Are Todays Continuous Glucose Monitoring Precise and Can They be Used to Reveal and Reduce Glycaemic Variability?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 472
- 主要终点
- Optimal Time Shift of Continuous Glucose Monitoring Measurements
研究概览
简要总结
Use of devices for continuous monitoring of the blood sugar is valuable for people with diabetes to understand their disease and to help prevent low blood sugar. Furthermore, continuous monitoring should be used in drug development to evaluate efficacy and safety. However, the devices have been criticised for being too inaccurate. This investigation sought to reveal the inaccuracies of current devices and to assess the subsequent usability related to the mentioned use cases.
详细描述
The following study is an exploratory investigation of continuous glucose monitoring based on data from a completed Novo Nordisk A/S clinical trial. Please refer to ClinicalTrials.gov Identifier: NCT02825251.
Continuous Glucose Monitoring (CGM) provides an interstitial glucose reading every 5 minutes and is thus a powerful and important tool to identify glycaemic variability in people with diabetes. CGM is valuable for people with diabetes to understand their glucose metabolism and it has the potential to be used for detection and prediction of glycaemic excursions, such as, the potentially fatal and inevitable events of hypoglycaemia, or even as a component in the holy grail of diabetes technology; the artificial pancreas.
However, CGM has been criticised for being inaccurate and unreliable, amongst others, due to the physiological and a device-related delay between plasma glucose (PG) and interstitial glucose (IG). Nevertheless, CGM keeps on being popular and in February 2017 an international consensus was established at the Advanced Technologies & Treatments for Diabetes (ATTD) congress that even considers CGM data as a valuable and meaningful end point to be used in clinical trials of new drugs and devices for diabetes treatment where accuracy is of high importance.
The above mentioned use cases entail that the CGM data are accurate. Therefore, the first part of this research proposal is to investigate whether the newest state-of-the-art CGM devices used in Novo Nordisk trials are in fact accurate. Based on these results, it is investigated to which degree glycaemic variability can be revealed.
To investigate the accuracy of CGM, mean absolute relative difference (MARD) will be calculated and presented and the impact of the delay assessed by time shifting CGM measurements. Furthermore, correlation analyses, between for example, PG and first derivative of IG, will be performed to try to understand when CGM devices tend to measure inaccurate. Lastly, machine learning and/or deep learning approaches will be utilised to reveal glycaemic patterns and to detect/predict outcomes, such as, hypoglycaemia.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age at least 18 years at the time of signing the informed consent
- •Diagnosed with T1DM (Type 1 Diabetes Mellitus) (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) equal or above 1 year prior to the day of screening
- •Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754), Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least six months prior to screening and willing to stay on the same pump model throughout the trial (if the model is changed the change should not exceed 7 consecutive days.)
- •HbA1c (glycosylated haemoglobin) 7.0-9.0% (53-75 mmol/mol) as assessed by central laboratory at screening
- •Body mass index (BMI) below or equal to 35.0 kg/m^2 at screening
- •Ability and willingness to take at least 3 daily meal-time insulin bolus infusions every day throughout the trial
排除标准
- •Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
- •Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- •History of hospitalization for ketoacidosis below or equal to 180 days prior to the day of screening
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
- •Any condition which, in the opinion of the Investigator, might jeopardise a Subject's safety or compliance with the protocol
结局指标
主要结局
Optimal Time Shift of Continuous Glucose Monitoring Measurements
时间窗: 16 weeks
Continuous glucose monitoring (CGM) measurements are delayed compared to blood glucose. The CGM signal is time-shifted -1 minute at a time and the mean absolute difference between CGM and blood glucose measurements are calculated at each step. The lowest mean absolute difference depicts the optimal time shift in minutes. The resultant mean absolute relative difference is provided as outcome. Publication reference: https://doi.org/10.1177/1932296819848721
次要结局
- Area Under the Receiver Operating Characteristics Curve of the Hypoglycemia Prediction(16 weeks)
研究者
Peter Vestergaard
Professor
Aalborg University Hospital