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FreeStyle Libre Pro Use in Primary & Secondary Care

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Abbott

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Device: FreeStyle Libre Pro 3 sensor wears
Device: FreeStyle Libre Pro 6 sensor wears, 4 with reviews
Device: FreeStyle Libre Pro 4 sensor wears, 2 with reviews

Study type

Interventional

Funder types

Industry

Identifiers

NCT02434315
ADC-UK-PMS-14024

Details and patient eligibility

About

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

Enrollment

175 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

175 participants in 3 patient groups

Group A - Control
Active Comparator group
Description:
FreeStyle Libre Pro 3 sensor wears
Treatment:
Device: FreeStyle Libre Pro 3 sensor wears
Group B - Intervention
Experimental group
Description:
FreeStyle Libre Pro 4 sensor wears, 2 with reviews
Treatment:
Device: FreeStyle Libre Pro 4 sensor wears, 2 with reviews
Group C - Intervention
Experimental group
Description:
FreeStyle Libre Pro 6 sensor wears, 4 with reviews
Treatment:
Device: FreeStyle Libre Pro 6 sensor wears, 4 with reviews

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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