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临床试验/NCT03885362
NCT03885362已完成不适用

Assessment of the Accuracy of Continuous Glucose Sensors in People With Diabetes Undergoing Haemodialysis

Imperial College London1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年12月11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
40
试验地点
1
主要终点
MARD between G6 and YSI

研究概览

简要总结

The purpose of the study is to assess the accuracy of the Dexcom G6 CGM system and the Abbott FreeStyle Libre flash system compared to the reference standard YSI (Yellow Spring Instruments) glucose in people with diabetes undergoing haemodialysis. The Dexcom G6 is a continuous glucose monitoring system that gives blood glucose values in real-time and includes alarms if the glucose is very low or high. The Abbott FreeStyle ibre flash system is an intermittent glucose monitor that shows the blood glucose values when it is waved near the sensor and does not include alarms. The YSI glucose analysis will take place as a normal part of haemodialysis, by testing blood glucose levels during the haemodialysis session. The study will last 28 days per participant

详细描述

Diabetic nephropathy is the leading cause of end-stage renal failure (ESRF), representing approximately 40% of people requiring long-term renal replacement therapy and maintenance haemodialysis [1]. Mortality and morbidity within this cohort is high, with the predominant cause being cardiovascular disease (CVD) [2]. Glycaemic control in many haemodialysis dependent patients with diabetes is poor and may lead to additional renal complications, including high interdialytic weight gain, electrolyte imbalance, and amputations [3]. Current clinical guidance is centred around the prevention of hyperglycaemia and microvascular complications of diabetes.

Glucose self-management is particularly challenging due to cyclical changes in insulin sensitivity and circulating insulin concentrations. Hypoglycemia is common due to impaired renal gluconeogenesis, malnutrition, and the increased half-life of insulin and hypoglycemic agents [4, 5]. Additionally, people with chronic kidney disease and diabetes may have other diabetes complications such as retinopathy, neuropathy, and impaired awareness of hypoglycaemia, which can make self-management more difficult.

Overall assessment of glycaemic control is also more complex as classical markers of glycemic control (i.e. HbA1c and fructosamine) may be misleading due to the variable underestimation of glycaemia resulting from analytical interferences, shortened half-life of red blood cells and abnormal albumin level [6-8]. Further limitations of HbA1c is that it is not informative regarding glycemic control on the days on and off dialysis, and intra-day glycaemic variability.

Frequent capillary blood glucose tests or self-monitoring of blood glucose (SMBG) is the traditional and one of the most effective ways to track an individuals' blood glucose levels. Real-time continuous glucose monitoring (CGM) has been shown to improve overall glucose control, reduce hypoglycaemia in people with an HbA1c <7.0%, and may reduce severe hypoglycaemia [9-11]. In addition, they provide alert and alarm features for hypo- and hyperglycaemia, and for times of rapid glucose change.

Flash glucose monitoring does not provide real-time data with alerts and alarms, but allows users to retrospectively review the preceding 8 hours of continuous glucose data, along with a contemporary estimated blood glucose value and trend line. The system consists of a subcutaneous sensor placed on the back of the upper arm, which measures glucose in the interstitial fluid every minute. The glucose data are made available when the user chooses to swipe the reader over the sensor.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

盲法说明

Blinded CGM but not Libre

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults >18 years of age
  • Diabetes, with insulin treatment for over 6 months or on sulphonylureas
  • Chronic kidney disease requiring haemodialysis three times per week

排除标准

  • Pregnant or planning pregnancy
  • Breastfeeding
  • Enrolled in other clinical trials
  • Have active malignancy or under investigation for malignancy
  • Severe visual impairment
  • Reduced manual dexterity
  • Unable to participate due to other factors, as assessed by the Chief Investigators

结局指标

主要结局

MARD between G6 and YSI

时间窗: 28 days

Mean absolute relative difference between Dexcom G6 and YSI glucose during haemodialysis

MARD between Libre and YSI

时间窗: 28 days

Mean absolute relative difference between Dexcom G6 and YSI glucose during haemodialysis

次要结局

  • MARD for Libre and YSI <3.9mmol/L(28 days)
  • MARD for G6 and YSI <3.9mmol/L(28 days)
  • MARD for G6 and YSI 3.9-10mmol/L(28 days)
  • Severe hypoglycaemia(28 days)
  • DKA(28 days)
  • Missing glucose data(28 days)
  • HbA1c(28 days)
  • MARD for G6 and YSI >10mmol/L(28 days)
  • MARD for Libre and YSI 24hr post(24 hours)
  • Sensor failure(28 days)
  • MARD for Libre and YSI 3.9-10mmol/L(28 days)
  • MARD for Libre and YSI >10mmol/L(28 days)
  • MARD for Libre and YSI 24hr pre(24 hours)
  • MARD for G6 and YSI 24hr post(24 hours)
  • CEG analysis G6 and YSI(28 DAYS)
  • CEG analysis Libre and YSI(28 DAYS)
  • MARD for G6 and YSI 24hr pre(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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