N/A
Completed N=156
Flash-glucose Monitoring in Sub-optimally Controlled Type 1 Diabetes (FLASH-UK)
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT03815006 ↗
Enrolled (actual)
156
Serious AEs
2.6%
Results posted
Oct 2023
Primary outcomePrimary: HbA1c Level at 24 Weeks — 62.8; 67.7 mmol/mol
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Level at 24 Weeks |
62.8; 67.7 | — |
| SECONDARY HbA1c Level at 12 Weeks |
— | — |
| SECONDARY Percentage With HbA1c ≤ 53 mmol/Mol (7.0%) at 12 Weeks |
— | — |
| SECONDARY Percentage With HbA1c ≤ 53 mmol/Mol (7.0%) at 24 Weeks |
— | — |
| SECONDARY Sensor Based - Time Spent in the Target Glucose Range Between 3.9 to 10.0 mmol/l |
— | — |
| SECONDARY Sensor Based - Time Spent Below Target Glucose (<3.9mmol/l) |
— | — |
| SECONDARY Sensor Based - Time Spent Above Target Glucose (10.0 mmol/l) |
— | — |
| SECONDARY Sensor Based - Average Glucose Levels |
— | — |
| SECONDARY Sensor Based - Standard Deviation Glucose Levels |
— | — |
| SECONDARY Sensor Based - Coefficient of Variation Glucose Levels |
— | — |
| SECONDARY Sensor Based - Time With Sensor Glucose Levels < 3.5 mmol/l |
— | — |
| SECONDARY Sensor Based - Time With Sensor Glucose Levels < 2.8 mmol/l |
— | — |
| SECONDARY Sensor Based - Time With Sensor Glucose Levels in the Significant Hyperglycaemia |
— | — |
| SECONDARY Sensor Based - AUC of Glucose Below 3.0mmol/l |
— | — |
| SECONDARY Total Daily Average Insulin Dose |
— | — |
| SECONDARY Daily Average Basal Insulin Dose |
— | — |
| SECONDARY Daily Average Bolus Dose |
— | — |
| SECONDARY Average Number of Boluses of Rapid Acting Insulin |
— | — |
| SECONDARY Number of Freestyle Libre Scans Per Day |
— | — |
| SECONDARY Frequency of Severe Hypoglycaemic Episodes |
— | — |
| SECONDARY Frequency of Significant Ketosis Events |
— | — |
| SECONDARY Nature and Severity of Other Adverse Events |
— | — |
| SECONDARY Type 1 Diabetes Distress Scale Score |
— | — |
| SECONDARY EQ-5D-5L Quality of Life Questionnaire Score |
— | — |
| SECONDARY Patient Health Questionnaire Score |
— | — |
| SECONDARY Diabetes Fear of Injecting and Self-Testing Questionnaire Score |
— | — |
| SECONDARY The Revised Diabetes Eating Problem Survey Score |
— | — |
| SECONDARY Average Number of Days of Libre Usage Per Week |
— | — |
| SECONDARY Diabetes Treatment Satisfaction Questionnaire Score |
— | — |
| SECONDARY Glucose Monitoring Satisfaction Survey Score |
— | — |
Eligibility 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 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 Criteria
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
Data sourced from ClinicalTrials.gov (NCT03815006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.