Type 2 Diabetes Exemplar (T2DEx): A Remote Care Service for North West London
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Imperial College London
- Enrollment
- 235
- Locations
- 7
- Primary Endpoint
- Number of Deaths
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Number of Deaths
Time Frame: 12 weeks
Number of Participants With Emergency Department Admissions
Time Frame: 12 weeks
Blood Pressure Measurements Recorded
Time Frame: 12 weeks
Number of participants entering at least one blood pressure measurement
Number of Diabetes Distress Scale Scores Recorded
Time Frame: 12 weeks
Number of participants entering at least one DDS measurement
Video Group Consultation Sessions Attended
Time Frame: 12 weeks
the number of participants attending at least one VGC
Number of Weight Measurements Recorded
Time Frame: 12 weeks
Number of participants entering at least one weight measurement
Blood Glucose Measurements Recorded
Time Frame: 12 weeks
Number of participants entering at least one measurement
% Participants Downloading Huma App
Time Frame: 12 weeks
Number of Participants With Hospital Admissions
Time Frame: 12 weeks
Secondary Outcomes
- Change in HbA1c(6 months)
- Change in Systolic Blood Pressure(6 months)
- Change in Total Cholesterol(6 months)
- Change in Weight(6 months)