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临床试验/NCT03545178
NCT03545178已完成不适用

Systematic Evaluation of Continuous Glucose Monitoring Data to for the Development of Clinical Solutions

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
384
试验地点
1
主要终点
Hypoglycemia prediction (for Substudy B)

研究概览

简要总结

This study retrospectively evaluates continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) data and pursues two main objectives: First, the investigators analyze if glucose values are better controlled in the days directly before a consultation at our tertiary referral centre (so called "white coat adherence"). Second, the investigators use the collected CGM and FGM data to develop a hypoglycemia prediction model.

详细描述

Substudy A.) Presence of white coat adherence in diabetic patients:

The investigators aim at evaluating the existence of a so called "white coat adherence" with regard to diabetes control, which means that blood-glucose is better controlled in the days immediately prior to a consultation at the diabetes clinic compared to the time-period further back. To analyse this phenomenon, the investigators use continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) of diabetic patients and compare CGM-/FGM data of the last three days prior to the consultation with the CGM-/FGM data of the days 4-28 prior to the consultation, as well as the last seven days prior to the consultation with days 8-28 prior to the consultation.

Substudy B.) Retrospective data collection for the development and evaluation of a hypoglycemia prediction model:

Scope of the study is to use retrospective data for training and evaluation of a deep recurrent neural network based system for predicting the onset of hypoglycemic event at least 20 min ahead in time. The study aims to: I, assess the ability of deep learning algorithm to predict hypoglycemic events using the data collected during substudy 1. II, assess the ability of global model to be personalized using the data collected during sub-study 1. III, investigate the amount of "history" to be involved to achieve maximum performance in terms of prediction ability. IV, develop a global model, which can be easily further personalized to achieve optimum prediction performance per patient.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

入选标准

  • Diabetes mellitus
  • CGM and/or FGM available for at least 50% of the time in last 4 weeks before consultation
  • Written informed general consent for the retrospective analysis of data

排除标准

  • Pregnancy

结局指标

主要结局

Hypoglycemia prediction (for Substudy B)

时间窗: 01.01.2013 - 31.07.2018; outcome assessed at study end

Proportion of times a deep learning based algorithm can predict a hypoglycemic event (BG \<4.0 mmol/l) at least 20 min ahead in time?

Change of time in target glucose range day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

时间窗: 01.01.2013 - 31.07.2018; outcome assessed at study end

The time spent in the target glucose range from 3.9 to 10.0 mmol/l assessed by CGM/FGM.

次要结局

  • Change of average and standard deviation glucose day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)(01.01.2013 - 31.07.2018; outcome assessed at study end)
  • Change of time in hyperglycemia day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)(01.01.2013 - 31.07.2018; outcome assessed at study end)
  • Sensor wearing time day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)(01.01.2013 - 31.07.2018; outcome assessed at study end)
  • Change of mean amplitude of glucose excursion (MAGE) day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)(01.01.2013 - 31.07.2018; outcome assessed at study end)
  • Change of time above and below glucose target range day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)(01.01.2013 - 31.07.2018; outcome assessed at study end)
  • Change of coefficient of variation (CV) day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)(01.01.2013 - 31.07.2018; outcome assessed at study end)
  • Change of time in hypoglycemia day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)(01.01.2013 - 31.07.2018; outcome assessed at study end)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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