Flash-glucose Monitoring in Sub-optimally Controlled Type 1 Diabetes (FLASH-UK)

NCT03815006 | Completed Results DMC

• 1 other identifier: B00373
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 8

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 the recommended 4-10 painful finger-stick blood glucose tests required each day for the self-management of type 1 diabetes. The purpose of this study is to determine whether flash glucose monitoring with FSL2 device will improve HbA1c over 24 weeks compared to self-monitoring of blood glucose in adults and adolescents (16 or older) with sub-optimally controlled (HbA1c 7.5% to 11%) type 1 diabetes. This is an open-label, multi-centre, randomised, parallel design study, involving a 2-week run-in period, followed by a 24-week study period during which participants will use either FSL2 or continue usual finger-stick glucose monitoring in random order. A total of up to 156 randomised participants from up to 180 recruited aged 16 years and older with T1D on insulin pump therapy or multiple daily injection therapy were recruited through diabetes clinics in participating centres. Participants will receive appropriate training to maximise the benefits of FSL2 and finger-stick glucose levels in self-management. The primary outcome is the difference in HbA1c between the two groups at 24 weeks. Secondary outcomes are time spent with glucose levels above and below target, as recorded by FSL2, and other flash glucose-based metrics. Impact on quality of life, diabetes distress, mood, needle burden, disordered eating and treatment satisfaction will also be undertaken. Relative cost-effectiveness of FSL2 device compared with self-monitoring will also be assessed from a UK NHS perspective.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• HbA1c Level at 24 Weeks

  The primary outcome is difference in HbA1c between the two groups at 24 weeks.

  24 weeks

Secondary Outcomes (30)

• HbA1c Level at 12 Weeks

  12 weeks

• Percentage With HbA1c ≤ 53 mmol/Mol (7.0%) at 12 Weeks

  12 weeks

• Percentage With HbA1c ≤ 53 mmol/Mol (7.0%) at 24 Weeks

  24 weeks

• Sensor Based - Time Spent in the Target Glucose Range Between 3.9 to 10.0 mmol/l

  24 weeks

• Sensor Based - Time Spent Below Target Glucose (<3.9mmol/l)

  24 weeks

Study Arms (2)

Free Style Libre 2 device

EXPERIMENTAL

At the start, a blood sample will be taken for the measurement of HbA1c. Training and education on the use of FSL2 will be provided by the research team. Participants will be advised to use flash glucose monitoring continuously for the next 24 weeks.

Device: Free Style Libre 2

Self-monitoring of blood glucose

NO INTERVENTION

At the start, a blood sample will be taken for the measurement of HbA1c. Masked FSL will be applied for two weeks, during the last two weeks of control period. Education will focus on using fingerstick measurement for treatment optimisation.

Interventions

Free Style Libre 2 DEVICE

FreeStyle Libre 2 (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 the recommended 4-10 painful finger-stick blood glucose tests required each day for the self-management of type 1 diabetes (T1D).

Free Style Libre 2 device

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• University Hospitals of Derby and Burton NHS Foundation Trust: collaborator
• Cambridge University Hospitals NHS Foundation Trust: collaborator
• Portsmouth Hospitals NHS Trust: collaborator
• University Hospital Birmingham NHS Foundation Trust: collaborator
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator
• University of Manchester: collaborator
• Diabetes UK: collaborator
• Clinical Trials Unit, Manchester: collaborator
• BHR Limited: collaborator
• East Suffolk and North Essex NHS Foundation Trust: collaborator
• The Adam Practice: collaborator

Study Sites (8)

The Adam Practice

Poole, Dorset, BH16 5PW, United Kingdom

Location

College of Medical and Dental Sciences University of Birmingham

Birmingham, B152TT, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, CB20QQ, United Kingdom

Location

University Hospitals of Derby and Burton NHS Foundation Trust

Derby, DE223NE, United Kingdom

Location

Ipswich Hospital

Ipswich, IP4 5PD, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, M139WL, United Kingdom

Location

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, NR47UY, United Kingdom

Location

Queen Alexandra Hospital

Portsmouth, PO63LY, United Kingdom

Location

Related Publications (3)

• Leelarathna L, Wilmot EG. Flash forward: a review of flash glucose monitoring. Diabet Med. 2018 Apr;35(4):472-482. doi: 10.1111/dme.13584. Epub 2018 Feb 27.

  PMID: 29356072 BACKGROUND

• Leelarathna L, Evans ML, Neupane S, Rayman G, Lumley S, Cranston I, Narendran P, Barnard-Kelly K, Sutton CJ, Elliott RA, Taxiarchi VP, Gkountouras G, Burns M, Mubita W, Kanumilli N, Camm M, Thabit H, Wilmot EG; FLASH-UK Trial Study Group. Intermittently Scanned Continuous Glucose Monitoring for Type 1 Diabetes. N Engl J Med. 2022 Oct 20;387(16):1477-1487. doi: 10.1056/NEJMoa2205650. Epub 2022 Oct 5.

  PMID: 36198143 DERIVED

• Wilmot EG, Evans M, Barnard-Kelly K, Burns M, Cranston I, Elliott RA, Gkountouras G, Kanumilli N, Krishan A, Kotonya C, Lumley S, Narendran P, Neupane S, Rayman G, Sutton C, Taxiarchi VP, Thabit H, Leelarathna L. Flash glucose monitoring with the FreeStyle Libre 2 compared with self-monitoring of blood glucose in suboptimally controlled type 1 diabetes: the FLASH-UK randomised controlled trial protocol. BMJ Open. 2021 Jul 14;11(7):e050713. doi: 10.1136/bmjopen-2021-050713.

  PMID: 34261691 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

please see NEJM publication for details https://www.nejm.org/doi/full/10.1056/NEJMoa2205650

Results Point of Contact

• Title: Dr Lala Leelarathna
• Organization: Manchester University NHS Foundation Trust

lalantha.leelarathna@manchester.ac.uk

01612766706

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 24, 2019
• Study Start: January 9, 2020
• Primary Completion: October 10, 2021
• Study Completion: October 10, 2021
• Last Updated: October 16, 2023
• Results First Posted: October 16, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 6 months and ending 3 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal not overlapping with any planned secondary publications from the research team.

Locations

GB (8)