NCT06034574尚未招募不适用
A Trial Investigating the Accuracy of Continuous Glucose Monitor Systems ("Supersapiens" Abbott Libre Sense and Dexcom G6) During Exercise in People With Normal Glucose Tolerance
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- %MARD lab phase
研究概览
简要总结
A two-phase, observational trial in an exercise laboratory and a prospective real-world setting to test the hypothesis that The Libre Sense Glucose Sport device has acceptable accuracy in people with normal glucose tolerance and comparable accuracy in the range of 3.0 to 11mmol/L to clinically approved CGM in people with type 1 diabetes.
详细描述
This is two-phase trial including a research facility and home phase existing of five study related visits:
- Screening visit and CPX test (2 hrs per visit)
- three exercise sessions completed in a random order at the research facility (2 hrs per visit) plus an additional visit for people with normal glucose tolerance to undertake a glucose tolerance test
- 4 weeks of home-based exercise (3 sessions of ~60 minutes moderate intensity exercise per week) - Including one glycaemic challenge prior to a single home-based exercise session
- Final visit
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Male or female aged 18-65 years (both inclusive)
- •Body mass index 18.0-29.9 kg/m2 (both inclusive)
- •Normal glucose tolerance (measured via fasting blood glucose levels) or type 1 diabetes for greater than 1 year
- •Participants performing regular physical activity during the last 3 months prior to screening
- •Mass-specific peak oxygen consumption (VO2peak) >20 ml/kg/min
- •For participants with type 1 diabetes
- •Stable insulin regimen for 6 months
- •HbA1c ≤69mmol/mol
排除标准
- •• Enrolment in other study, except at the discretion of the Chief investigator
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Receipt of any investigational medicinal product within 1 week prior to screening in this trial
- •Suffer from or history of a life-threatening disease (i.e. cancer judged not to be in full remission except basal cell skin cancer or squamous cell skin cancer), or clinically severe diseases that directly influence the study results, as judged by the Investigator. This does not prohibit the participation of patients taking medications that influences the metabolism (e.g. statin) or cardio-respiratory system (e.g. asthma spray) as long as the therapy is stable and is not adapted throughout the run of the trial. Furthermore, it does not excluded patients how have celiac disease (or similar diseases or allergies), as long as the disease is stable, and patients are able to stay on their specific (e.g.) gluten-free diet.
- •Participant with a heart rate <35 beats per minute (bpm) at screening (after resting for 5 min in supine position)
- •Supine blood pressure at screening (after resting for 5 min in supine position) outside the range of 90-150 mmHg for systolic or 50-95 mmHg for diastolic (excluding white-coat hypertension; therefore, if a repeated measurement on a second screening Visit shows values within the range, the participant can be included in the trial). This exclusion criterion also pertains to participants being on anti-hypertensives
- •Significant abnormal ECG at screening, as judged by the Investigator
- •Any chronic (metabolic) disorder or severe disease which, in the opinion of the Investigator might jeopardise participant's safety or compliance with the protocol
- •History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
- •Participant with mental incapacity or language barriers precluding adequate understanding or cooperation or who, in the opinion of their general practitioner or the Investigator, should not participate in the trial
- •Potentially non-compliant or uncooperative during the trial, as judged by the Investigator
- •Any condition that would interfere with trial participation or evaluation of results, as judged by the Investigator
- •Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant.
结局指标
主要结局
%MARD lab phase
时间窗: 2 weeks
To assess % mean or median absolute relative difference (%MARD) of Supersapiens Abbott Libre Sense during exercise to reference capillary blood glucose (lab phase)
次要结局
- %MARD home phase(4 weeks)
研究者
研究点 (1)
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