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

November 14, 2016 updated by: Vastra Gotaland Region
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uddevalla, Sweden
        • NU-Hospital Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Abbott Freestyle Libre

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Investigators

  • Principal Investigator: Marcus Lind, MD, Phd, NU-Hospital Organization, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

January 7, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (ESTIMATE)

February 9, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 14, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Libre

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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