Diabetes Mellitus, Diabetes Mellitus, Type 1
Conditions
Keywords
Blood Glucose, Blood Glucose Self-Monitoring
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.
Interventions
DEVICEFlash Glucose Monitor
Sponsors
Vastra Gotaland Region
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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) \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Absolute Relative Difference (MARD) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pearson Correlation Coefficient | the whole study period, day 1-14 | 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 |
| Mean absolute relative difference (MARD) | the whole study period, day 1-14 | 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 |
| Mean absolute difference MAD | the whole study period, day 1-14 | 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 |
| Mean absolute Difference (MAD) | the whole study period, day 1-14 | 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 |
| Mean absolute difference (MAD) | the whole study period, day 1-14 | 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 |
| questionnaire | the whole study period, day 1-14 | 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 |
| Pearson Correlation | the whole study period, day 1-14 | 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 |
Countries
Sweden
Outcome results
None listed