Type 2 Diabetes Exemplar: A Remote Care Service for North West London (T2DEx)

Imperial College London

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: Video group consultations; Other: Standard of care; Device: Huma; Behavioral: KNOW Diabetes

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04731142

20IC6484

Details and patient eligibility

About

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).

Full 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.

Enrollment: 235 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

  • 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

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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235 participants in 2 patient groups

T2DEx remote care service

Experimental group

Treatment:

Behavioral: KNOW Diabetes

Behavioral: Video group consultations

Device: Huma

Matched control group

Other group

Description:

This study will create a matched control group using propensity score matching (PSM), a quasi-experimental method used to mimic the characteristics of a randomised control trial that has been shown to reduce biases. PSM uses statistical techniques to construct an artificial control group by matching each study participant with a non-treated participant of similar characteristics. PSM computes the probability that a person would enrol in a program based on pre-defined characteristics, giving a 'propensity score'.

Treatment:

Other: Standard of care