Type 2 Diabetes randomised control trial results

Type 2 Diabetes randomised control trial results

Using our patient management software and connected self-management app to deliver positive health outcomes for patients with type 2 diabetes in the northwest of England in partnership with local primary care providers, Greater Manchester Clinical Research Network and regional investors.

This blog post explains our 5 year journey working in partnership with GP practices, primary care networks, GP Federations, and local communities to co-create Healum’s personalised digital care and support solutions for patients with type 2 diabetes in the north west of England.

It outlines how we leveraged support from Greater Manchester Clinical Research Network, Innovate UK, the NIHR, Northern Powerhouse Investment Fund and Greater Manchester Cheshire and Life Sciences fund, to finance, sponsor and deliver a Randomised Control Trial that ultimately showed improved patient outcomes, increased patient engagement and improved quality of life. It then goes on to explain how we then used that work to create a real-world live-learning network that will enable primary care sites across the north of England and beyond to share insights and learnings for generating intelligent personalised plans of care and self-management, in a way that can both alleviate workforce pressure and improve health outcomes.

Our work with Vernova CIC, NIHR and GP surgeries in Eastern Cheshire in evaluating the usage of Healum’s software for healthcare professionals working in primary care to improve health outcomes and experiences for their patients with type 2 diabetes through a patient facing mobile app connected to a personalised plan of care and support shows the following results:

  • Patients that used the Healum app reduced their HbA1c by 7.37% vs an increase of 1.75% in the control group over 6 months
  • Patients that used the Healum app saw an improvement in quality of life measured by an average change in their pre- to post-trial EQ VAS score of 8.2%
  • Patients had a better care experience from additional support through the app with 6,797 healthy choices taken by patients
  • Multidisciplinary teams in primary care were able to efficiently motivate and educate patients with resources being shared 5,396 times and then viewed over 2,200 times
  • Primary care staff were able to understand their patients’ needs better: 1,000 actions completed, 343 goals joined, and over 2,200 resource views.

These results are the culmination of a journey that exemplified best practice at every step of the way. Here is the story:

Healum’s Purpose

Healum is a digital health company with a mission to improve the health outcomes and quality of life of millions of people through its digital solutions that enable health professionals to deliver personalised proactive healthcare services for patients that motivate, empower and inform them to understand and make choices when managing their health. Making it easier for people to take control of their health in partnership with healthcare professionals is what everyone in our company gets out of bed in the morning to do. It’s what motivates us to endlessly improve our digital health platform in the service of supporting people’s right for personalised healthcare that addresses their needs and supports them in making the choices that can have the biggest impact on their health outcomes and those of their families.

Solving the problem of health choice

Every individual is faced with millions of small choices that span over millions of moments in their lives. The choices we make form our lived experiences, lead to emotional responses, and engender behaviour patterns that dictate how likely we are to live the healthy and happiest life possible, given our endowments of DNA, our location, our socioeconomic circumstances and our mindset. One of the biggest challenges that we face as individuals when trying to be as healthy as possible, is to understand the best possible choices that are most likely to result in the best possible health outcomes. If that wasn’t hard enough, then trying to make those choices at the appropriate moments each day, week, month and year of our lives is a colossal task, one made harder by years of ingrained habits and conditioning. 

At Healum we believe in supporting people who want to manage their health to work in partnership with trusted healthcare professionals, to better understand the best possible choices that are available to them, and to be able to put these choices into practice at the moments that matter during their lives. By providing our health management and behaviour change software to healthcare professionals we aim to support them in delivering personalised approaches to patient self-care through the Healum mobile app. 

We developed a health platform that supports people with long term conditions and type 2 diabetes to make informed and personalised health choices underpinned by behaviour change platform that empowers each patient to act those choices, in partnership with the network of healthcare professionals that are involved in their care across primary, secondary and community care settings. 

The role of primary care in supporting patients with type 2 diabetes to make healthy choices that enable them to manage their diabetes

During the period of time that Healum was engaged in co-creation with patients with type 2 diabetes and healthcare professionals in attempting to discover what would work best for patients, one very strong insight kept coming through time and time again…

People with type 2 diabetes would explain that they had such little time with healthcare professionals compared to the amount of time they spend in their daily lives, and that it was really hard to take the advice given in those short moments and apply it to their daily lives.

In fact if one adds up time spent with a healthcare professional for an average patient with type 2 diabetes,  it amounts to around 4 hours a year vs 8,876 hours living their daily lives. This key insight and key challenge led us to imagine:

“What if we were able to make the moments that occur within those 4 hours with the many different healthcare professionals in a patient’s journey, translate into better self-management during the 8,876 hours that people with type 2 diabetes are living their lives?”

Patient participation and engagement work with over 50 patients across 2 years also helped us to qualify the following statements from patients:

  • “We are not always aware of the full range of services and options that we have to manage our diabetes”
  • “Getting advice and support when we need it is challenging”
  • “Information and advice that we are given is not tailored or personal”
  • “There is a lot of noise about what are the best ways to manage my diabetes.”
  • “Making healthy choices and learning about how to manage our diabetes costs a lot of money and takes a lot of time.”

Our co-creation process also saw us work with over 100 healthcare professionals across primary care. We crystalised some of the challenges that they face when supporting patients with type 2 diabetes into these statements:

  • Staff working in primary care are being asked to support self-management of patients with type 2 diabetes without the time or effective tools to do so.
  • Staff working in primary care have constrained capacity and limited time to spend with each patient that has type 2 diabetes which makes having personal empathetic conversations harder and personalised treatment plans even harder 
  • New roles such as Link Worker, Social Prescriber and health and wellbeing coaches are not being fully utilised for the roles they can play in supporting joined up care for patients with diabetes
  • There is a lack of insight into how patients are managing their health and well-being when they are living their daily lives, so its hard for healthcare professionals working in primary care to really understand how a patient is doing and what strategies work best. 
  • There is no system to create joined up plans of digital care that aggregate all of the self-management resources and align them to what patients want from their care.

Using digital personalised care plans in primary care to support patients with type 2 diabetes

The philosophy of personalised care planning has been proven to be effective at improving the health of people with diabetes. Effective personalised plans are broad in scope as they are required to join up care across primary, secondary, community, mental health and social care systems. Interventions that are delivered as part of that care are broad and include drugs, procedures, educational strategies, social prescribing, statutory and non-statutory services, diet and lifestyle. It is a challenge to incorporate all of these options into one plan that patients can access wherever and whenever they want in a way that enables all the relevant members of the primary care team to view and contribute to. 

  • Healthcare professionals working in primary care reported that there are significant financial, organisational, IT and time barriers amongst multidisciplinary teams (MDTs) of healthcare professionals in primary care that make it hard to co-create integrated plans of care and education for people with Type 2 Diabetes. Notably:
  • Patients discarded or lost the paper based care plan.
  • There was no record of the paper based care plan for the clinicians to refer to the next year
  • Care plans were an annual one way conversation rather than something patients could access and incorporate into their lives each day
  • The limited space of the paper did not enable a healthcare professional to capture the full set of resources available to patients

Opportunities for innovation around personalised care planning and self-management for patients with type 2 diabetes. 

In 2018 we finished the feasibility phase of our research and development which helped to define our future pathway for research and development. Our co-creation process with healthcare professionals and patients formed the basis of the design for the Healum software and apps to achieve the following use cases:

  • Help patients have a better understanding of their diabetes and their health in a way that is personal to them.
  • Help patients access personalised support in between appointments with doctors and nurses
  • Provide patients with help to navigate the many health choices in their daily lives and cut through the noise of the conflicting and competing sources of advice
  • Turn patient care plans into a dynamic daily tool that they can access wherever and whenever they want 
  • Enable all healthcare professionals to quickly and easily access, input and manage the care plans of patients in a way that saves them time and can be done inside their existing systems – in this case EMIS.

How big is the problem with type 2 diabetes that this would solve?

  • As per the Department of Health, over 16 million people in England have an incurable long term condition and over 3m of those have 3 or more long term conditions.
  • People with long term conditions account for circa 50% of GP appointments, 64% of outpatient appointments and 70% of inpatient bed days. 
  • Treatment of long term conditions takes-up £7 in every £10 of total health and social care expenditure.
  • There 3.9 million people living with type 2 diabetes in the UK (see here), with an estimated 1 million undiagnosed patients (see here).
  • Inequalities are inherent in the prevention, detection, care and outcomes of patients diagnosed with Type 2 Diabetes. 
  • People in more deprived communities are more likely to develop Type 2 Diabetes. 
  • Unfortunately, many people living with type 2 diabetes do not access the appropriate services that are available to them in the community or from primary and  secondary care, and many of them do not know what is available.
  • Additionally, there is a huge variation in the delivery of the nine care processes, such as foot checks, weight checks, retinal screening and cholesterol management, that are expected to be followed for people living with diabetes.

When is the Healum software designed to be used by primary care staff?

At the following moments when there is an opportunity to provide fast, personalised, consistent, light-touch self-care support:

  • During Diabetes annual reviews
  • After an NHS Health Check
  • After someone is diagnosed with type 2 diabetes 
  • During any routine appointments for diabetes care
  • During Link-worker or health and wellbeing coach appointments
  • Info sharing after a medication review

What can patients use the product to do?

  • Access health education content recommended by the GP Practice
  • Tick off personalised daily actions as part of health goals
  • Discover and access services around them 
  • See and understand their test results.
  • Track health outcomes and progress

What can staff in primary care settings use the product to do?

  • Create digital personalised care plans with individual patients that contain resources, goals and actions all linked to their health objectives, which can be shared directly to them through the app.
  • Create and share customisable SMART goals and actions to patients and then can track patient progress towards these.
  • Share articles, videos, recipes and local places, personalised to each patient to enable them to learn more about self-managing their condition.
  • Track health metrics at home to keep on top of goals, which HCPs can then view in the software to know how patients are getting on in between appointments.

Healum’s approach to its research roadmap

With the aid of NIHR and NICE Evidence Standards Framework, Healum were able to create a roadmap of research and evaluation for the type of digital health intervention that Healum is categorised as. Namely digital health interventions that inform and drive clinical management.

Healum identified the National Institute for Health Research as important partners and enablers that would support us in the implementation of our plans to build an evidence base covering the efficacy, usability, safety and value of our core product including its benefits for patients, healthcare professionals and integrated care systems.

The NIHR supported us in our research approach, in our identification and engagement with research sites, in our study design, in helping us to find a Chief Investigator, and in providing us with the tools we needed to manage budgets and undertake our responsibilities as a sponsor. The NIHR also helped us with our study recruitment which was made more challenging during the COVID pandemic. Healum is incredibly grateful to the huge efforts of the many people within the NIHR who went above and beyond their day jobs to help in all aspects of our research work. The biggest help came from the Greater Manchester Clinical Research Network who were extremely helpful in aiding Healum to develop a partnership with Vernova CIC – a Federation that provides primary care services in Eastern Cheshire. They also introduced us to Dr Adrian Heald who we chose as the Chief Investigator of the study. 

With the aid of healthcare researchers across greater Manchester including Dr Adrian Heald, Professor Peter Bower of Centre for Primary Care, (part of the NIHR School for Primary Care Research),  and Professor Paul Wallace, (formerly Director of the NIHR Primary Care Research Network), Healum were able to design a study that met the requirements outlined in the NICE Evidence Standards Framework for suitable to validate the efficacy of a Tier C digital health technology that informs and drives clinical management.

Building a research consortium in the north west of England

In 2019 Healum and Vernova CIC won UKRI-funded project, under the Digital Health Technology Catalyst (DHTC) programme, part of the Medicines Manufacturing Challenge, helped the company to fund a Randomised Control study to explore the impact and efficacy of the Healum Collaborative Care planning Software and App on condition management in the Type 2 Diabetes Mellitus Population in NHS Primary Care.

Healum worked with a consortium of the following stakeholders were involved in the randomised control trial in the following ways:

  • Healum provided the digital care and support planning system integrated with EMIS and linked to a patient facing mobile app that enabled patients to manage their day to health choices
  • Vernova CIC as a GP Federation organised the approach to recruitment and provided principal investigators across 15 GP practices in Eastern Cheshire.
  • Dr Adrian Heald was assigned as Chief investigator of the study
  • Greater Manchester NIHR CRN supported the all of the organisations to deliver the study from start to finish

Research Aims

Healum chose to invest in sponsoring a randomised control trial that had the aim of evaluating:

  • the impact of its care planning software and self-management apps on health outcomes for patients with type 2 diabetes 
  • the impact of its care planning software and self-management apps on quality of life for patients with type 2 diabetes 
  • the mechanisms by which the functions of its care planning software and self-management apps had an impact on supporting patients to make healthy choices
  • the mechanisms by which the functions of its care planning software and self-management apps had an impact on supporting healthcare professionals to provide joined up care in a more efficient way.

Study design overview

Healum worked with the Chief investigator of this study to devise a protocol that was fit for evaluating the digital solution to meet the above aims . Standard RCT methods to evaluate outcomes and quality of life were chosen, alongside a methodology that was fit to evaluate the use cases of the digital product. Unlike the study of drugs or devices, digital products have unique attributes that play a role in research outputs and require a more agile approach. The below arrangements describe the study design:

Trial TitleA randomised control study to explore the impact and efficacy of the Healum Collaborative Care planning Software and App on condition management in the Type 2 Diabetes Mellitus Population in NHS Primary Care
Clinical Phase Post diagnosis disease management
Trial DesignRandomised control study with usual care & active group
Trial ParticipantsAdult patients with Type 2 Diabetes that don’t have complications
Planned Sample SizeRange of 125-150 control, Range of 125-150 control
Intervention Duration6 months
Qualitative StudyTen 1 on 1 interviews with patients

ObjectivesOutcome Measures
PrimaryTo compare HbA1c, BMI, weight, lipid profile, quality of life and patient activation of an active group (app users) vs an anonymised control group (usual care – no app) over a 6 month periodHbA1c, BMI, weight, lipid profile, quality of life and patient activation
To evaluate the impact on the key components of the intervention on patient self-management:  including but not limited to: -Motivation-capabilities -activation of healthy behaviours. QOL Survey: using the Healum Diabetes survey (combination of the EQ5D5L survey and Pam’s survey)NHS Patient Activation Measure QuestionnaireIn-app analytics measuring engagement and content/service usagePositive or negative statements around use cases of the app, discussed as part of a focus group

Participants with HbA1c greater than 58 mmol/mol were randomised to either the active intervention group or the control group receiving usual care. The intervention group received a personalised care plan created with a healthcare professional, involving daily lifestyle prompts and offering access to a range of online resources via an app. Randomisation did not influence other decisions about diabetes management.

The following use cases in relation to the headline outcomes were evaluated in the study:

Headline outcomeMechanism
Improving health outcomes and improve patient self-care capabilitiesEnabling patients to easily access and incorporate the resources, support and advice from their care planning appointment into their daily lives, in a way that helps them to achieve the health objectives and goals that matter most to them, at any time and in any location through the Healum smartphone app.
Improving patient experience, improve patient motivation and shifting the burden of care in a supportive wayPromoting empathetic conversations between patients and the team of healthcare professionals working in their GP surgery, as part of the shared digital plan of care and support, built around the objectives that matter most to each patient.
Improving clinical efficiency of care planning across Primary Care NetworksProviding a digital record of care planning that multidisciplinary teams in Eastern Cheshire can input into, in order to make the most of link workers, healthcare assistants, health and wellbeing coaches, practice nurses and GPs in the delivery of routine care; and which provides continuity of personalised care over time when as staff leave and join the practice.

Results and Impact of the study

The GP Practices that have been part of the rollout in Eastern Cheshire have been able to deliver personalised care plans to people living with type 2 diabetes, providing them with the resources, education and support they need. The results were as follows:

1. Patients in the treatment group saw improved health outcomes measured by reductions in HBA1c and reductions in BMI.

The study results reveal that patients who received a digital plan of care had better outcomes than those who didn’t. On average, patients who used the digital care plans through their app were able to lower their blood glucose levels (Hb1Ac) by an average of 7.37% (±se 1.40%), compared with an increase of 1.75% (±se 2.05%) for the control group who received standard care over the 6 months.  The average percentage change in BMI  was -0.66% (±se 0.42%) for active treatment and -0.23% (±se 0.52%) for the control group. 72.41% of the active treatment group reduced their HbA1c, compared to just 41.54% of the control group. For BMI, 55.41% of the active treatment group had a reduction, compared to 50% for the control group.

2. Patients that used the Healum app saw an improvement in quality of life (QoL)

Patients with app access had improvements in both EQ5D5L and EQ VAS, two measures of self-rated QoL. Patients with a care plan and app had an average change in their pre- to post-trial EQ5D5L score of 0.0464, compared to -0.0086 for patients’ without the app, and an average change in their pre- to post-trial EQ VAS score of 8.2%, compared to -2.8% for those without the app. 

3. Patients had a better care experience from additional support through the app

The popularity and value of the app in providing support is shown by users completing 2,078 sessions, with 30% of users using the app at least 10 times and 84% at least twice in the first 30 days. Using the Healum app had a positive impact on patients engaging in the management of their diabetes.

4. Multidisciplinary teams were able to better motivate and educate patients in a light touch way

Across the 103 app users, 280 useful goals were agreed and shared in care plans, with a further 343 goals then joined in the app, such as “To be healthy enough to have a safe pregnancy”. Resources were shared 5,396 times and viewed over 2,200 times, including “1-minute omelette”. 

5. Primary care staff were able to understand their patients’ needs better

Actionable insights were generated from patient monitoring, involving 6,279 healthy choices and actions undertaken by app users (average of 61 per user), a combination of over 1,000 actions completed, 343 goals joined, over 2,400 trackers used and over 2,200 resource views.

To read the peer reviewed study you can go to Diabetes Therapies Journal or you can request to download the full evaluation write up here.

Findings from the qualitative study

10 patients were interviewed about their experiences using the app. Some of the quotes are shared here:

“The act of thinking of and capturing goals I think was really good. Before this, I didn’t feel as if anyone had asked me those questions. I didn’t really consciously think about them until the app presented the opportunity. So that was one big positive impact on me at the start.”

“I think the app is a very useful tool – it has the right things on there to help and motivate you.”

“Having the app has made me feel more motivated. Before, whenever I went to the GP, it was all about the drugs I must take and that was it. I was never really told about the things I could do myself to help my diabetes management. However, during the care plan appointment and having the app, I was informed about other things I could do. It’s been a helpful reminder to do things myself to help my health.”

Regional approach to financing, disseminating and scaling this work

Healum’s regional approach to its research, set it on a path to locating its HQ in Manchester. As a company we made a strategic decision in 2020 to tap into the wealth of research and technical development talent in the region. With a devolved health and social care budget, a streamlined innovation adoption pathway through Health Innovation Manchester, an effective GM clinical research network, a shared integrated health and social care record, and strong clinical and AI talent, it made sense for Healum to locate in Manchester, and to scale its offering in partnership with the NHS and life science organisations in the region. Healum honed its offering and its go to market plan, when it took part in the Greater Manchester Future of Healthcare Programme run by UP Ventures Group. As a result of the programme Healum team were introduced to investors at Catapult Ventures and Maven Capital Partners who were able to bring together the support of the British Business Bank, the Northern Powerhouse Investment Fund and the Greater Manchester and Cheshire Life Sciences Fund by investing £800K to match the funds the Innovate UK had committed to the R&D.

This approach is a good example of finance, healthcare, local government, academia, industry, research and regional accelerators working together to deliver research, better care, innovative technology products and jobs in the region. The randomised control trial was helpful in galvanising a number of healthcare providers and agencies in the north west to help co-develop our product, contribute to our research and input into our plans for dissemination. Health Innovation Manchester helped introduce Healum to key players in Salford and Manchester Universities as part of its consortium building efforts. Following the work done with Vernova CIC, Healum was fortunate in being able to work with Howbeck CIC, Innovation Agency North West Coast and Salford University as part of its research consortium to secure follow-on funding for its real world evaluation, implementation and spread and adoption efforts.

Spread and adoption of Healum

Following the positive results from its randomised control trial, Healum has secured a contract to use its software and app to support primary care to provide self-management support for patients with type 2 diabetes and patients at risk of CVD. Vernova CIC, Howbeck CIC, Innovation Agency North West Coast and Lancashire and South Cumbria ICB,  are working with Healum to help identify over 80 innovative primary care networks that are keen to use Healum’s proven solutions in the provision of personalised care and self-management support for patients at risk of cardiovascular diabetes or diagnosed with type 2 diabetes.

Innovation and development of AI solutions to support self-management and clinical decision support

During its work on the Randomised Control Trial Healum conceived of a better way to provide healthcare professionals working in primary care with clinical decision-making support when putting together personalised care plans that combine clinical and self-management options for different types of patients. We observed that Healthcare professionals trust the wisdom and advice of other healthcare professionals. This led us to think:

“What if our software could present those best options based on all the past experiences from other healthcare professionals that have used the software to create care plans?”

“What if our algorithms could continuously learn from all the collective inputs of all the other healthcare professionals that have used the software to provide personalised care?”

Healum developed its live-learning network for healthcare professionals and patients to come together to share actionable insights, self-management strategies and the outcomes of what combinations of medical and non-medical support work to achieve the outcomes and experiences that people with long term conditions want. 

The insights that can be shared across the network are able to provide healthcare professionals with an understanding of what actions led to what outcomes for patients with similar health goals, long term conditions and ethnic backgrounds. 

Our approach is to ensure that the wisdom of healthcare professionals plays a part in training any machine learning algorithm and that any patients consent to being part of the network and are clear in their understanding of what their data is being used for, the benefits of that and that they have the necessary controls to manage the processing of their data. 

In summary our live learning network was developed to:

  • Enable healthcare professionals to see what other healthcare professionals have shared with similar types of patients. They can view what personalised strategies, including goals, actions, resources and services have worked for other patients.
  • Provide better patient recommendations by learning which recommendations have generated the best health outcomes with similar patients across ethnic and social deprivation groups.
  • Enable commissioners and care deliverers to view insights at an ICB, PCN or practice level in understanding different patient needs, behaviour, health activation and use of services.

Healum’s Approach to safe and Ethical AI

The benefits of this live-learning approach can only be realised through the trust and involvement of patients and healthcare professionals working in partnership on the development of AI solutions. From its inception Healum was able to take on board the views of patients and healthcare professionals as well as the policy recommendations from the UK health AI community.

Naturally, when developing our offering, we wanted to ensure that our AI solutions were designed to be safe, effective, reliable and relevant to the patient engaging with the service – and most of all trusted by them.  Our belief is that if patients see the benefits of being able to help others, they will be willing to share a lot more about their health.

Live-learning research network launch

At the start of 2023 we announced the opening up of our live learning network to healthcare professionals, researchers and commissioners working across Primary Care network, NHS trusts, integrated care systems, universities and local authority organisations that want to work with Healum, to research optimal care pathways amongst populations of opted in and fully consented patients.

The live learning network will enable us to offer a large longitudinal AI based research panel of patient data, in order to identify and share the optimal care strategies for improving health outcomes for patients with long term conditions and multimorbidity. These machine learning tools surface optimal care pathways for patients with one or more long term conditions. They are made available as part of the live-learning network in order to assist healthcare professionals and commissioners in understanding how to deliver personalised comprehensive, integrated care to different patient populations.

During 2023 and 2024, Healum will provide its care planning software, its patient facing apps and its live learning dashboard free for any healthcare partner that signs up to be part of the live learning research network.  The benefits from the use of the software and apps in delivering personalised care for patients with one or more long term conditions, as well as the learnings around the optimal care pathways for different patient populations, will be available for those healthcare professionals to use as part of their standard practice. In addition, the benefits from the research will be immediately accessible to those very patient and healthcare professional stakeholders that have made the research possible. These learnings can be used to inform commissioners around their population health strategies and to assist healthcare professionals at the point of care and show them some of what their clinical peers have been doing effectively with their patients.

We are inviting any practices, primary care networks or integrated care systems to use our personalised care planning software, connected apps and live learning system as part of their efforts to reduce health inequalities, improve health outcomes and reduce pressures on the primary care workforce.

In the meantime, Healum will continue working with clinicians, researchers and other healthcare workers in Greater Manchester, Cheshire, Merseyside and Lancashire, to ensure that its research and product offering is as insightful and impactful as possible in empowering patients to take control of their health. Email [email protected] if you want to get your practice involved.