FreeStyle Libre Pro Use in Primary & Secondary Care

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434315
• Other study ID #: ADC-UK-PMS-14024
• Status: Completed
• Phase: N/A
• First received: April 27, 2015
• Last updated: September 28, 2016
• Start date: April 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Atherstone Surgery	Atherstone
United Kingdom	Westongrove Partnership	Aylesbury
United Kingdom	Pebsham Surgery	Bexhill
United Kingdom	Omnia Practice	Birmingham
United Kingdom	Hathaway Surgery	Chippenham
United Kingdom	Rowden Surgery	Chippenham
United Kingdom	Pound Hill Medical Group	Crawley
United Kingdom	Claremont Medical Practice	Exmouth
United Kingdom	White Horse Medical Practice	Faringdon
United Kingdom	Parkwood Surgery	Hemel Hempstead
United Kingdom	St James Hospital,	Leeds
United Kingdom	Kings College Hospital	London
United Kingdom	James Cook Hospital	Middlesborough
United Kingdom	Milton Keynes Hospital	Milton Keynes
United Kingdom	Greenwood and Sneinton Centre	Nottingham
United Kingdom	Mortimer Surgery	Reading
United Kingdom	Clifton Medical Centre	Rotherham
United Kingdom	Salford Royal Hospital	Salford
United Kingdom	Ashfields Primary Care Centre	Sandbach
United Kingdom	The Kiltearn Medical Centre	Sandbach
United Kingdom	Albany House Surgery	Wellingborough
United Kingdom	Rothwell Surgery	Wellingborough
United Kingdom	Friarsgate Practice	Winchester

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diabetes Care

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline - time in glucose range - for penultimate sensor wear	Within arm difference in time in range in penultimate period of sensor wear compared to baseline phase	14 day baseline phase compared to day 172 to 187	No