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

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ClinicalTrials.gov Identifier: NCT02677454
Recruitment Status : Completed
First Posted : February 9, 2016
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus Device: Flash Glucose Monitor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Flash Glucose Monitoring System in Ambulatory Patients With Type 1 Diabetes
Study Start Date : June 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: 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.

Device: Flash Glucose Monitor
Other Name: Abbott Freestyle Libre




Primary Outcome Measures :
  1. Mean Absolute Relative Difference (MARD) [ Time Frame: 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 :
  1. Mean absolute Difference (MAD) [ Time Frame: 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

  2. Pearson Correlation Coefficient [ Time Frame: 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

  3. Mean absolute relative difference (MARD) [ Time Frame: 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

  4. Mean absolute difference MAD [ Time Frame: 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

  5. Pearson Correlation [ Time Frame: 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

  6. Mean absolute relative difference (MARD) [ Time Frame: 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

  7. Mean absolute difference (MAD) [ Time Frame: 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

  8. Pearson Correlation [ Time Frame: 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

  9. questionnaire [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02677454


Locations
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Sweden
NU-Hospital Group
Uddevalla, Sweden
Sponsors and Collaborators
Vastra Gotaland Region
Investigators
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Principal Investigator: Marcus Lind, MD, Phd NU Hospital Group
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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT02677454    
Other Study ID Numbers: Libre
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Vastra Gotaland Region:
Blood Glucose
Blood Glucose Self-Monitoring
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases