Freestyle Libre and Hospital Admissions in Type 2 Diabetes
NCT ID: NCT04997512
Last Updated: 2021-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2021-11-01
2025-08-01
Brief Summary
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Detailed Description
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In this trial, the investigators will randomise individuals with type 2 diabetes who have suffered an episode of severe hypoglycaemia requiring emergency service call out to two arms. One arm will receive standard of care/treatment as usual and the other will receive a structured nurse led intervention as well as the use of a flash glucose monitoring system, Freestyle libre.
Active participation in the trial for both arms will be a total of twelve months (with the main intervention months 0-6.) Participants electronic records will be analysed for death and unscheduled healthcare contacts for a total of two years after recruitment.
The primary outcome measure is mortality between groups. Secondary outcomes include the use of estimated HbA1c (a variable produced by the freestyle libre device) compared to laboratory HbA1c, quality of life measures, effects on glycemic control and the number of unscheduled healthcare contacts.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of care
Participants are returned to the care of their usual diabetes care provider following randomisation. They will donate blood and urine samples as well as completing diabetes specific questionnaires at 0 and 6 months. They will also wear a blinded glucose sensor (freestyle Libre PRO) for a two week period at month 6.
No interventions assigned to this group
Intervention arm
Participants will be randomised at baseline. They will provide blood and urine samples at months 0 and 6 as well as fill in diabetes specific questionnaires. They will receive education surrounding hypoglycaemia at baseline from a diabetes specialist nurse. They will wear a freestyle libre device which is changed every two weeks for a period of 6 months. At weeks 2,4,12 and 24 they will have their diabetes medication adjusted by the diabetes specialist nurse/diabetes doctor according to their blood glucose profiles, analysed from the data generated by freestyle libre.
Freestyle libre
A glucose sensor (flash) which measures interstitial blood glucose every 15 minutes or on demand.
Nurse led structured intervention - hypoglycaemia education and diabetes treatment modification modification
An education programme surrounding avoidance of hypoglycaemia at baseline. Regular review (weeks 2, 4, 12 and 24) and adjustment of diabetes medications based on freestyle libre data.
Interventions
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Freestyle libre
A glucose sensor (flash) which measures interstitial blood glucose every 15 minutes or on demand.
Nurse led structured intervention - hypoglycaemia education and diabetes treatment modification modification
An education programme surrounding avoidance of hypoglycaemia at baseline. Regular review (weeks 2, 4, 12 and 24) and adjustment of diabetes medications based on freestyle libre data.
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of type 2 diabetes
* Suffered an episode of severe hypoglycaemia requiring ambulance call out
* Able to provide informed written consent
Exclusion Criteria
* Currently pregnant
* Dialysis dependent renal failure
* Unable to provide informed written consent
18 Years
ALL
No
Sponsors
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Abbott Diabetes Care
INDUSTRY
University of Leeds
OTHER
Responsible Party
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Ramzi Ajjan
Professor of metabolic medicine
Principal Investigators
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Ramzi A Ajjan, PHD
Role: PRINCIPAL_INVESTIGATOR
University of Leeds
Locations
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Diabetes centre, St James hospital
Leeds, West Yorkshire, United Kingdom
Countries
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Central Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STRATUS
Identifier Type: -
Identifier Source: org_study_id
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