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

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 1
• Interventions: Device: Flash Glucose Monitor

• Registration Number: NCT02677454
• Lead Sponsor: Vastra Gotaland Region

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2015-12
• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-09
• Study Completion: 2016-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Flash Glucose Monitor	Flash Glucose Monitor	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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,(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
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
Pearson Correlation	the whole study period, day 1-14	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
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

Trial Locations

Locations (1)

NU-Hospital Group; 🇸🇪 Uddevalla, Sweden