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

Study 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.

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

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Huma
* Behavioral: Video group consultations
* Behavioral: KNOW Diabetes
* Other: Standard of care


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An experimental feasibility study with a pre-test/post-test design using a matched control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T2DEx remote care service<br> | Device: Huma<br>* V. Digital remote patient monitoring using blood pressure and blood sugar devices in combination with a smartphone application ('the Huma app'). Participants are provided with home monitoring devices and download the Huma app. Participants are shown how to use the devices, how to input measurements into a smart phone and how to set personal goals. Data recorded via the Huma app is self-reported and includes activity data, diet information, blood glucose measurements, blood pressure measurements, weight, and the Diabetes Distress Scale (a self-reported questionnaire used to measure distress related to living with diabetes).<br>* Other names: Huma app;Behavioral: Video group consultations<br>* Each patient is invited to attend a total of three VGCs during the 12-weeks lasting approximately one hour and 15 minutes each. Each session is facilitated by a Practice Nurse (PN) and consists of 6-10 people with T2DM. The self-reported Huma app (see below) and patient EPR data are used to populate a Discussion Dashboard which is used in each VGC to facilitate discussion. During the first VGC session, patient goals are discussed and adjusted in a group setting with topics relevant to their condition covered by the PN. Between each VGC session, patients spend time working on their goals and continuing to enter self-reported metrics into the Huma app. During the second and third VGC sessions, each patient is discussed, along with their performance against agreed goals. The PN also uses pre-prepared content to discuss topics relevant to managing diabetes (e.g., staying motivated, low carb diets).<br>* Other names: VGC;Behavioral: KNOW Diabetes<br>* Each patient is signed up to a series of educational email campaigns to complement the VGC sessions and provide broader education around diabetes management. Patients receive two emails per week during the 12-week service on a variety of topics.<br>|
| Other: Matched control group<br>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'. | Other: Standard of care<br>* Normal primary care service provided to matched control group.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients offered the service vs. enrolled |  | 12 weeks | 
| % participants downloading Huma app |  | 12 weeks | 
| % participants collecting remote monitoring devices |  | 12 weeks | 
| Number of video group consultation sessions attended |  | 12 weeks | 
| Number of KNOW Diabetes emails opened |  | 12 weeks | 
| Number of blood glucose measurements recorded |  | 12 weeks | 
| Number of blood pressure measurements recorded |  | 12 weeks | 
| Number of weight measurements recorded |  | 12 weeks | 
| Number of Diabetes Distress Scale scores recorded |  | 12 weeks | 
| Number of primary care appointments |  | 12 weeks | 
| Cost per appointment |  | 12 weeks | 
| Cost of equipment per patient |  | 12 weeks | 
| Number of deaths |  | 12 weeks | 
| Number of emergency department admissions |  | 12 weeks | 
| Number of hospital admissions |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 6 months | 
| Lipids |  | 6 months | 
| Weight |  | 6 months | 
| Diabetes Distress Scale (DDS) Score |  | 6 months | 
| Blood glucose time-in-range |  | 6 months | 
| Systolic blood pressure |  | 6 months |