Skip to main content
OpenTrials
Completed

NCT Number: NCT02434315

FreeStyle Libre Pro Use in Primary & Secondary Care

The purpose of this study is to evaluate the impact of varying amount of FreeStyle Libre Pro wear as measured by time in range.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atherstone Surgery, Atherstone, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age at least 18 years.
  • Type 2 diabetes treated with insulin therapy for at least 6 months prior to study enrolment.
  • HbA1c between 58 and 108 mmol/mol (7.5 and 12.0%) inclusive.

Exclusion criteria

  • Age at least 18 years.
  • Type 2 diabetes treated with insulin therapy for at least 6 months prior to study enrolment.
  • HbA1c between 58 and 108 mmol/mol (7.5 and 12.0%) inclusive.
  • Participant is currently prescribed animal insulin.
  • Total daily dose of insulin (TDD) is >1.75 iu/kg at entry to the study.
  • Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition.
  • Has a pacemaker or any other neurostimulators.
  • Currently prescribed oral, intramuscular or intravenous steroid therapy for any acute or chronic condition or requires it during the study period.
  • Currently receiving dialysis treatment or planning to receive dialysis during the study.
  • Women who are pregnant, plan to become pregnant or become pregnant during the study.
  • Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management.
  • Currently using / has previously used a sensor based Glucose Monitoring System (including retrospective glucose monitoring system) within the last 6 months.
  • Currently using Continuous Subcutaneous Insulin Infusion (CSII).
  • Known (or suspected) allergy to medical grade adhesives.
  • In the investigator's opinion the participant is unsuitable to participate due to any other cause/reason.

Treatment and study plan

FreeStyle Libre Pro 4 sensor wears, 2 with reviews

Device

Subjects will wear the FreeStyle Libre Pro System for 14 days. 2 period of FreeStyle Libre Pro Sensor wear for data review followed by 2 further periods of Sensor wear for time in range measurement with 28 day interval between wears.

FreeStyle Libre Pro 6 sensor wears, 4 with reviews

Device

Subjects will wear the FreeStyle Libre Pro System for 14 days. 4 period of FreeStyle Libre Pro Sensor wear for data review followed by 2 further periods of Sensor wear for time in range measurement with 28 day interval between wears.

FreeStyle Libre Pro 3 sensor wears

Device

Subjects will wear the FreeStyle Libre Pro System for 14 days. 3 periods of Sensor wear for time in range measurement over a period of approximately 8 months.

Primary outcomes

  1. Change from Baseline - time in glucose range - for penultimate sensor wear

    Time frame: 14 day baseline phase compared to day 172 to 187

    Within arm difference in time in range in penultimate period of sensor wear compared to baseline phase

Sponsors and collaborators

Lead sponsor

Abbott Diabetes Care

Industry

Registry information

Official study title

Evaluation of the FreeStyle Libre Pro for Individuals With Insulin Managed Type 2 Diabetes in Primary & Secondary Care

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 5, 2015
Registry last updated
Sep 29, 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.

Published trials that share one or more normalized conditions with this study.