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FreeStyle Libre Pro Use in Primary & Secondary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02434315
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care

Tracking Information
First Submitted Date  ICMJE April 27, 2015
First Posted Date  ICMJE May 5, 2015
Last Update Posted Date September 29, 2016
Study Start Date  ICMJE April 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FreeStyle Libre Pro Use in Primary & Secondary Care
Official Title  ICMJE Evaluation of the FreeStyle Libre Pro for Individuals With Insulin Managed Type 2 Diabetes in Primary & Secondary Care
Brief Summary The purpose of this study is to evaluate the impact of varying amount of FreeStyle Libre Pro wear as measured by time in range.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE
  • Device: FreeStyle Libre Pro 4 sensor wears, 2 with reviews
    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.
  • Device: FreeStyle Libre Pro 6 sensor wears, 4 with reviews
    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.
  • Device: FreeStyle Libre Pro 3 sensor wears
    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.
Study Arms  ICMJE
  • Active Comparator: Group A - Control
    FreeStyle Libre Pro 3 sensor wears
    Intervention: Device: FreeStyle Libre Pro 3 sensor wears
  • Experimental: Group B - Intervention
    FreeStyle Libre Pro 4 sensor wears, 2 with reviews
    Intervention: Device: FreeStyle Libre Pro 4 sensor wears, 2 with reviews
  • Experimental: Group C - Intervention
    FreeStyle Libre Pro 6 sensor wears, 4 with reviews
    Intervention: Device: FreeStyle Libre Pro 6 sensor wears, 4 with reviews
Publications * Ajjan RA, Jackson N, Thomson SA. Reduction in HbA1c using professional flash glucose monitoring in insulin-treated type 2 diabetes patients managed in primary and secondary care settings: A pilot, multicentre, randomised controlled trial. Diab Vasc Dis Res. 2019 Jul;16(4):385-395. doi: 10.1177/1479164119827456.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2016)
175
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2015)
170
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02434315
Other Study ID Numbers  ICMJE ADC-UK-PMS-14024
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Diabetes Care
Study Sponsor  ICMJE Abbott Diabetes Care
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Abbott Diabetes Care
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP