An Open-label, Multi-centre, Randomised, Parallel Design Study to Assess the Efficacy of Flash Glucose Monitoring in Adults With Sub-optimally Controlled Type 1 Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 16
- 主要终点
- HbA1c Level at 24 Weeks
研究概览
简要总结
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.
详细描述
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%), either on insulin pump treatment or multiple daily injections, contrasting flash glucose monitoring using FreeStyle Libre 2 device with traditional finger-stick glucose monitoring for 24 weeks. Expecting approximately 15% to 20% dropout rate recruitment will aim for 180 participants aiming for 156 randomised and 128 completed participants.
Participant Recruitment:
This is a UK multi-centre and recruitment will take place at the following centres:
- Diabetes Centres within Manchester University Foundation Trust
- Royal Derby Hospital, Derby
- Queen Elizabeth Hospital, Birmingham
- Addenbrookes Hospital, Cambridge
- Norfolk and Norwich University Hospital, Norwich
- Queen Alexandra Hospital, Portsmouth
- Ipswich Hospital
- The Adam Practice, Dorset
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
HbA1c Level at 24 Weeks
时间窗: 24 weeks
The primary outcome is difference in HbA1c between the two groups at 24 weeks.
次要结局
- Nature and Severity of Other Adverse Events(24 weeks)
- EQ-5D-5L Quality of Life Questionnaire Score(24 weeks)
- The Revised Diabetes Eating Problem Survey Score(24 weeks)
- Sensor Based - Time Spent in the Target Glucose Range Between 3.9 to 10.0 mmol/l(24 weeks)
- Frequency of Significant Ketosis Events(24 weeks)
- Sensor Based - Time Spent Above Target Glucose (10.0 mmol/l)(24 weeks)
- Sensor Based - Average Glucose Levels(24 weeks)
- Sensor Based - Time With Sensor Glucose Levels < 2.8 mmol/l(24 weeks)
- Sensor Based - AUC of Glucose Below 3.0mmol/l(24 weeks)
- Daily Average Basal Insulin Dose(24 weeks)
- Sensor Based - Time Spent Below Target Glucose (<3.9mmol/l)(24 weeks)
- Type 1 Diabetes Distress Scale Score(24 weeks)
- Patient Health Questionnaire Score(24 weeks)
- Sensor Based - Standard Deviation Glucose Levels(24 weeks)
- Sensor Based - Coefficient of Variation Glucose Levels(24 weeks)
- Sensor Based - Time With Sensor Glucose Levels in the Significant Hyperglycaemia(24 weeks)
- Number of Freestyle Libre Scans Per Day(24 weeks)
- 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)
- Average Number of Boluses of Rapid Acting Insulin(24 weeks)
- Frequency of Severe Hypoglycaemic Episodes(24 weeks)
- Diabetes Treatment Satisfaction Questionnaire Score(24 weeks)
- Daily Average Bolus Dose(24 weeks)
- Total Daily Average Insulin Dose(24 weeks)
- Diabetes Fear of Injecting and Self-Testing Questionnaire Score(24 weeks)
- Average Number of Days of Libre Usage Per Week(24 weeks)
- Glucose Monitoring Satisfaction Survey Score(24 weeks)
- Sensor Based - Time With Sensor Glucose Levels < 3.5 mmol/l(24 weeks)