Type 2 Diabetes Exemplar (T2DEx): A Remote Care Service for North West London
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Sponsor: Imperial College London

 
 
 
 
 
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Type 2 Diabetes Exemplar 
(T2DEx):  
A remote care service for North West 
London 
 
Study Management Group 
Co-Principal Investigators: Professor Kausik Ray; Gianluca Fontana 
 
Co-investigators: Dr Jack Halligan, Emanuela Falaschetti, Dr Victoria Cornelius 
 
This protocol describes the Type 2 Diabetes Exemplar (T2DEx): A remote care service 
for North West London study and provides information about procedures for entering 
participants. Every care was taken in its drafting, but corrections or amendments may 
be necessary. These will be circulated to investigators in the study. Problems relating 
to this study should be referred, in the first instance, to the research team’s project 
manager, Dr Jack Halligan.  
 
Sponsor 
 
Imperial College London is the main research Sponsor for this study. For further 
information regarding the sponsorship conditions, please contact the Head of 
Research Governance and Integrity. 
 
Funder 
 
Imperial College London (ICL) are funded through the Discover-NOW Health Data 
Research Hub, of which Imperial College Health Partners (ICHP) are lead partner and 
Imperial College London are an academic partner. Discover-NOW is funded by a grant 
from the UK Research and Innovation (UKRI) Industrial Strategy Challenge Fund 
(ISCF). Partial additional funding for the study (i.e., additional to the Hub grant funding) 
has been provided directly by ICHP. 
 

 
 
 
 
 
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The remote care service – ‘Fresh Start’ – being assessed by this research study has 
been designed and implemented as a collaboration between Discover-NOW partners, 
including ICL, ICHP, AstraZeneca, Huma and Collaboration Of North West London 
Clinical Commissioning Groups (NWL CCGs). 
 
Extraction, cleaning and de-identification of the study dataset will be completed by 
ICHP and is funded by AstraZeneca. Integration of data from Huma into NWL’s Whole 
of System Integrated Care (WSIC) database will be provided by InHealthcare as part 
of a pre-existing contract between the NWL CCGs Innovation Team and InHealthcare. 
 
AstraZeneca have funded the pathway service design within their in-kind contributions 
to Discover-NOW. Huma are funding the remote monitoring platform (patient app and 
clinician dashboard) for 12 months, the associated deployments to sites, and individual 
licenses within their in-kind contribution to Discover-NOW.  Discover-NOW are funding 
input from the NWL STP Diabetes Digital Transformation Lead (William Gilmour) and 
Clinical Director for Diabetes for NWL CCGs (Dr Tony Willis). 
 
NHSX are funding the remote care innovation implementation that underpins the study 
and the procurement of devices and consumables from Huma. NHSX will also fund a 
clinical implementation support role to help new sites implement Fresh Start, including 
the provision of training for participating staff. 
 
This study will adhere to the principles outlined in the UK Policy Framework for 
Health and Social Care Research It will be conducted in compliance with the 
protocol, Data Protection Act 2018 and General Data Protection Regulations 
(Europe) and other regulatory requirements as appropriate.  
 

 
 
 
 
 
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TABLE OF CONTENTS 
Contents 
1. INTRODUCTION 
4 
1.1 
Background 
4 
1.2 
Study Rationale 
4 
2. STUDY AIMS AND OBJECTIVES 
5 
3. STUDY DESIGN AND METHODS 
6 
3.1 Design 
6 
3.2 Study population 
6 
3.3 Sample size 
6 
3.4 The Fresh Start service 
7 
3.5 Matched control group 
8 
3.6 Outcome measures 
10 
3.7 Study procedures 
12 
3.8 Training 
16 
3.9 Follow-up 
17 
3.10 Study timeline 
17 
3.11 Data analysis 
18 
3.12 Data privacy and security 
18 
4. RECRUITMENT 
19 
4.1 Recruitment to Fresh Start 
19 
4.2 Recruitment for interviews – people with type 2 diabetes (x10) and HCPs (x10) 
20 
4.3 Inclusion criteria 
20 
4.4 Exclusion criteria 
21 
4.5 Withdrawal criteria 
21 
5. ADVERSE EVENTS 
21 
5.1 Definitions 
21 
5.2 Reporting procedures 
22 
6. REGULATORY ISSUES 
23 
6.1 
Ethics approval 
23 
6.2 
Consent 
23 
6.3 
Confidentiality 
23 
6.4 
Indemnity 
23 
6.5 
Sponsor 
23 
6.6 
Funding 
23 
6.7 
Audits 
24 
7. PUBLICATION POLICY 
24 
APPENDIX 1: FRESH START OVERVIEW 
25 
APPENDIX 2: OVERVIEW OF STUDY PROCEDURES 
26 
APPENDIX 3: EXAMPLE VGC DISCUSSION BOARD 
27 
APPENDIX 4: REFERENCES 
28 
 

 
 
 
 
 
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1. Introduction 
 
1.1 
Background 
Type 2 diabetes is a cardiometabolic disorder with associated vascular disease associated 
with half a decade of life years lost1 or a decade and half among those with atherosclerotic 
cardiovascular disease (ASCVD).2 Despite significant improvements in outcomes, mortality 
and morbidity remains higher among those with type 2 diabetes vs those without. A global 
approach starting with lifestyle and pharmacotherapy to address multiple risk factors is 
required to reduce the burden of disease. Observational data supports the notion that control 
of multiple risk factors attenuates the residual risk especially among younger subjects.3 4  
 
Broadly, complications of type 2 diabetes can be broken down into those that affect the 
macrovascular system (myocardial infarction, stroke, peripheral arterial disease) and those 
that effect the microvascular system (chronic kidney disease, retinopathy, neuropathy). The 
former requires control of multiple factors that affect cardiovascular disease such as lipid 
lowering, blood pressure control, and smoking cessation (among others). The latter is more 
closely related to long-term glycaemic control in particular, but potentially other factors such 
as BP control and use of specific therapies aimed at end organ preservation (e.g., RAS 
blockade, SGLT2 inhibitors). 
 
Practice nurses (PNs) in primary care spend significant time in consultations with patients 
about managing their type 2 diabetes. Group consultations have been identified as an 
opportunity to improve outcomes and access, whilst engaging patients in a different way that 
offers the potential to provide a more social and less medical model of planned care.5 
Experience in other parts of England suggested that it could also improve staff experience 
by reducing repetition and creating more time to care and support patients.5 Group 
consultations also have a strong evidence base of impact in type 2 diabetes, with seven 
randomised controlled trials showing improvements in HbA1c compared to one-to-one care.6 
1.2 
Study Rationale 
As the prevalence of Type 2 Diabetes Mellitus (T2DM) grows the burden on healthcare is 
increasing in the form of additional consultations, hospital outpatient visits, death and 
disability. T2DM represents a large part of the disease and cost burden of healthcare in North 
West London (NWL) to the value of £600m annually. Patients with T2DM constitute over 40% 
of all NWL admissions, with complications of type 2 diabetes representing a significant factor 
in the morbidity and cost associated with this chronic disease. To this end, there is an urgent 
need for healthcare professionals to provide the same or better care without increasing 
healthcare expenditure. Digital interventions/ healthcare solutions may provide an opportunity 
to achieve these goals.  

 
 
 
 
 
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The Type 2 Diabetes Exemplar Programme has designed the Fresh Start service for use in 
primary care to demonstrate how real-world data and technology can improve health 
outcomes for T2DM patients. Fresh Start has been designed by the Discover-NOW Health 
Data Research Hub in a cross-industry collaboration between North West London CCGs, 
NHSX, AstraZeneca, Imperial College Health Partners and Huma. Fresh Start is offered to 
patients at high risk of developing complications from T2DM and combines video group 
consultations, a remote monitoring solution, and educational content. 
 
Fresh Start seeks to support population stratification and 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 and provide remote care pathways to patients. Digital-first 
remote pathways could make care more accessible while finding time and cost efficiencies. 
By combining remote monitoring and video group consultations, we can inform the patient-
clinician conversation making remote care in group settings safer, efficient and more 
personalised. 
 
It is our opinion that generating credible evidence for digital health solutions remains an 
industry-wide challenge, hindering widespread adoption, and that traditional approaches 
present limitations for researchers to create evidence. Evaluation of digital health solutions 
has also been identified as requiring improvement and has been cited as a major obstacle for 
wider adoption.7 8 This study will use pragmatic methods to evaluate Fresh Start, with a view 
to support successful adoption of Fresh Start in primary care practices in the UK.  
 
2. Study aims and objectives 
The aim of T2DEx is to assess the feasibility, usability, acceptability, cost-effectiveness and 
safety of a remote care service (“Fresh Start”) in primary care for people with ‘high risk’ or 
‘very high risk’ Type 2 Diabetes in North West London.  
 
The study will assess patient and clinician experience metrics, the feasibility of 
implementation including uptake and patient/physician acceptability for data collection 
procedures, and the resources needed to manage and implement Fresh Start . The study 
will also assess the impact of Fresh Start on clinical outcome measures (e.g., HbA1c, risk 
factor control, time at goal). 
 
The results of this may support continuation of Fresh Start. A follow-up study with a larger 
number of participants and longer duration would be required to assess a statistically 
significant impact on secondary objectives. 
 

 
 
 
 
 
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Primary objectives: 
1. To assess the feasibility of uptake amongst people with ‘high risk’ or ‘very high risk’ 
type 2 diabetes. 
2. To assess the usability of Fresh Start amongst people with ‘high risk’ or ‘very 
high risk’ type 2 diabetes. 
3. To assess the usability of Fresh Start amongst HCPs. 
4. To assess the acceptability of Fresh Start amongst people with ‘high risk’ or ‘very 
high risk’ type 2 diabetes. 
5. To assess the acceptability of Fresh Start amongst HCPs. 
6. To assess the cost-effectiveness of delivering Fresh Start. 
 
Secondary objectives (EXPLORATORY only and will not be demonstrated to a level of 
statistical significance): 
 
1. To assess the safety of Fresh Start. 
2. To assess the impact of Fresh Start on clinical outcomes. 
 
3. Study design and methods 
3.1 Design 
An experimental feasibility study with a pre-test/post-test design using a matched control.  
3.2 Study population 
In response to the public health emergency posed by COVID-19, NHS England and NHS 
Improvement (London) are supporting clinicians to identify patients who are at the higher risk 
of adverse outcomes (based on available evidence) and prioritise the allocation of existing 
resources to these patients. 
 
The study population therefore includes people with ‘high risk’ and ‘very high risk’ type 2 
diabetes (see ‘Inclusion criteria’), as defined by guidance for primary care from NHS England 
and NHS Improvement (London), entitled Primary Care: Identification, risk stratification and 
interventions for patients at an increased risk.  
3.3 Sample size 
The study will seek to collect and analyse data from a minimum of 300 participants to Fresh 
Start. With an estimated enrolment rate of 20%, 1,500 eligible patients will need to be 
identified and we will be able to estimate this rate within a 95% confidence interval of +/-3%, 
accounting for variance inflation due to clustering with the assumption of 10 GP practices 
and Intraclass Correlation Coefficient (ICC) of 0.05.  
 
The study’s secondary objectives are exploratory only and will not be demonstrated to a 
level of statistical significance in this study.  
 

 
 
 
 
 
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3.4 The Fresh Start service 
This 12-week service has been designed to optimise patient care based on pro-active 
identification and prioritisation of clinical risk based on health, socioeconomic and 
demographic factors. ` 
 
Fresh Start seeks to assess whether alternative methods of healthcare delivery for 
people with high-risk or very high risk T2DM are safe, scalable, and cost-effective. 
Fresh Start has been co-designed with people with type 2 diabetes, healthcare professionals 
(GPs, specialists, nurses, podiatrists, dietitians) and commissioners from Collaboration Of 
North West London Clinical Commissioning Groups (NWL CCGs).  
 
The North West London Diabetes Clinical Reference Group (CRG) reviewed and 
provided feedback on Fresh Start’s design. The CRG comprised of three GPs, three 
endocrinologists, three vascular surgeons, two specialist podiatrists, two diabetes nurse 
specialists, one district nursing lead, one infection control lead, two commissioners/quality 
improvement leads and one psychiatrist. 
 
Fresh Start will support delivery of the new Integrated Care System (ICS) and Primary 
Care Network (PCN) models currently being rolled-out across the NHS. 
The Fresh Start service and SOPs have been specifically designed to enable a new model 
of care as part of the NHS Long Term Plan.  
 
Individual primary care practices play a central role in service delivery. GPs, nursing 
staff and administrative staff from primary care practices have advised how best to adopt 
Fresh Start into the primary care clinical workflow and have helped to develop standard 
operating procedure (SOP) documentation to support participating practices. 
 
 
The 12-week service comprises the following elements (overview provided at Appendix 1): 
 
I. 
Proactive risk stratification. An electronic patient record (EPR) based risk 
stratification search is run at primary care practice level to identify T2DM patients at 
high risk of cardiovascular complications who may benefit from and be eligible for 
Fresh Start. 
II. 
Video Group Consultations (VGC). 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 
type 2 diabetes (e.g., staying motivated, low carb diets). 
III. 
Fresh Start educational email campaigns. Each patient is signed up to a series of 
educational email campaigns to complement the VGC sessions and provide broader 

 
 
 
 
 
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education around type 2 diabetes management. Patients receive two emails per 
week during the 12-week service on a variety of topics. 
IV. 
Clinical protocols. A series of best-practice CRG approved clinical protocols are in 
place to be triggered based on thresholds and values captured via the Huma app and 
as part of the VGC sessions. Protocol examples include medications review, foot 
care, renal, and mental health. 
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). A Health Care 
Assistant (HCA) observes these data via a Huma clinician dashboard that 
complements the Huma app. The HCA presents these data in combination with 
relevant EPR data to the PN for review ahead of each VGC appointment. 
VI. 
One-to-one routine patient review. At the end of the 12-weeks participants are 
invited to a one-to-one review session with their primary care practice. The patient’s 
progress over the 12-week service is reviewed and a decision is made whether to 
discharge patient, repeat them for another 12 weeks on Fresh Start, or escalate them 
to MDT. 
3.5 Matched control group 
A number of the study’s objectives and associated outcome measures will require a control 
group for comparison. These objectives include: 
 
▪ 
To assess the cost-effectiveness of delivering Fresh Start; 
▪ 
To assess the safety of Fresh Start; and 
▪ 
To assess the impact of Fresh Start on clinical outcomes. 
 
This study will create a matched control group using propensity score matching (PSM),9 a 
quasi-experimental method used to mimic the characteristics of a randomised control trial 
that has been shown to reduce biases.10 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’. 
 
The propensity score for the study will be based on the following characteristics: 
▪ 
Age 
▪ 
Gender  
▪ 
Risk category (see inclusion criteria) 
▪ 
Geographical proximity  
▪ 
Social deprivation index (by practice) 
 
Each individual in the matched control group will be identified within one month of the index 
case. 
 

 
 
 
 
 
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The matched control group will be identified using NWL’s Whole of Systems Integrated Care 
(WSIC) database. WSIC links provider data from four acute, two mental health and two 
community Trusts across eight CCGs, social care data from eight boroughs and 380 GP 
practices to generate an integrated care record.

 
 
 
 
 
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3.6 Outcome measures 
Primary objective 
Outcome measure 
Where is it 
recorded? 
How often is it measured? 
Compare 
with 
control? 
To assess the feasibility of uptake 
amongst people with ‘high risk’ or 
‘very high risk’ type 2 diabetes. 
Patients offered Fresh Start vs. enrolled 
EPR 
Once 
No 
Patients enrolled vs. collecting remote monitoring devices 
EPR 
Once  
No 
Patients enrolled vs. downloading Huma app 
Huma 
Once  
No 
To assess the usability of Fresh 
Start amongst people with ‘high risk’ 
or ‘very high risk’ type 2 diabetes. 
Number of VGCs attended 
EPR 
Every 4 weeks 
No 
Number of Fresh Start emails opened 
KD 
Twice weekly 
No 
Number of blood glucose measurements recorded  
Huma 
Daily 
No 
Number of blood pressure measurements recorded 
Huma 
Daily 
No 
Number of weight measurements recorded 
Huma 
Monthly 
No 
Number of Diabetes Distress Scale measurements recorded 
Huma 
Monthly 
No 
To assess the usability of Fresh 
Start amongst HCPs. 
System Usability Scale (SUS11) questionnaire 
Online 
survey 
Once (at 12 weeks) 
No 
To assess the acceptability of 
Fresh Start amongst people with 
‘high risk’ or ‘very high risk’ type 2 
diabetes. 
Interviews with patients (x10) 
Interview 
At 12 weeks 
No 

 
 
 
 
 
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To assess the acceptability of 
Fresh Start amongst HCPs. 
Interviews with healthcare professionals (HCPs, x10) 
Interview 
After intervention period 
No 
To assess the cost-effectiveness of 
delivering Fresh Start. 
Number of primary care appointments per patient  
EPR 
Data extracted from EPR 
Yes 
Cost per appointment per patient  
EPR 
Data extracted from EPR 
Yes 
Cost of equipment per patient 
Huma 
N/A 
No 
Secondary objective (Exploratory)* 
Outcome measure 
 
 
 
To assess the safety of Fresh Start. 
Number of deaths 
EPR 
Data extracted from EPR 
Yes 
Number of emergency department admissions 
WSIC 
Data extracted from WSIC 
Yes 
Number of hospital admissions 
WSIC 
Data extracted from WSIC 
Yes 
To assess the impact of Fresh Start on 
clinical outcomes. 
HbA1c 
EPR 
Baseline, 12 weeks, 6 months 
Yes 
Lipids, incl. LDL and non-HDL cholesterol 
EPR 
Baseline, 12 weeks, 6 months 
Yes 
Weight 
EPR 
Baseline, 12 weeks, 6 months 
Yes 
Diabetes Distress Scale score (DDS12) 
Huma 
Monthly during service (and 
at 6 month follow-up appt.) 
No 
Blood glucose time-in-range  
Huma 
Daily 
Yes 
Systolic blood pressure (SBP) 
Huma 
Daily 
Yes 
*Note: Secondary objectives are exploratory only and will not be demonstrated to a level of statistical significance.

 
 
 
 
 
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3.7 Study procedures 
This section provides detail on the procedures for delivering Fresh Start and data collection. 
Standard operating procedure (SOP) documents that go into greater detail have been 
developed for staff at primary care practices who will be delivering Fresh Start. These 
include SOPs for practice nurses (PNs), healthcare assistants (HCAs), and administrative 
staff. A training document has also been developed for participating primary care practices.  
 
The below are the main steps involved to deliver Fresh Start. A high-level overview of study 
procedures is also provided at Appendix 2. 
▪ 
Patient search 
▪ 
Outreach, qualification and booking 
▪ 
Onboarding 
▪ 
Fresh Start educational emails 
▪ 
Huma app, devices and clinician dashboard 
▪ 
Video group consultations (VGCs) 
▪ 
Discharge, repeat, or MDT escalation 
▪ 
Interviews with patients and healthcare professionals 
▪ 
Online System Usability Scale (SUS) survey 
 
Patient search 
EPR searches have been constructed based on the inclusion criteria for this study (see 
Section 4.3). This search will be run by administrative staff at participating primary care 
practices. Patients will then be invited to participate in the program. 
 
Staff actions at primary care practice: 
▪ 
Open practice management system and run report search 
▪ 
Sense-check list of patients against risk stratification criteria 
▪ 
Mark exported patients to receive outreach invitation to service 
 
Outreach, qualification and booking 
Outreach will involve a 10-minute initial conversation with patients identified in the search to 
speak to them about how Fresh Start may help them, find out if they are able to participate, 
and, if interested, book them onto the required appointments to start on Fresh Start. The 
participant must be able to download the Huma App to their smartphone or tablet. 
 
Staff actions at primary care practice: 
▪ 
Phone patients on the outreach list  
▪ 
Qualify if patients are eligible for service  
▪ 
Organise device collection from the practice 
▪ 
Book patient onto onboarding appointment 
▪ 
Keep track of the uptake of Fresh Start 
▪ 
Book patient for baseline measurements, which will include: 
o HbA1c 
o Lipid panel 
o Weight 
 
Onboarding  

 
 
 
 
 
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A 30-45 minute onboarding appointment will be completed by a practice nurse (PN), 
healthcare assistant (HCA) or a member of the administrative staff from the participant’s 
primary care practice (at the discretion of the participating practice). The onboarding 
appointment can be completed via Microsoft Teams or face-to-face (at the discretion of the 
participant/primary care practice). The onboarding appointment will be used to explain the 
Huma app, video group consultations (VGCs), and the educational emails from Fresh Start. 
An onboarding guide and associated script has been developed to support the onboarding 
process. 
 
Staff actions at primary care practice: 
▪ 
Run one-to-one appointment via Microsoft Teams or a phone call  
▪ 
Explain how to download and use Huma app & devices 
▪ 
Book onto VGCs (x3) 
▪ 
Sign up for Fresh Start emails 
 
Fresh Start educational emails  
Patients will be instructed to sign up for Fresh Start educational emails during the 
onboarding appointment. These emails will be twice-weekly and will ensure patients get 
supportive information and education on how to improve their type 2 diabetes. 
 
Staff actions at primary care practice: 
▪ 
Sign patients up to first two Fresh Start emails in onboarding call  
▪ 
Sign patients up to full Fresh Start campaign in first VGC 
 
  
 
Huma app, devices and Clinician Dashboard  
The Huma app will enable particiapnts to report their own clinical metrics, feelings, goals and 
behaviour activities (e.g. photos of food). At the onboarding appointment, participants will be 
instructed how to download the Huma app from the App Store (for iPhone users) or from the 
Google Play Store (for all other smartphones). Participants will also be shown how to use 
their blood pressure cuff and glucometer device, walked through the Diabetes Distress Scale 
questionnaire, and shown how to set goals and actions in the Huma app.  
 

 
 
 
 
 
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Participants will be asked to enter results from their first measurements into the Huma app. 
The HCP who is running the onboarding appointment will check whether results have 
appeared on the Huma clinician dashboard. If data has not appeared HCPs are advised to 
contact Huma at support@huma.com. 
 
Huma will also provide a “Clinician Dashboard” to review patient reported data to inform care 
decisions. The Huma Clinician Dashboard will be used to monitor the blood pressure and 
blood glucose measurements of participants as they are entered into the Huma app. A HCA 
at each practice will review the Huma clinician dashboard and escalate any urgent readings 
to the GP. Data from the dashboard will be provided to PNs in advance of VGCs and will be 
used to trigger non-urgent care protocols before and after VGC sessions. 
 
Staff actions at primary care practice: 
▪ 
Review Huma Clinician Dashboard daily  
▪ 
Escalate to GPs when there has been an urgent reading 
 
 
 
Video group consultations (VGCs) 
VGCs will be booked and the process for VGCs explained during onboarding. Participants 
will be booked onto their first VGC approximately one week from the date of the onboarding 
session, with the second and third booked at four week intervals. Reminder emails 
containing the Microsoft Teams link to join the session will also be set up during this session. 
Each VGC will last for 1 hour and 15 minutes in total. 
 
Staff actions at primary care practice before each VGC: 
▪ 
Open Huma Clinician Dashboard patient template side-by-side and manually port 
patient-reported data from the Huma app into the EPR as follows for patients due to 
attend VGC session 
o 1 x latest blood pressure reading 
o 1 x latest blood glucose 
Patient iPhone and Android app
Clinician Dashboard
Patient Remote Monitoring Devices
• Blood pressure cuff
• Blood glucometer, strips and lances
• Digital scales

 
 
 
 
 
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o 1 x latest Diabetes Distress Score  
o 1 x latest weight (BMI automatically calculated) 
o Average daily step count for the last week (total for the week / 7) 
▪ 
Open VGC Discussion Board slide and populate using EPR data 
o Blood pressure – latest reading 
o Blood glucose – latest reading 
o DDS – latest reading 
o BMI – latest reading 
o Average daily step count for the last week (total for the week / 7) 
▪ 
Review food pictures in Huma dashboard 
o Decide whether to discuss food pictures for that patient on VGC session 
 
Staff actions at primary care practice during each VGC: 
▪ 
Set-up Teams meeting and troubleshoot potential problems with participants (15mins 
before session start time)  
▪ 
Take consent  
▪ 
Share link for Fresh Start emails 
▪ 
Introductions and theme (video played – 10/15 slides talked to) 
▪ 
Answer questions in the chat 
▪ 
Review VGC Discussion Board (see Appendix 3 for example) 
o Speak with each patient one-by-one 
o Set actions for each person 
 
Staff actions at primary care practice after each VGC: 
▪ 
Review VGC Discussion Board and notes from VGC session 
▪ 
Discuss each patient and possible clinical protocols to apply (e.g. medication, 
footcare, mental health, renal etc.) 
▪ 
Make changes to care plan in practice management system 
▪ 
Refer or book one-to-one appointments with patients (as required) 
 
 
 
 
Discharge, Repeat or MDT Escalation 
At 12 weeks each participant will be formally reviewed and decisions can be made for their 
future care-plan. 
3 x 1h15m sessions
Huma app data is used to inform and 
structure conversations with patients
•
6-10 patients
•
1 facilitator
•
1 clinician

 
 
 
 
 
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Staff actions at primary care practice: 
▪ 
Review patient’s progress 
▪ 
Decide whether to discharge patient, repeat them for another 12 weeks on Fresh 
Start, or escalate them to MDT 
▪ 
Complete 12-week measurements, including: 
o HbA1c 
o Lipid panel 
o Weight 
 
Interviews with patients and HCPs. 
After the intervention period, interviews will be conducted with 10 people with type 2 
diabetes who have participated in Fresh Start and with 10 healthcare professionals from 
participating primary care practices who have delivered Fresh Start. 
 
Online System Usability Scale (SUS) survey 
After the intervention period, the SUS will be distributed via email to all healthcare 
professionals at participating primary care practices. The SUS is a reliable tool for measuring 
the usability of a system or service. It consists of a 10-item questionnaire with five response 
options via a Likert scale, ranging from ‘Strongly agree’ to ‘Strongly disagree’. 
3.8 Training 
The aim of the T2DEx training is to equip clinicians and practice staff with sufficient 
understanding of Fresh Start’s objectives and operations to deliver it autonomously at their 
respective sites. The training will be divided into three sessions lasting approximately 1.5 
hours each. These sessions will be led by a member of the ICHP team or a clinical 
implementation role funded through NHSX. 
 
Training sessions will be run via Microsoft Teams using training slide decks that has been 
created by ICHP. The slide decks form part of the virtual resource pack hosted in Teams, 
which includes all materials required for Fresh Start delivery. The trainer will walk the 
attendees through the slide deck, allowing time for questions during the session and at the 
end. Attendees will receive a feedback form at the end of each session to record their 
feedback on the training. After each session the trainer will share a copy of the deck with all 
attendees and invite the attendees to send any questions.  
 
▪ 
The first session will provide an introduction to the Fresh Start objectives and an 
overview of all the Fresh Start components. Staff tasked with delivering Fresh Start 
should attend the full session. This will likely include PNs (practice nurses), 
healthcare assistants (HCAs), and administrative staff. General practitioners (GPs) or 
advanced nurse practitioners (ANPs) involved with running the VGCs should also 
attend the full session. It is recommended that other staff attend the first 15 minutes 
of this session if they will assume responsibility for any Fresh Start components when 
their colleagues are absent or on annual leave. At the end of the first session, 
attendees will be shown the virtual resource pack in Teams. The aim is to show the 
attendees a summary of the resource pack materials and the location of the materials 
they will require for their role in Fresh Start. All attendees should be given access to 

 
 
 
 
 
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the resource pack to review and the opportunity to contact the training team with 
questions. 
 
▪ 
The second session will cover the search, outreach, qualification and booking, 
onboarding and Huma Clinician Dashboard monitoring components of Fresh Start . 
Staff responsible for these components should attend the full session. This will likely 
include HCAs and administrative staff. A representative from the Huma Customer 
Success team will join the session to demonstrate the Huma sign-up process and 
answer questions on the application and dashboard functionality. At the end of the 
second session attendees will be shown the resource pack folders relevant to the 
Fresh Start components covered in the session. All attendees should be given 
access to the demo versions of the Huma App and the Huma Clinician Dashboard to 
test in their own time. Attendees may have questions about the app and dashboard, 
which might require an additional session with Huma. It is recommended that short 
role-play sessions on onboarding and Clinician Dashboard monitoring are held 
before Fresh Start is formally launched.   
 
▪ 
The third session will cover the VGC elements of Fresh Start; before, during and 
after. Staff responsible for these components should attend the full session. This will 
likely include HCAs, administrative staff, PNs, GPs or ANPs. A clinician familiar with 
the VGC content can join the session to deliver the ‘during’ section. At the end of the 
second session attendees will be shown the resource pack folders relevant to the 
Fresh Start components covered in the session. It is recommended that staff involved 
with delivering VGC session run a practice session to test Microsoft Teams and the 
content and structure of the session. 
3.9 Follow-up 
Patient’s will be assessed at follow-up appointment with their primary care practice at month 
6 (i.e., 3 months after completing the programme). Outcome measures recorded at this 
appointment will include: 
▪ 
HbA1c 
▪ 
Blood pressure 
▪ 
Blood glucose 
▪ 
Lipids  
▪ 
Diabetes Distress Scale (DDS) 
 
3.10 Study timeline 
The below table gives a high-level overview of the study timeline. 
 
Month 
1 
2 
3 
4 
5 
6 
7 
8 
9 
Recruit GP practices and train clinicians   
  
  
  
  
  
  
  
  
Recruit participants 
  
  
  
  
  
  
  
  
  
Deliver the intervention 
  
  
  
  
  
  
  
  
  

 
 
 
 
 
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Follow-up period 
 
 
 
 
 
 
 
 
 
Interviews with patients and HCPs 
  
  
  
  
  
  
  
  
  
Analysis and write-up 
 
 
 
 
 
 
 
 
 
 
3.11 Data analysis 
The research team will not have access to any personal or identifiable patient data as part of 
the project. Data will be de-identified before being transferred to WSIC’s de-identified data 
(DID) environment and made available to approved researchers. Any data extracted from 
the secure environment after analysis by the research team will be at an aggregate level 
only. 
 
All outcomes will be reported using descriptive statistics with tables and graphical 
presentations of findings. Continuous variables will be presented as means and standard 
deviations if normally distributed, and as medians and inter-quartile ranges for skewed data, 
whilst categorical variables will be presented as frequencies and percentages. 
 
To assess the pre-test/post-test change on clinical outcomes the appropriate generalized 
mixed model approach will be used to account for repeated measurements and clustering of 
GP practices and including important covariates in the model. 
 
To create a matched control group from NWL’s WSIC database, a 1:1 propensity score 
matching (PSM) analysis will be performed using age, gender, risk category, geographical 
proximity and social deprivation index as matching variables. R statistical software will be used 
for estimating PS by logistic regression and for balance and sensitivity checks. 
 
Comparisons with the control group for clinical outcomes will be exploratory and differences 
with 95% CI will be reported using the appropriate generalized mixed model. 
 
Interviews conducted with participants and healthcare professionals will be analysed using 
NVivo, where responses will undergo thematic analysis using an inductive approach to derive 
key themes. 
3.12 Data privacy and security 
 
The research team will not have access to any personal or identifiable patient data as part of 
the project. Data will be de-identified before being transferred to WSIC’s de-identified data 
(DID) environment and made available to approved researchers. Any data extracted from 
the secure environment after analysis by the research team will be at an aggregate level 
only. 
 
A single WSIC analyst who is responsible for flagging patients in the matched control group 
will have access to the personal identifiable data (PID) environment. This WSIC analyst has 

 
 
 
 
 
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a substantive contract with the data controller and is authorised to execute the flagging in the 
PID. 
 
The WSIC dataset is a PID hosted by UKCloud in a secure cloud-based environment, which 
is ISO27017 certified. This is an Identifiable data set which supports clinicians and health 
care professionals to provide joined-up care, decision-support and workflow automation. 
This information feeds into a wide range of bespoke assets for example clinical facing WSIC 
dashboards and the Health Information Exchange (HIE) for use by clinicians, and the Care 
Information Exchange (CIE) and coordinate my care for use by citizens. 
  
Discover Dataset is de-identified dataset hosted in a secure Azure environment and to be 
hosted by IBM in a new Trusted Research Environment (TRE). This depersonalised data set 
is for quality improvement planning and research, it is controlled by NWL data controllers, 
and access to it is mediated by the NWL Data Access Committee. It is accessible via 
Discover-NOW Health Data Research Hub for Real World Evidence through their data 
scientists specialists hosted by Imperial College Health Partners (ICHP) and IG committee-
approved analysts to conduct research within the safe environment. 
 
Data collected on the Huma platform is hosted in the UK by Google Cloud Platform (GCP) 
who manage all physical servers, resources and networking hardware to enable all business 
logic and higher-level services. All communications are secured by TLS. Huma follows NIST 
approved encryption techniques for encrypting data-at-rest. Huma's cloud provider provides 
Key Management Services (KMS) for data storage services using an encryption key. Key 
rotation is performed. Huma practises the concept of least-privileged permissions for 
services. Huma also conforms to the following accreditations and standards: 
• 
NHS Data Security and Protection Toolkit certification (organisational code: YGMA8) 
• 
ISO13485 Certified Quality Management System with robust Risk Management Plan 
that includes Data Security & Protection, Business Continuity, Disaster Recovery, & 
implementation of Corrective & Preventive Actions 
 
4. Recruitment 
4.1 Recruitment to Fresh Start 
Participants will include patients from participating primary care practices in NWL with ‘high 
risk’ and ‘very high risk’ of developing complications from T2DM. Risk stratification has been 
defined by guidance for primary care from NHS England and NHS Improvement (London) 
entitled Primary Care: Identification, risk stratification and interventions for patients at an 
increased risk. EPR searches have been constructed based on this risk stratification. 
Selected patients will then be invited to participate in the program, with those who accept 
being onboarded (see Section 3.7 for more detail). 

 
 
 
 
 
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4.2 Recruitment for interviews – people with type 2 diabetes (x10) 
and HCPs (x10) 
A total of 10 people with type 2 diabetes and 10 HCPs will be recruited to participate in 
interviews to assess the acceptability of Fresh Start to HCPs. Potential interviewees will 
be sent an email invitation to take. Those that express an interest in taking part will be 
emailed a participant information sheet and consent form by a member of the research team. 
Interviews will be carried out via Microsoft Teams and the duration of each interview will be 
approximately 45 minutes. 
 
Participants will have a choice on the consent form to allow the researchers to audio-
record the interview for the sole purpose of analysing the transcript in NVivo. All recordings 
will be deleted once transcription has been completed using a service such as PageSix. 
Alternatively, participants who do not wish to be audio recorded can still take part, the 
researcher will be responsible for capturing written notes during the session. 
 
Participants in the interviews to assess Fresh Start’s acceptability will be 
remunerated. Public participants (i.e., people with type 2 diabetes) will be paid £30 per hour 
for this online engagement (£25 per hour for their involvement plus an additional £5 to cover 
for WiFi/electricity). This is as per latest INVOLVE guidelines on patient and public 
involvement in research activity. All clinicians will be paid £100 per hour for their 
involvement. 
 
4.3 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: 
o HbA1c >58 mmol/mol 
o SBP >140 mm Hg 
o Non-HDL >3.35 mmol/L or LDL-C >2.5 mmol/L 
o Nephropathy (eGFR <45 ml/min, or Urine ACR >3 mg/mol) 
o Retinopathy 
o Neuropathy (including moderate/high risk feet, previous foot ulceration and 
erectile dysfunction) 
o Currently smoking 
▪ 
High risk - T2DM without ASCVD but with any 2 of the following: 
o HbA1c > 58 mmol/mol 
o SBP >140 mm Hg 
o Non-HDL >3.35 mmol/L or LDL-C >2.5 mmol/L 
o Nephropathy: eGFR <45 ml/min or Urine ACR >3 mg/mol 
o Retinopathy 

 
 
 
 
 
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o Neuropathy (including moderate/high risk feet, previous foot ulceration and 
erectile dysfunction) 
o Currently smoking 
o Black, Asian and minority ethic (BAME) status  
4.4 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). 
4.5 Withdrawal criteria  
Subjects may be withdrawn from the study at the discretion of the investigator team due to a 
safety concern or if judged non-compliant with trial procedures. Reasons for withdrawals and 
discontinuation of any subject from the protocol will be recorded by the investigator team. 
 
A subject must be withdrawn from treatment if one of the following applies: 
 
▪ 
Subject chooses to withdraw from the study (at any time) 
▪ 
Major violation of the study protocol 
▪ 
Other circumstances that would endanger the health of the subject if he/she were to 
continue his/her participation in the trial 
 
5. Adverse events 
5.1 Definitions 
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study subject.   
 
Serious Adverse Event (SAE): any untoward and unexpected medical occurrence or effect that: 
• 
Results in death 

 
 
 
 
 
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• 
Is life-threatening – refers to an event in which the subject was at risk of death at the 
time of the event; it does not refer to an event which hypothetically might have caused 
death if it were more severe 
 
• 
Requires hospitalisation, or prolongation of existing inpatients’ hospitalisation 
• 
Results in persistent or significant disability or incapacity 
• 
Is a congenital anomaly or birth defect 
 
Medical judgement should be exercised in deciding whether an AE is serious in other situations.  
Important AEs that are not immediately life-threatening or do not result in death or hospitalisation 
but may jeopardise the subject or may require intervention to prevent one of the other outcomes 
listed in the definition above, should also be considered serious. 
5.2 Reporting procedures 
All adverse events should be reported. Depending on the nature of the event the reporting procedures 
below should be followed.  Any questions concerning adverse event reporting should be directed to 
the Chief Investigator in the first instance.   
 
5.2.1 Non serious AEs 
All such events, whether expected or not, should be recorded- it should be specified if only some non-
serious AEs will be recorded, any reporting should be consistent with the purpose of trial end points.  
 
5.2.2 Serious AEs 
An SAE form should be completed and emailed to the Chief Investigator within 24 hours.  However, 
hospitalisations for elective treatment of a pre-existing condition do not need reporting as SAEs. 
 
All SAEs should be reported to the Bromley Research Ethics Committee (bromley.rec@hra.nhs.uk) 
where in the opinion of the Chief Investigator, the event was: 
• 
‘related’, ie resulted from the administration of any of the research procedures; and 
• 
‘unexpected’, i.e., an event that is not listed in the protocol as an expected occurrence 
 
Reports of related and unexpected SAEs should be submitted within 15 days of the Chief Investigator 
becoming aware of the event, using the NRES SAE form for non-IMP studies.  The Chief Investigator 
must also notify the Sponsor of all SAEs. 
 
Local investigators should report any SAEs as required by their Local Research Ethics Committee, 
Sponsor and/or Research & Development Office. 
 
Contact details for reporting SAEs 
RGIT@imperial.ac.uk 
CI email (and contact details below) 
Please send SAE forms to: k.ray@imperial.ac.uk and Cc j.halligan@imperial.ac.uk 
Tel: +447742161980 (Mon to Fri 09.00 – 17.00) 

 
 
 
 
 
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6. Regulatory issues 
6.1 
Ethics approval 
The Principal Investigator has obtained approval from the Health Research Authority via the 
Bromley Research Ethics Committee. The study will be conducted in accordance with the 
recommendations for physicians involved in research on human subjects adopted by the 18th 
World Medical Assembly, Helsinki 1964 and later revisions. 
 
6.2 
Consent  
Consent to enter the study will be sought from each participant only after a full explanation 
has been given, a patient information sheet offered, and time allowed for consideration. Signed 
participant consent will be obtained. The right of the participant to refuse to participate without 
giving reasons will be respected. All participants are free to withdraw at any time.  
6.3 
Confidentiality 
The Principal Investigator will preserve the confidentiality of participants taking part in the 
study and fulfil transparency requirements under the General Data Protection Regulation for 
health and care research. Data and all appropriate documentation will be stored for a 
minimum of 10 years after the completion of the study, including the follow-up period.   
 
6.4 
Indemnity 
Imperial College London holds negligent harm insurance policies which apply to this study. 
 
6.5 
Sponsor 
Imperial College London will act as the main sponsor for this study. 
 
6.6 
Funding 
Imperial College London (ICL) are funded through the Discover-NOW Health Data Research 
Hub, of which Imperial College Health Partners (ICHP) are lead partner and Imperial College 
London are an academic partner. Discover-NOW is funded by a grant from the UK Research 
and Innovation (UKRI) Industrial Strategy Challenge Fund (ISCF). Partial additional funding 
for the study (i.e., additional to the Hub grant funding) has been provided directly by ICHP. 
 

 
 
 
 
 
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We expect Imperial College London’s research study budget to be 135,000 GBP based on 
the activities and approach outlined above. The study’s funding is covered under the term’s 
of the Consortium Agreement relating the Discover-NOW Digital Innovation Hub entered into 
between Imperial Collee of Science, Technology and Medicine and ICHP effective 20 
November 2019.  
 
This consortium was formed in connection with the Parties’ successful application in 
response to the Digital Innovation Hub Prospectus issued by the Medical Research Council 
(MRC) on behalf of UK Research and Innovation (UKRI), working together with Health Data 
Research UK Limited (HDRUK), for funding through the Industrial Strategy Challenge Fund 
(ISCF). 
 
6.7 
Audits  
The study may be subject to inspection and audit by Imperial College London under their remit 
as sponsor. 
 
7. Publication policy 
The Investigators and representatives of the collaborating organisations will be involved in 
reviewing drafts of the manuscripts, abstracts, press releases and any other publications 
arising from the study. Authors will acknowledge that the study funding as detailed in Section 
6.6 above. Authorship will be determined in accordance with the ICMJE guidelines and other 
contributors will be acknowledged.

 
 
 
 
 
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Appendix 1: Fresh Start overview 
 
 

 
 
 
 
 
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Step
Patient 
search 
Outreach, 
Qualification 
& Booking
Onboard
Know 
Diabetes 
Emails
Huma App and 
Devices
Virtual Group Consultations (VGC)
12wk Review
Discharge, 
Repeat or 
MDT
Before
During
After
Staff actions 
at primary 
care practice
Run EPR 
search 
report to 
find list of 
patients.
Contact 
patients by 
phone, invite 
them to the 
service and 
ensure they 
can 
participate.
Book them 
onto a formal 
onboarding 
appointment 
and book 
bloods if 
missing.
Book to collect 
devices.
Run virtual 
appointment 
or phone call 
to onboard 
patient onto 
the service.
Provide Huma 
app, book 3 x 
VGC sessions, 
sign up for 
Know Diabetes 
emails, answer 
questions
Patient collects 
devices from 
practice.
Sign the 
patient up by 
email and 
make sure 
they are 
receiving 
emails OK.
Check Huma 
clinician 
dashboard 
daily for safety 
(red flags) and 
to see whether 
patients are 
using app.
Escalate care if 
red flag 
spotted.
Patients set 
their own 
goals.
Look at Huma 
dashboard, 
move some 
key data into 
EPR.
Fill out VGC 
“discussion 
board” slide 
and agree 
talking points 
for VGC 
session.
Discuss 
possible 
clinical and 
care plan 
decisions.
Run VGC 
session with 6-
10 patients.
Review and 
discuss patient 
goals and 
clinical 
metrics.
Identify and 
note clinical 
treatment or 
care plan 
changes and 
referrals 
required.
Internally 
discuss notes 
and actions 
from VGC after 
session.
Refer to 
clinical 
protocols; 
agree and 
action any 
required care 
plan and 
treatment 
changes or 
referrals.
Decide 
whether to 
discharge 
patient, repeat 
service for 12-
weeks or 
escalate them 
to an MDT for 
further 
support.
How long it 
should take?
5m 
total
10m 
per patient
30m-45m 
per patient
1m 
per patient
1-2m 
per patient
1hr
total
1hr15m
total
1hr
total
1hr
total
How often it 
should be 
done?
Once, at 
beginning of 
12 weeks
Once, at 
beginning of 
12 weeks
Once, at 
beginning of 
12 weeks
Twice, at 
beginning and 
at first VGC 
session
Daily
Before each 
VGC
During each 
VGC
After each VGC
Once, at end 
of 12 weeks
+
Appendix 2: Overview of study procedures 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
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Appendix 3: Example VGC discussion board 
 

 
 
 
 
 
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Appendix 4: References 
 
 
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Gudnason V, Thompson SG, Sattar N, Selvin E, Hu FB, Danesh J; Emerging Risk Factors 
Collaboration. Diabetes mellitus, fasting glucose, and risk of cause-specific death. N Engl J Med. 2011 
Mar 3;364(9):829-841. doi: 10.1056/NEJMoa1008862. Erratum in: N Engl J Med. 2011 Mar 
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2 The Emerging Risk Factors Collaboration. Association of Cardiometabolic Multimorbidity With 
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Gudbjörnsdottir, M.D., Ph.D. Risk Factors, Mortality, and Cardiovascular Outcomes in Patients with 
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12 Assessing Psychosocial Distress in Diabetes. Development of the Diabetes Distress Scale. William 
H. Polonsky, PHD, CDE1, Lawrence Fisher, PHD2, Jay Earles, PSYD3, R. James Dudl, MD4, Joel 
Lees, MD5, Joseph Mullan, PHD2 and Richard A. Jackson, MD6. Diabetes Care 2005 Mar; 28(3): 626-
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