Clinical trial NCT02434315: FreeStyle Libre Pro Use in Primary & Secondary Care
Official title: Evaluation of the FreeStyle Libre Pro for Individuals With Insulin Managed Type 2 Diabetes in Primary & Secondary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Sensing Technology
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2015-05-05
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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.

Primary outcomes:
measure: Change from Baseline - time in glucose range - for penultimate sensor wear
timeFrame: 14 day baseline phase compared to day 172 to 187
Secondary outcomes:
Other outcomes:
Locations:
city: Atherstone
country: United Kingdom
facility: Atherstone Surgery
city: Aylesbury
country: United Kingdom
facility: Westongrove Partnership
city: Bexhill
country: United Kingdom
facility: Pebsham Surgery
city: Birmingham
country: United Kingdom
facility: Omnia Practice
city: Chippenham
country: United Kingdom
facility: Hathaway Surgery
city: Chippenham
country: United Kingdom
facility: Rowden Surgery
city: Crawley
country: United Kingdom
facility: Pound Hill Medical Group
city: Exmouth
country: United Kingdom
facility: Claremont Medical Practice
city: Faringdon
country: United Kingdom
facility: White Horse Medical Practice
city: Hemel Hempstead
country: United Kingdom
facility: Parkwood Surgery
city: Leeds
country: United Kingdom
facility: St James Hospital,
city: London
country: United Kingdom
facility: Kings College Hospital
city: Middlesborough
country: United Kingdom
facility: James Cook Hospital
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes Hospital
city: Nottingham
country: United Kingdom
facility: Greenwood and Sneinton Centre
city: Reading
country: United Kingdom
facility: Mortimer Surgery
city: Rotherham
country: United Kingdom
facility: Clifton Medical Centre
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
city: Sandbach
country: United Kingdom
facility: Ashfields Primary Care Centre
city: Sandbach
country: United Kingdom
facility: The Kiltearn Medical Centre
city: Wellingborough
country: United Kingdom
facility: Albany House Surgery
city: Wellingborough
country: United Kingdom
facility: Rothwell Surgery
city: Winchester
country: United Kingdom
facility: Friarsgate Practice
Study officials:
References:
citation: 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.