FreeStyle Libre Pro Use in Primary & Secondary Care
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline - time in glucose range - for penultimate sensor wear [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
Eligibility Criteria
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:
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Age at least 18 years.
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Type 2 diabetes treated with insulin therapy for at least 6 months prior to study enrolment.
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HbA1c between 58 and 108 mmol/mol (7.5 and 12.0%) inclusive.
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Participant is currently prescribed animal insulin.
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Total daily dose of insulin (TDD) is >1.75 iu/kg at entry to the study.
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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.
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Has a pacemaker or any other neurostimulators.
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Currently prescribed oral, intramuscular or intravenous steroid therapy for any acute or chronic condition or requires it during the study period.
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Currently receiving dialysis treatment or planning to receive dialysis during the study.
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Women who are pregnant, plan to become pregnant or become pregnant during the study.
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Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management.
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Currently using / has previously used a sensor based Glucose Monitoring System (including retrospective glucose monitoring system) within the last 6 months.
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Currently using Continuous Subcutaneous Insulin Infusion (CSII).
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Known (or suspected) allergy to medical grade adhesives.
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In the investigator's opinion the participant is unsuitable to participate due to any other cause/reason.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Atherstone Surgery | Atherstone | United Kingdom | ||
| 2 | Westongrove Partnership | Aylesbury | United Kingdom | ||
| 3 | Pebsham Surgery | Bexhill | United Kingdom | ||
| 4 | Omnia Practice | Birmingham | United Kingdom | ||
| 5 | Hathaway Surgery | Chippenham | United Kingdom | ||
| 6 | Rowden Surgery | Chippenham | United Kingdom | ||
| 7 | Pound Hill Medical Group | Crawley | United Kingdom | ||
| 8 | Claremont Medical Practice | Exmouth | United Kingdom | ||
| 9 | White Horse Medical Practice | Faringdon | United Kingdom | ||
| 10 | Parkwood Surgery | Hemel Hempstead | United Kingdom | ||
| 11 | St James Hospital, | Leeds | United Kingdom | LS9 7TF | |
| 12 | Kings College Hospital | London | United Kingdom | ||
| 13 | James Cook Hospital | Middlesborough | United Kingdom | ||
| 14 | Milton Keynes Hospital | Milton Keynes | United Kingdom | ||
| 15 | Greenwood and Sneinton Centre | Nottingham | United Kingdom | ||
| 16 | Mortimer Surgery | Reading | United Kingdom | ||
| 17 | Clifton Medical Centre | Rotherham | United Kingdom | ||
| 18 | Salford Royal Hospital | Salford | United Kingdom | ||
| 19 | Ashfields Primary Care Centre | Sandbach | United Kingdom | ||
| 20 | The Kiltearn Medical Centre | Sandbach | United Kingdom | ||
| 21 | Albany House Surgery | Wellingborough | United Kingdom | ||
| 22 | Rothwell Surgery | Wellingborough | United Kingdom | ||
| 23 | Friarsgate Practice | Winchester | United Kingdom |
Sponsors and Collaborators
- Abbott Diabetes Care
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ADC-UK-PMS-14024