Status:
COMPLETED
Flash-glucose Monitoring in Sub-optimally Controlled Type 1 Diabetes (FLASH-UK)
Lead Sponsor:
Manchester University NHS Foundation Trust
Collaborating Sponsors:
University Hospitals of Derby and Burton NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
FreeStyle Libre (FSL2) is a novel glucose monitoring device (Flash glucose monitoring) in the form of a disc worn on the arm for 14 days, and a hand-held reader which is designed to largely replace th...
Detailed Description
Study Design: An open-label, multi-centre, randomised, parallel study, in adults and adolescents (16 years and older) with type 1 diabetes and sub-optimal glycaemic control (HbA1c 7.5% to 11%), eithe...
Eligibility Criteria
Inclusion
- The participant is ≥16 years old
- The participant has type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative if duration of diabetes is \< 1 years
- Participant is treated with insulin pump or multiple daily injection for at least 12 weeks and no plans to change treatment modality during next 28 weeks
- The participant is literate in English for safe study conduct
- Screening HbA1c ≥ 7.5% (58.5mmol/mol) and ≤ 11% (97 mmol/mol) based on analysis from local laboratory
- The participant is willing to wear study glucose sensor and scan for glucose levels at regular intervals
- The participant is willing to follow study specific instructions and improve glucose control
- Female participants of child bearing age should be on effective contraception and must have a negative blood or urine pregnancy test at screening.
- The participant adopting a virtual pathway through the trial is able and willing to post study devices, questionnaires and blood collection kits back to the research team or to the laboratory using pre-paid postal services.
- The participant adopting a virtual pathway through the trial has internet connection, appropriate videoconferencing software and supporting devices to undertake video consultations where necessary.
Exclusion
- Key exclusion criteria:
- Non-type 1 diabetes mellitus including those secondary to chronic disease
- Any other physical disease or people with known severe mental illness (psychotic disorder, bipolar disorder, dementia, substance and alcohol dependence, learning disabilities, depression with active suicidal ideation) which are likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
- Current users of real-time glucose monitoring sensors or flash-glucose monitoring for more than 4 weeks within last 12 weeks
- Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, SGLT2 inhibitors, GLP-1 agonists, Pramlinatide, non-selective beta-blockers and MAO inhibitors etc.(patients on stable metformin is not an exclusion)
- Known or suspected allergy against insulin
- Severe visual impairment
- Complete loss of hypoglycaemia awareness
- Significant renal impairment eGFR\<30 within previous one year or on dialysis or active retinopathy (defined as presence of maculopathy or proliferative changes) as judged by the investigator
- More than one episode of severe hypoglycaemia as defined by American Diabetes Association (30) in preceding 24 weeks
Key Trial Info
Start Date :
January 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2021
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT03815006
Start Date
January 9 2020
End Date
October 10 2021
Last Update
October 16 2023
Active Locations (8)
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1
The Adam Practice
Poole, Dorset, United Kingdom, BH16 5PW
2
College of Medical and Dental Sciences University of Birmingham
Birmingham, United Kingdom, B152TT
3
Addenbrooke's Hospital
Cambridge, United Kingdom, CB20QQ
4
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, United Kingdom, DE223NE