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

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ClinicalTrials.gov Identifier: NCT03815006
Recruitment Status : Not yet recruiting
First Posted : January 24, 2019
Last Update Posted : January 24, 2019
Sponsor:
Collaborators:
Derby Hospitals NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
Portsmouth Hospitals NHS Trust
University Hospital Birmingham NHS Foundation Trust
Norfolk and Norwich University Hospitals NHS Foundation Trust
University of Manchester
Diabetes UK
Manchester Clinical Trials Unit
BHR Limited
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

Brief Summary:

FreeStyle Libre (FSL) 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 FSL 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 FSL or continue usual finger-stick glucose monitoring in random order. A total of up to 160 participants (aiming for 128 completed participants) aged 16 years and older with T1D on insulin pump therapy or multiple daily injection therapy will be recruited through diabetes clinics in participating centres.

Participants will receive appropriate training to maximise the benefits of FSL 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 FSL, 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 FSL device compared with self-monitoring will also be assessed from a UK NHS perspective.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: Free Style Libre Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-centre, Randomised, Parallel Design Study to Assess the Efficacy of Flash Glucose Monitoring in Adults With Type 1 Diabetes
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Free Style Libre device
At the start, a blood sample will be taken for the measurement of HbA1c. Training and education on the use of FSL 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
FreeStyle Libre (FSL) 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).

No Intervention: Self-monitoring of blood glucose
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.



Primary Outcome Measures :
  1. HbA1c Level at 24 weeks [ Time Frame: 24 weeks ]
    The primary outcome is difference in HbA1c between the two groups at 24 weeks.


Secondary Outcome Measures :
  1. HbA1c Level at 12 weeks [ Time Frame: 12 weeks ]
    This is the difference in HbA1c between the two groups at 12 weeks

  2. Percentage with HbA1c ≤ 53 mmol/mol (7.0%) at 12 weeks [ Time Frame: 12 weeks ]
    This is the comparison between arms of percentage with HbA1c ≤ 53 mmol/mol (7.0%) at 12 weeks

  3. Percentage with HbA1c ≤ 53 mmol/mol (7.0%) at 24 weeks [ Time Frame: 24 weeks ]
    This is the comparison between arms of percentage with HbA1c ≤ 53 mmol/mol (7.0%) at 24 weeks

  4. Sensor based - Time spent in the target glucose range between 3.9 to 10.0 mmol/l [ Time Frame: 24 weeks ]
    Time spent in the target glucose range between 3.9 to 10.0 mmol/l (70 to 180mg/dl).

  5. Sensor based - Time spent below target glucose (<3.9mmol/l) [ Time Frame: 24 weeks ]
    Time spent below target glucose (<3.9mmol/l) (<70mg/dl)

  6. Sensor based - Time spent above target glucose (10.0 mmol/l) [ Time Frame: 24 weeks ]
    Time spent above target glucose (10.0 mmol/l) (180 mg/dl)

  7. Sensor based - Average glucose levels [ Time Frame: 24 weeks ]
    Average glucose levels

  8. Sensor based - Standard deviation glucose levels [ Time Frame: 24 weeks ]
    Standard deviation glucose levels

  9. Sensor based - Coefficient of variation glucose levels [ Time Frame: 24 weeks ]
    Coefficient of variation glucose levels

  10. Sensor based - time with sensor glucose levels < 3.5 mmol/l [ Time Frame: 24 weeks ]
    The time with sensor glucose levels < 3.5 mmol/l (63 mg/dl)

  11. Sensor based - time with sensor glucose levels < 3.5 mmol/l [ Time Frame: 24 weeks ]
    The time with sensor glucose levels < 3.0 (54mg/dl)

  12. Sensor based - time with sensor glucose levels < 2.8 mmol/l [ Time Frame: 24 weeks ]
    The time with sensor glucose levels < 2.8 mmol/l (50 mg/dl)

  13. Sensor based - time with sensor glucose levels in the significant hyperglycaemia [ Time Frame: 24 weeks ]
    The time with sensor glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l) (300mg/dl)

  14. Sensor based - AUC of glucose below 3.0mmol/l [ Time Frame: 24 weeks ]
    AUC of glucose below 3.0mmol/l (54mg/dl)

  15. Total daily average insulin dose [ Time Frame: 24 weeks ]
    Comparison between arms of Total daily average insulin dose

  16. Daily average basal insulin dose [ Time Frame: 24 weeks ]
    Comparison between arms of Daily average basal insulin dose

  17. Daily average bolus dose [ Time Frame: 24 weeks ]
    Comparison between arms of Daily average bolus dose

  18. Average number of boluses of rapid acting insulin [ Time Frame: 24 weeks ]
    Average number of boluses of rapid acting insulin per day

  19. Number of Freestyle Libre scans per day [ Time Frame: 24 weeks ]
    Number of Freestyle Libre scans per day in the intervention arm only

  20. Frequency of severe hypoglycaemic episodes [ Time Frame: 24 weeks ]
    Frequency of severe hypoglycaemic episodes as defined by American Diabetes Association

  21. Frequency of significant ketosis events [ Time Frame: 24 weeks ]
    Frequency of significant ketosis events (plasma ketones >3mmol/l)

  22. Nature and severity of other adverse events [ Time Frame: 24 weeks ]
    Nature and severity of other adverse events.

  23. Type 1 Diabetes Distress Scale Score [ Time Frame: 24 weeks ]
    Type 1 Diabetes Distress Scale score compared between arms

  24. EQ-5D-5L Quality of Life questionnaire Score [ Time Frame: 24 weeks ]
    EQ-5D-5L Quality of Life questionnaire

  25. Patient Health Questionnaire Score [ Time Frame: 24 weeks ]
    Patient Health Questionnaire: score of 5-9 would be minimal symptoms. any score large than 20 would be categorised as severe major depression

  26. Diabetes fear of injecting and self‐testing questionnaire Score [ Time Frame: 24 weeks ]
    Diabetes fear of injecting and self‐testing questionnaire: 15 questions, 6 for Fear of Self injecting, 9 for fear of self testing.

  27. The revised Diabetes Eating Problem Survey score [ Time Frame: 24 weeks ]
    The revised Diabetes Eating Problem Survey

  28. Average number of days of Libre usage per week [ Time Frame: 24 weeks ]
    Average number of days of usage per week

  29. Diabetes Treatment Satisfaction Questionnaire score [ Time Frame: 24 weeks ]
    Diabetes Treatment Satisfaction Questionnaire

  30. Glucose Monitoring Satisfaction Survey score [ Time Frame: 24 weeks ]
    Glucose Monitoring Satisfaction Survey: 15 questions ranging from 1-5.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 literate in English
  • 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.

Exclusion Criteria:

Key exclusion criteria:

  • Non-type 1 diabetes mellitus including those secondary to chronic disease
  • Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
  • Untreated hypothyroidism
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815006


Contacts
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Contact: Lalantha Leelarathna, PhD Lalantha.Leelarathna@mft.nhs.uk
Contact: Diabetes Research Team 00441612766102

Locations
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United Kingdom
College of Medical and Dental Sciences University of Birmingham Not yet recruiting
Birmingham, United Kingdom, B152TT
Contact: Parth Narendran, MD    01214143006    p.narendran@bham.ac.uk   
Addenbrooke's Hospital Not yet recruiting
Cambridge, United Kingdom, CB20QQ
Contact: Mark Evans, MD    +441223336994    mle24@cam.ac.uk   
University Hospitals of Derby and Burton NHS Foundation Trust Not yet recruiting
Derby, United Kingdom, DE223NE
Contact: Emma Wilmot, PhD    +441332787696    emma.g.wilmot@gmail.com   
Manchester University NHS Foundation Trust Not yet recruiting
Manchester, United Kingdom, M139WL
Contact: Lalantha Leelarathna, PhD       Lalantha.Leelarathna@mft.nhs.uk   
Contact: R&D Office       R&D.Applications@mft.nhs.uk   
Principal Investigator: Lalantha Leelarathna, MD         
Norfolk and Norwich University Hospitals NHS Foundation Trust Not yet recruiting
Norwich, United Kingdom, NR47UY
Contact: Sankalpa Neupane, MD    01603286312    sankalpa.neupane@nnuh.nhs.uk   
Queen Alexandra Hospital Not yet recruiting
Portsmouth, United Kingdom, PO63LY
Contact: Iain Cranston, MD    02392286044    Iain.cranston@porthosp.nhs.uk   
Sponsors and Collaborators
Manchester University NHS Foundation Trust
Derby Hospitals NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
Portsmouth Hospitals NHS Trust
University Hospital Birmingham NHS Foundation Trust
Norfolk and Norwich University Hospitals NHS Foundation Trust
University of Manchester
Diabetes UK
Manchester Clinical Trials Unit
BHR Limited

Publications:
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Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03815006     History of Changes
Other Study ID Numbers: B00373
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases