NCT02677454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

January 7, 2016

Last Update Submit

November 14, 2016

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Keywords

Blood GlucoseBlood Glucose Self-Monitoring

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Mean absolute Difference (MAD)

    the whole study period, day 1-14

  • Pearson Correlation Coefficient

    the whole study period, day 1-14

  • Mean absolute relative difference (MARD)

    the whole study period, day 1-14

  • Mean absolute difference MAD

    the whole study period, day 1-14

  • Pearson Correlation

    the whole study period, day 1-14

  • +4 more secondary outcomes

Study Arms (1)

Flash Glucose Monitor

EXPERIMENTAL

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

Interventions

Flash Glucose MonitorDEVICE
Also known as: Abbott Freestyle Libre
Flash Glucose Monitor

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes
  • Adult patients, age 18 or older and \< 75 years
  • Written informed consent -

You may not qualify if:

  • Pregnancy
  • Patients with severe cognitive dysfunction or other disease which makes FGM use difficult
  • History of allergic reaction to any of the FGMs materials or adhesives in Contact with the skin.
  • History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
  • Continous Glucose Monitor (CGM) or FGM usage in the last month
  • Abnormal skin at the anticipated glucose sensor attachment sites(excessive hair, burn, inflammation, infection, rash, and/or tattoo)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NU-Hospital Group

Uddevalla, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Marcus Lind, MD, Phd

    NU-Hospital Organization, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2016

First Posted

February 9, 2016

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

April 1, 2016

Last Updated

November 15, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)