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Diabetes Mellitus, Type 1NCT02677454

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

A study testing Flash Glucose Monitor in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, run by Vastra Gotaland Region at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Diabetes Mellitus, Type 1, Diabetes Mellitus
What is being tested?
Flash Glucose Monitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteSweden
Study dates
Jun 2015to Apr 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)
  • -

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • NU-Hospital Group

    Uddevalla

Other trials in Sweden

About this study

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.

Being tested
Flash Glucose Monitor
Keywords
Blood Glucose, Blood Glucose Self-Monitoring
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flash Glucose MonitorDevice

    Also called Abbott Freestyle Libre

Study groups in NCT02677454
Study groupRoleWhat they receive
Flash Glucose MonitorExperimentalEach 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.
Receives: Device: Flash Glucose Monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: the whole study period, day 1-14

Secondary outcomes (9)

  1. 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

    Measured: the whole study period, day 1-14

  2. 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

    Measured: the whole study period, day 1-14

  3. 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

    Measured: the whole study period, day 1-14

  4. 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

    Measured: the whole study period, day 1-14

  5. 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

    Measured: the whole study period, day 1-14

  6. 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

    Measured: the whole study period, day 1-14

  7. 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

    Measured: the whole study period, day 1-14

  8. 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

    Measured: the whole study period, day 1-14

  9. 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

    Measured: the whole study period, day 1-14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2016 (estimated)
  2. Study startJun 2015
  3. Primary completionDec 2015
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02677454
Sponsor's protocol ID
Libre
Status last verified
Nov 2016
First submitted
7 Jan 2016
Last updated
15 Nov 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Flash Glucose Monitor in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, run by Vastra Gotaland Region at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Absolute Relative Difference (MARD) (time frame: the whole study period, day 1-14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02677454.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.

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