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临床试验/NCT03748433
NCT03748433终止不适用

Assessment of the Impact of Real-Time Continuous Glucose Monitoring on People Presenting With Severe Hypoglycaemia

Imperial College London1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年1月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
35
试验地点
1
主要终点
Time Spent in Hypoglycaemia

研究概览

简要总结

This study aims to assess the impact of real-time continuous glucose monitoring on the frequency, duration, awareness and severity of hypoglycaemia in people with type 1 diabetes and a recent history of severe hypoglycaemia, compared to usual care.

详细描述

Type 1 diabetes (T1DM), which affects 300,000 in the UK, is characterised by autoimmune destruction of the pancreatic beta cells, leading to absolute deficiency of insulin. Management of T1DM requires exogenous insulin administration, aiming for glucose concentrations as close to physiological values as possible. Intensive management of T1DM improves glucose control and reduces the risk of microvascular diabetes complications and cardiovascular disease1. In the UK diabetes consumes more than 10% of the National Health Service budget 2 and in the USA a relatively greater amount is spent on type 1 compared with type 2 diabetes (8.6% of the diabetes budget compared with 5.6% of diabetes prevalence)3. Medication and insulin pump therapy accounts for less than 10% of diabetes expenditure with the majority of costs incurred in the treatment of complications4.

Optimal control remains challenging to achieve and intensive insulin treatment increases the risk of severe hypoglycaemia, with lower glucose values also associated with an increased frequency and severity of moderate hypoglycaemia5, 6. Severe hypoglycaemia is defined as any episode of hypoglycaemia requiring the assistance of a third party actively to treat. Hypoglycaemia is associated with morbidity and even mortality, and places a financial burden on health systems.

Severe hypoglycaemia costs £13million per year in NHS costs7. Between 4 and 10% of deaths in people with type 1 diabetes are attributed to hypoglycaemia and the risk of severe hypoglycaemia increases 6-fold in people with impaired awareness of hypoglycaemia. Avoidance of hypoglycaemia is associated with restoration of hypoglycaemia awareness and this may be enabled by the use of continuous glucose monitoring.

In type 1 diabetes real-time continuous glucose monitoring (CGM) improves overall glucose control in all age groups when used continuously, reduces hypoglycaemia in people with an HbA1c <7.0%, and may reduce severe hypoglycaemia8-10.

The predictive Low-Glucose suspend (PLGS) feature in sensor augmented insulin pumps (SAP) automatically reduces insulin delivery when trends in CGM glucose concentrations predict future hypoglycaemia, and significantly reduces hypoglycaemia without rebound hyperglycaemia compared to SAP without PLGS11.

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

入选标准

  • •PRE-REGISTRATION EVALUATIONS
  • •Episode of severe hypoglycaemia
  • •Age >18 years
  • •Diagnosis of type 1 diabetes
  • •INCLUSION CRITERIA
  • •Adults over 18 years of age
  • •Severe hypoglycaemia requiring ambulance call-out or emergency department attendance within 2 weeks
  • •Type 1 diabetes confirmed on the basis of clinical features
  • •Type 1 diabetes for greater than 3 years

排除标准

  • •Use of CGM within the last 6 months (except short periods of diagnostic blinded use under clinic supervision). Prior use of Abbott FreeStyle Libre Device is permitted.
  • •Use of pre-mixed insulin
  • •No access to smartphone or computer
  • •Pregnant or planning pregnancy
  • •Breastfeeding
  • •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
  • •WITHDRAWAL CRITERIA
  • •Participants will be withdrawn if their ability to give informed consent is impaired. Participants will also be withdrawn, at the chief investigators discretion, if glucose control is negatively impacted by the use of either intervention.

研究组 & 干预措施

Continuous Glucose Monitoring (CGM)

Experimental

The RT CGM group will receive a Dexcom G6 transmitter and sensors, as well as a structured education refresher focusing on hypoglycaemia avoidance, recognition, and management.

干预措施: Dexcom G6 CGM (Device)

Self Monitoring Blood Glucose (SMBG)

No Intervention

The SMBG group will additionally undergo blinded CGM at weeks 1 and 2, weeks 4 to 6 and weeks 9 to 12 using the Dexcom G6 system. Participants in this group will be shown how to insert the Dexcom G6 at the first clinic visit and sensors provided so they can do this at home.

Continuous Subcutaneous Insulin Infusion (CSII)

Experimental

All participants will be re-consented with the choice to continue using RT-CGM for a further 16 weeks or be re-randomised to either receive the Tandem t:slim X2 insulin pump or RT-CGM. Participants randomised to the Tandem t:slim X2 group will be proficiently trained to safely use the Tandem t:slim X2 insulin pump. All participants (Tandem t:slim X2 and RT-CGM) will be provided with Dexcom G6 real time CGM transmitters and sensors for the 16-week second extension phase.

干预措施: Dexcom G6 CGM (Device)

Continuous Subcutaneous Insulin Infusion (CSII)

Experimental

All participants will be re-consented with the choice to continue using RT-CGM for a further 16 weeks or be re-randomised to either receive the Tandem t:slim X2 insulin pump or RT-CGM. Participants randomised to the Tandem t:slim X2 group will be proficiently trained to safely use the Tandem t:slim X2 insulin pump. All participants (Tandem t:slim X2 and RT-CGM) will be provided with Dexcom G6 real time CGM transmitters and sensors for the 16-week second extension phase.

干预措施: Tandem t:slim X2 Insulin Pump (Device)

结局指标

主要结局

Time Spent in Hypoglycaemia

时间窗: 12 weeks

Percentage time spent in hypoglycaemia (\<3.0mmol/L, 55mg/dL)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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