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NCT02677454 Clinical Trial

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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02677454
Other study ID # Libre
Secondary ID
Status Completed
Phase N/A
First received January 7, 2016
Last updated November 14, 2016
Start date June 2015
Est. completion date April 2016

Study information
Verified date November 2016
Source Vastra Gotaland Region
Contact n/a
Is FDA regulated No
Health authority Sweden: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date April 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 74 Years
Eligibility 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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Flash Glucose Monitor

Locations
Country Name City State
Sweden NU-Hospital Group Uddevalla

Sponsors (1)
Lead Sponsor Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
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