, day 1-14 | 
| Mean absolute difference MAD | The MAD registered during day 1-7 and day 8-14 separately of the Freestyle Libre system compared to the capillary reference blood glucose measured with HemoCue | the whole study period, day 1-14 | 
| Pearson Correlation | The Pearson Correlation (data registered during day 1-7 and day 8-14 separately) between Freestyle Libre system compared to the capillary reference blood glucose measured with HemoCue | the whole study period, day 1-14 | 
| Mean absolute relative difference (MARD) | The MARD,(for data registered inte the following specified glucose ranges: < 4mmol/l, 4-10mmol/l and >10mmol/l) durin the whole study period of the Freestyle Libre system compared to the capillary reference blood glucose measured the HemoCue | the whole study period, day 1-14 | 
| Mean absolute difference (MAD) | The MAD,(for data registered inte the following specified glucose ranges: < 4mmol/l, 4-10mmol/l and >10mmol/l) durin the whole study period of the Freestyle Libre system compared to the capillary reference blood glucose measured the HemoCue | the whole study period, day 1-14 | 
| Pearson Correlation | The Pearson Correlation (for data registered inte the following specified glucose ranges: < 4mmol/l, 4-10mmol/l and >10mmol/l) between Freestyle Libre system compared to the capillary reference blood glucose measured with HemoCue | the whole study period, day 1-14 | 
| questionnaire | The evaluation of the Freestyle Libre system from a questionnaires rated on a VAS-scale (Visual analogue scale), lowest value (0) equaling to Not true at all and highest value (10) equaling to Completely true | the whole study period, day 1-14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Glucose, Blood Glucose Self-Monitoring