Clinical trial NCT04731142: Type 2 Diabetes Exemplar: A Remote Care Service for North West London
Official title: Type 2 Diabetes Exemplar (T2DEx): A Remote Care Service for North West London
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Huma
name: North West London Collaboration of CCGs (NWL CCGs)
name: Imperial College Health Partners (ICHP)
First posted: 2021-01-29
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An experimental feasibility study with a pre-test/post-test design using a matched control.
Primary purpose: TREATMENT

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.

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
  * 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).

Primary outcomes:
measure: % Participants Downloading Huma App
timeFrame: 12 weeks
measure: Video Group Consultation Sessions Attended
timeFrame: 12 weeks
measure: Blood Glucose Measurements Recorded
timeFrame: 12 weeks
measure: Blood Pressure Measurements Recorded
timeFrame: 12 weeks
measure: Number of Weight Measurements Recorded
timeFrame: 12 weeks
measure: Number of Diabetes Distress Scale Scores Recorded
timeFrame: 12 weeks
measure: Number of Deaths
timeFrame: 12 weeks
measure: Number of Participants With Emergency Department Admissions
timeFrame: 12 weeks
measure: Number of Participants With Hospital Admissions
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in HbA1c
timeFrame: 6 months
measure: Change in Total Cholesterol
timeFrame: 6 months
measure: Change in Weight
timeFrame: 6 months
measure: Change in Systolic Blood Pressure
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith & Fulham Central Primary Care Network
city: London
country: United Kingdom
facility: Hammersmith & Fulham Partnership Primary Care Network
city: London
country: United Kingdom
facility: Harrow Collaborative Primary Care Network
city: London
country: United Kingdom
facility: Healthsense Primary Care Network
city: London
country: United Kingdom
facility: Metrocare & Celandine Health Primary Crae Network
city: London
country: United Kingdom
facility: North Connect Primary Care Network
city: London
country: United Kingdom
facility: Sphere Primary Care Network
Study officials:
References: