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Trial record 2 of 115 for:    libre 3

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

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: FreeStyle Libre Pro 4 sensor wears, 2 with reviews Device: FreeStyle Libre Pro 6 sensor wears, 4 with reviews Device: FreeStyle Libre Pro 3 sensor wears Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Evaluation of the FreeStyle Libre Pro for Individuals With Insulin Managed Type 2 Diabetes in Primary & Secondary Care
Study Start Date : April 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A - Control
FreeStyle Libre Pro 3 sensor 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.

Experimental: Group B - Intervention
FreeStyle Libre Pro 4 sensor wears, 2 with reviews
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.

Experimental: Group C - Intervention
FreeStyle Libre Pro 6 sensor wears, 4 with reviews
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.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434315


Locations
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Sponsors and Collaborators
Abbott Diabetes Care
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT02434315    
Other Study ID Numbers: ADC-UK-PMS-14024
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Keywords provided by Abbott Diabetes Care:
Diabetes Mellitus
Sensing Technology
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases