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

Not Applicable

Completed

Conditions: Type 2 Diabetes Mellitus

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

Registration Number: NCT04731142

Lead Sponsor: Imperial College London

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 235

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T2DEx remote care service	Video group consultations	-
T2DEx remote care service	KNOW Diabetes	-
T2DEx remote care service	Huma	-
Matched control group	Standard of care	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'.

Primary Outcome Measures

Name	Time	Method
Number of Deaths	12 weeks
Blood Pressure Measurements Recorded	12 weeks	Number of participants entering at least one blood pressure measurement
Number of Diabetes Distress Scale Scores Recorded	12 weeks	Number of participants entering at least one DDS measurement
Video Group Consultation Sessions Attended	12 weeks	the number of participants attending at least one VGC
Number of Weight Measurements Recorded	12 weeks	Number of participants entering at least one weight measurement
Blood Glucose Measurements Recorded	12 weeks	Number of participants entering at least one measurement
% Participants Downloading Huma App	12 weeks
Number of Participants With Hospital Admissions	12 weeks
Number of Participants With Emergency Department Admissions	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c	6 months	Change in HbA1c from beginning to end of programme
Change in Systolic Blood Pressure	6 months	Change in systolic BP from beginning to end of programme
Change in Total Cholesterol	6 months	Change in total cholesterol from beginning to end of programme
Change in Weight	6 months	Change in weight from beginning to end of programme

Trial Locations

Locations (7): North Connect Primary Care Network
🇬🇧
London, United Kingdom
Harrow Collaborative Primary Care Network
🇬🇧
London, United Kingdom
Sphere Primary Care Network
🇬🇧
London, United Kingdom
Hammersmith & Fulham Central Primary Care Network
🇬🇧
London, United Kingdom
Healthsense Primary Care Network
🇬🇧
London, United Kingdom
Metrocare & Celandine Health Primary Crae Network
🇬🇧
London, United Kingdom
Hammersmith & Fulham Partnership Primary Care Network
🇬🇧
London, United Kingdom