--- title: FreeStyle Libre Pro Use in Primary & Secondary Care nct_id: NCT02434315 overall_status: COMPLETED phase: NA sponsor: Abbott Diabetes Care study_type: INTERVENTIONAL primary_condition: Diabetes Mellitus countries: United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02434315.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02434315" ct_last_update_post_date: 2016-09-29 last_seen_at: "2026-05-12T06:47:10.485Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **NCT ID:** [NCT02434315](https://clinicaltrials.gov/study/NCT02434315) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 175 - **Lead Sponsor:** Abbott Diabetes Care - **Conditions:** Diabetes Mellitus - **Start Date:** 2015-04 - **Completion Date:** 2016-09 - **CT.gov Last Update:** 2016-09-29 ## 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 - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. ``` ## Arms - **Group A - Control** (ACTIVE_COMPARATOR) — FreeStyle Libre Pro 3 sensor wears - **Group B - Intervention** (EXPERIMENTAL) — FreeStyle Libre Pro 4 sensor wears, 2 with reviews - **Group C - Intervention** (EXPERIMENTAL) — FreeStyle Libre Pro 6 sensor wears, 4 with reviews ## Interventions - **FreeStyle Libre Pro 4 sensor wears, 2 with reviews** (DEVICE) — 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** (DEVICE) — 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** (DEVICE) — 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. ## Primary Outcomes - **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 ## Locations (23) - Atherstone Surgery, Atherstone, United Kingdom - Westongrove Partnership, Aylesbury, United Kingdom - Pebsham Surgery, Bexhill-on-Sea, 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, Middlesbrough, 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, United Kingdom ## Recent Field Changes (last 30 days) - `eligibility.sex` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.atherstone surgery|atherstone||united kingdom` — added _(2026-05-12)_ - `locations.westongrove partnership|aylesbury||united kingdom` — added _(2026-05-12)_ - `locations.pebsham surgery|bexhill-on-sea||united kingdom` — added _(2026-05-12)_ - `locations.omnia practice|birmingham||united kingdom` — added _(2026-05-12)_ - `locations.hathaway surgery|chippenham||united kingdom` — added _(2026-05-12)_ - `locations.rowden surgery|chippenham||united kingdom` — added _(2026-05-12)_ - `locations.pound hill medical group|crawley||united kingdom` — added _(2026-05-12)_ - `locations.claremont medical practice|exmouth||united kingdom` — added _(2026-05-12)_ - `locations.white horse medical practice|faringdon||united kingdom` — added _(2026-05-12)_ - `locations.parkwood surgery|hemel hempstead||united kingdom` — added _(2026-05-12)_ - `locations.st james hospital,|leeds||united kingdom` — added _(2026-05-12)_ - `locations.kings college hospital|london||united kingdom` — added _(2026-05-12)_ - `locations.james cook hospital|middlesbrough||united kingdom` — added _(2026-05-12)_ - `locations.milton keynes hospital|milton keynes||united kingdom` — added _(2026-05-12)_ - `locations.greenwood and sneinton centre|nottingham||united kingdom` — added _(2026-05-12)_ - `locations.mortimer surgery|reading||united kingdom` — added _(2026-05-12)_ - `locations.clifton medical centre|rotherham||united kingdom` — added _(2026-05-12)_ - `locations.salford royal hospital|salford||united kingdom` — added _(2026-05-12)_ - `locations.ashfields primary care centre|sandbach||united kingdom` — added _(2026-05-12)_ - `locations.the kiltearn medical centre|sandbach||united kingdom` — added _(2026-05-12)_ - `locations.albany house surgery|wellingborough||united kingdom` — added _(2026-05-12)_ - `locations.rothwell surgery|wellingborough||united kingdom` — added _(2026-05-12)_ - `locations.friarsgate practice|winchester||united kingdom` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02434315.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02434315* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*