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NCT Number: NCT02677454

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NU-Hospital Group

Uddevalla, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

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Treatment and study plan

Flash Glucose Monitor

Device

Other names: Abbott Freestyle Libre

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Feb 9, 2016
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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