Type 2 Diabetes Exemplar (T2DEx): A Remote Care Service for North West London
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 7
- 主要终点
- Number of Deaths
研究概览
简要总结
The aim of T2DEx is to assess the feasibility, usability, acceptability, cost-effectiveness and safety of a digital support service for people in North West London at high risk of developing complications from Type 2 Diabetes Mellitus (T2DM).
详细描述
The Type 2 Diabetes Exemplar Programme has been designed as a collaborative effort through partners from the Discover-NOW Health Data Research Hub in North West London (NWL). The remote care service is being used in primary care to demonstrate how data and technology can improve health outcomes for people living with T2DM. The service has been designed via a cross-industry collaboration between North West London Clinical Commissioning Groups (NWL CCGs), AstraZeneca, Imperial College Health Partners and Huma. The service will be offered for patients at high risk of developing complications from T2DM (such as heart attack and stroke) and will combine video group consultations, remote monitoring via a smartphone app, and educational content such as lifestyle and diet advice.
This service seeks to strengthen population health management by providing better-tailored services and proactive interventions, particularly among population groups more at risk of the adverse impacts of COVID-19. Mortality risk from COVID-19 is approximately 25% higher in patients with T2DM and shielding has resulted in reduced primary care appointments for patients with T2DM. This has created an immediate need for primary care to adapt to provide care remotely to people with T2DM. Digital-first remote pathways could make care more accessible while finding time and cost efficiencies. By combining video group consultations and remote monitoring, we can inform the patient-clinician conversation making remote care in group settings safer, efficient and more personalised.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 是
入选标准
- •Patients over the age of 18 with the capacity to give consent
- •Patients with 'high risk' OR 'very high risk' T2DM as defined by:
- •Very high risk - T2DM with existing ASCVD OR T2DM without ASCVD but with any 3 of the following:
- •HbA1c >58
- •SBP >140
- •Non-HDL >3.35 or LDL-C >2.5
- •Nephropathy (eGFR <45, or Urine ACR >3)
- •Retinopathy
- •Neuropathy (including moderate/high risk feet, previous foot ulceration and erectile dysfunction)
- •Currently smoking
- •High risk - T2DM without ASCVD but with any 2 of the following:
- •HbA1c > 58
- •SBP >140
- •Non-HDL >3.35 or LDL-C >2.5
- •Nephropathy: eGFR <45 or Urine ACR >3
- •Retinopathy
- •Neuropathy (including moderate/high risk feet, previous foot ulceration and erectile dysfunction)
- •Currently smoking
- •Black, Asian and minority ethic (BAME) status
排除标准
- •Participants too ill to participate in the study (i.e., presence of a life-threatening condition, expected survival less than 3 months, clinically unstable)
- •Participants who have previously participated in efforts that have informed the design of this research.
- •Participant without access to a smartphone.
- •Non-English language (the remote monitoring technology currently does not support additional languages).
- •Visual disability (the remote monitoring technology currently does not natively support visual assistance).
- •Active severe mental illness (SMI).
- •Alcohol / drug abuse.
- •Severe frailty (identified via the Electronic Frailty Index - eFI).
- •Housebound / living in nursing home.
- •Currently on the REWIND Programme (a NWL total diet replacement programme for patients with type-2 diabetes).
结局指标
主要结局
Number of Deaths
时间窗: 12 weeks
Number of Participants With Emergency Department Admissions
时间窗: 12 weeks
Blood Pressure Measurements Recorded
时间窗: 12 weeks
Number of participants entering at least one blood pressure measurement
Number of Diabetes Distress Scale Scores Recorded
时间窗: 12 weeks
Number of participants entering at least one DDS measurement
Video Group Consultation Sessions Attended
时间窗: 12 weeks
the number of participants attending at least one VGC
Number of Weight Measurements Recorded
时间窗: 12 weeks
Number of participants entering at least one weight measurement
Blood Glucose Measurements Recorded
时间窗: 12 weeks
Number of participants entering at least one measurement
% Participants Downloading Huma App
时间窗: 12 weeks
Number of Participants With Hospital Admissions
时间窗: 12 weeks
次要结局
- Change in HbA1c(6 months)
- Change in Systolic Blood Pressure(6 months)
- Change in Total Cholesterol(6 months)
- Change in Weight(6 months)