Diabetes Mellitus, Type 2NCT04198935
Evaluating a Digital Diabetes Education Program
A study testing Span Health Mobile Application in people with Diabetes Mellitus, Type 2, run by Adam Bataineh.
Trial summary
The first line of treatment for patients with type 2 diabetes usually entails referral for diabetes education which has been shown to improve outcomes. The National Diabetes Audit 2016-17 showed an increase in the percentage of patients with type 2 diabetes who are offered a diabetes education program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Span Health Mobile Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2020to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes
- Have access to and feel comfortable using a smart phone
Who cannot join
- Patients who cannot use a smart phone or mobile phone texting functions.
- Patients on SGLT2 inhibitors (Gliflozins)
- Patients taking insulin
- Patients already undergoing face-to-face structured education at the time of the study
- Patients with diagnosed heart failure or chronic kidney disease
About this study
Official title: Evaluating a Digital Diabetes Education Program Based on Individualized Carbohydrate Management
The first line of treatment for patients with type 2 diabetes usually entails referral for diabetes education which has been shown to improve outcomes. The National Diabetes Audit 2016-17 showed an increase in the percentage of patients with type 2 diabetes who are offered a diabetes education program. Despite this, the percentage of recorded attendance was only 7%.
Digitally delivered interventions have the potential to solve the problem of adherence to education programs. Digitally delivered diabetes prevention programs have been shown to have higher participation than in-person programs. As a solution to this we propose a structured diabetes education program based on individualized carbohydrate management delivered through a mobile application. The clinical approach is based on multiple clinical trials demonstrating its effectiveness and is in line with the most recent NICE guidelines.
Read more
The investigator interviewed a group of general practitioners and patients to identify the target group most suited for this solution. Three groups of patients were identified who would benefit the most from a digital diabetes education program. The first group are patients who have declined face-to-face education for any reason. The second group are patients who are on a waiting list for face-to-face education but will not receive it. The third group are patients who have undergone in-person education but have not clinically improved.
To evaluate the acceptability of this approach among patients with diabetes type 2 the investigators will use a Net Promoter Score survey. Adherence to the program will be assessed by measuring the percentage of people completing the whole 3 months. We will also evaluate whether this approach improves patient outcomes as measured by NICE defined treatment targets for glucose control, blood pressure and blood cholesterol. Secondary aims include comparing healthcare resource utilization. Outcomes are to be measured at baseline and at the completion of the 12 week program. Clinical outcomes to be measured are: body weight, blood pressure, Haemoglobin A1c (HbA1c), total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides level.
Read the detailed description
In 2019 the Secretary of State for Health and Social Care commissioned The Topol Review: Preparing the healthcare workforce to deliver the digital future which recommended the adoption of digital medicine to improve National Health Service (NHS) services and face the future challenges facing the NHS. Among these challenges is the increasingly alarming burden of type 2 diabetes mellitus (T2DM) on the NHS with more than 4 million people diagnosed with disease and 12 million with pre-diabetes across the United Kingdom (UK). The National Institute of Clinical Excellence (NICE) encourages the adoption of individualized approaches to diabetes care that are tailored to the needs of patients with type 2 diabetes through structured education programs that are evidence based.
Standard practice across the UK is to offer patient with T2DM face-to-face structured education such as DESMOND (Diabetes Education and Self-Management for On-going and Newly Diagnosed) and the X-pert Health program. These programs follow a face-to-face structured group education session format.
The National Diabetes Audit 2016-17 showed an increase in the percentage of patients with T2DM who are offered a diabetes education program with more ore than 90% of people diagnosed with T2DM being offered structured education. Despite this, only 7% of these patients recorded an attendance.
Digitally delivered interventions have the potential to solve the problem of adherence to education programs. Digitally delivered diabetes prevention programs have been shown to have higher participation than in-person programs. The digital nature of these interventions allows them to be delivered at scale and at a lower cost when compared to in-person programs. NICE puts great emphasis on individualization of recommendations delivered to patients.
The investigators propose a digitally delivered diabetes education program based on individualization of carbohydrate intake through regular interactions with a trained nutritionist via text messaging. The program follows a clinical approach based on low-carbohydrate and low glycemic index diet recommendations which has been shown to have better participant retention, greater weight loss and better T2DM outcomes when compared to other dietary approaches. It is also in line with the latest National Institute for Health and Care Excellence (NICE) guidelines and recommendations.
The investigators interviewed a group of general practitioners and patients to identify the target group most suited for this solution. Three groups of patients were identified who would benefit the most from a digital diabetes education program. The first group are patients who have declined face-to-face education for any reason. The second group are patients who are on a waiting list for face-to-face education but will not receive it. The third group are patients who have undergone in-person education but have not clinically improved.
Participants will be invited to download the Span Health mobile application (app). The app delivers educational content on diabetes and nutrition in a structured format in a 12 week long program.
Participants will be invited to have a 1-to-1 consultation with a nutritionist through the app at the beginning of the program where they will set goals and expectations and a nutritional plan. They will have weekly consultations to track their progress. The app also allows participants to ask questions via text messaging at any time which would be directed to a nutritionist who will provide an answer.
The app allows for personal tracking of self-measured blood glucose and ketone levels. It also contains tools for fasting tracking and nutritional information on common foods along with a library of food recipes.
The Span Health program is based on individualized carbohydrate management which aims to train participants to adopt a low-carbohydrate diet taking into account the patient's self-measured biometrics and individual tolerances and circumstances.
To evaluate the acceptability of this approach among patients with diabetes type 2 the investigators will conduct a single arm non-randomised controlled trial recruiting a number of patients to use the service. Qualitative outcomes will be measured using a Net Promoter Score survey based on a 0 to 10 scale with a higher score indicating a more favorable outcome. Adherence to the program will be assessed by measuring the percentage of people completing the whole 3 months. They will also evaluate whether this approach improves patient outcomes as measured by NICE defined treatment targets for glucose control, blood pressure and blood cholesterol. Outcomes are to be measured at baseline and at the completion of the 12 week program. Clinical outcomes to be measured are: body weight, blood pressure, fasting blood glucose, Haemoglobin A1c (HbA1c), total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides level.
Despite the increasing availability of digitally delivered diabetes education programs, most practices still offer in-person programs. Which the increasing burden of diabetes on the NHS. it is wise to start thinking about more scalable solutions that utilize digital medicine to approach this problem. This relatively novel approach if proven to be beneficial could lead to wider studies and a discussion on changing the current approach recommended by NICE.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Span Health Mobile Application
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Span Health Mobile ApplicationDevice
A 12 week structured diabetes education program for type 2 diabetes delivered through a mobile application. The application also allows for interaction with a registered nutritionist via text messaging.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will be enrolled on to a 12 week structured diabetes education program for type 2 diabetes delivered through a mobile application. The application also allows for interaction with a registered nutritionist via text messaging. Receives: Device: Span Health Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Change from baseline weight in kilograms at 3 months
Measured: 3 months
Blood pressure
Change from baseline systolic blood pressure in millimeters of mercury (mmHg) at 3 months
Measured: 3 months
Hemoglobin A1C (HbA1C) level
Change from baseline HbA1C level in mmol/mol at 3 months
Measured: 3 months
Lipid profile
Change from baseline lipid profile (including total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides level in mg/dL) at 3 months
Measured: 3 months
Participant's experience
To assess the experience of participants using a Net Promoter Score survey based on a 0 to 10 scale with higher scores indicating a more favorable outcome
Measured: 3 months
Adherence to the the program
Adherence to the program will be assessed by measuring the percentage of the program completed by the participant.More than 80% of the program completed will be considered adherent to the program.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study startMay 2020 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adam Bataineh
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Adam Bataineh, Span Health
- Investigators
- Adam Bataineh, MD MSc, Study director, Span Health, East Suffolk and North Essex NHS Foundation TrustSumbal Babar, MBBS, Principal investigator, East Tennessee State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198935
- Sponsor's protocol ID
- 0000001
- Status last verified
- Dec 2019
- First submitted
- 22 Nov 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Digital Diabetes Education Program Based on Individualized Carbohydrate Management
- ClinicalTrials.gov ID
- NCT04198935
- Acronym / sponsor ID
- 0000001
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Adam BatainehIndustry (pharma, biotech, devices)
- Study start
- May 2020 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The first line of treatment for patients with type 2 diabetes usually entails referral for diabetes education which has been shown to improve outcomes. The National Diabetes Audit 2016-17 showed an increase in the percentage of patients with type 2 diabetes who are offered a diabetes education program. Despite this, the percentage of recorded attendance was only 7%.
Digitally delivered interventions have the potential to solve the problem of adherence to education programs. Digitally delivered diabetes prevention programs have been shown to have higher participation than in-person programs. As a solution to this we propose a structured diabetes education program based on individualized carbohydrate management delivered through a mobile application. The clinical approach is based on multiple clinical trials demonstrating its effectiveness and is in line with the most recent NICE guidelines.
The investigator interviewed a group of general practitioners and patients to identify the target group most suited for this solution. Three groups of patients were identified who would benefit the most from a digital diabetes education program. The first group are patients who have declined face-to-face education for any reason. The second group are patients who are on a waiting list for face-to-face education but will not receive it. The third group are patients who have undergone in-person education but have not clinically improved.
To evaluate the acceptability of this approach among patients with diabetes type 2 the investigators will use a Net Promoter Score survey. Adherence to the program will be assessed by measuring the percentage of people completing the whole 3 months. We will also evaluate whether this approach improves patient outcomes as measured by NICE defined treatment targets for glucose control, blood pressure and blood cholesterol. Secondary aims include comparing healthcare resource utilization. Outcomes are to be measured at baseline and at the completion of the 12 week program. Clinical outcomes to be measured are: body weight, blood pressure, Haemoglobin A1c (HbA1c), total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides level.
Detailed description
In 2019 the Secretary of State for Health and Social Care commissioned The Topol Review: Preparing the healthcare workforce to deliver the digital future which recommended the adoption of digital medicine to improve National Health Service (NHS) services and face the future challenges facing the NHS. Among these challenges is the increasingly alarming burden of type 2 diabetes mellitus (T2DM) on the NHS with more than 4 million people diagnosed with disease and 12 million with pre-diabetes across the United Kingdom (UK). The National Institute of Clinical Excellence (NICE) encourages the adoption of individualized approaches to diabetes care that are tailored to the needs of patients with type 2 diabetes through structured education programs that are evidence based.
Standard practice across the UK is to offer patient with T2DM face-to-face structured education such as DESMOND (Diabetes Education and Self-Management for On-going and Newly Diagnosed) and the X-pert Health program. These programs follow a face-to-face structured group education session format.
The National Diabetes Audit 2016-17 showed an increase in the percentage of patients with T2DM who are offered a diabetes education program with more ore than 90% of people diagnosed with T2DM being offered structured education. Despite this, only 7% of these patients recorded an attendance.
Digitally delivered interventions have the potential to solve the problem of adherence to education programs. Digitally delivered diabetes prevention programs have been shown to have higher participation than in-person programs. The digital nature of these interventions allows them to be delivered at scale and at a lower cost when compared to in-person programs. NICE puts great emphasis on individualization of recommendations delivered to patients.
The investigators propose a digitally delivered diabetes education program based on individualization of carbohydrate intake through regular interactions with a trained nutritionist via text messaging. The program follows a clinical approach based on low-carbohydrate and low glycemic index diet recommendations which has been shown to have better participant retention, greater weight loss and better T2DM outcomes when compared to other dietary approaches. It is also in line with the latest National Institute for Health and Care Excellence (NICE) guidelines and recommendations.
The investigators interviewed a group of general practitioners and patients to identify the target group most suited for this solution. Three groups of patients were identified who would benefit the most from a digital diabetes education program. The first group are patients who have declined face-to-face education for any reason. The second group are patients who are on a waiting list for face-to-face education but will not receive it. The third group are patients who have undergone in-person education but have not clinically improved.
Participants will be invited to download the Span Health mobile application (app). The app delivers educational content on diabetes and nutrition in a structured format in a 12 week long program.
Participants will be invited to have a 1-to-1 consultation with a nutritionist through the app at the beginning of the program where they will set goals and expectations and a nutritional plan. They will have weekly consultations to track their progress. The app also allows participants to ask questions via text messaging at any time which would be directed to a nutritionist who will provide an answer.
The app allows for personal tracking of self-measured blood glucose and ketone levels. It also contains tools for fasting tracking and nutritional information on common foods along with a library of food recipes.
The Span Health program is based on individualized carbohydrate management which aims to train participants to adopt a low-carbohydrate diet taking into account the patient's self-measured biometrics and individual tolerances and circumstances.
To evaluate the acceptability of this approach among patients with diabetes type 2 the investigators will conduct a single arm non-randomised controlled trial recruiting a number of patients to use the service. Qualitative outcomes will be measured using a Net Promoter Score survey based on a 0 to 10 scale with a higher score indicating a more favorable outcome. Adherence to the program will be assessed by measuring the percentage of people completing the whole 3 months. They will also evaluate whether this approach improves patient outcomes as measured by NICE defined treatment targets for glucose control, blood pressure and blood cholesterol. Outcomes are to be measured at baseline and at the completion of the 12 week program. Clinical outcomes to be measured are: body weight, blood pressure, fasting blood glucose, Haemoglobin A1c (HbA1c), total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides level.
Despite the increasing availability of digitally delivered diabetes education programs, most practices still offer in-person programs. Which the increasing burden of diabetes on the NHS. it is wise to start thinking about more scalable solutions that utilize digital medicine to approach this problem. This relatively novel approach if proven to be beneficial could lead to wider studies and a discussion on changing the current approach recommended by NICE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Span Health Mobile ApplicationParticipants will be enrolled on to a 12 week structured diabetes education program for type 2 diabetes delivered through a mobile application. The application also allows for interaction with a registered nutritionist via text messaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with type 2 diabetes
- Have access to and feel comfortable using a smart phone
Key exclusion criteria (5 listed)
- Patients who cannot use a smart phone or mobile phone texting functions.
- Patients on SGLT2 inhibitors (Gliflozins)
- Patients taking insulin
- Patients already undergoing face-to-face structured education at the time of the study
- Patients with diagnosed heart failure or chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Span Health Mobile ApplicationA 12 week structured diabetes education program for type 2 diabetes delivered through a mobile application. The application also allows for interaction with a registered nutritionist via text messaging. | Device | Intervention |
Primary outcome
Change in weight
Time frame: 3 months
Change from baseline weight in kilograms at 3 months
Blood pressure
Time frame: 3 months
Change from baseline systolic blood pressure in millimeters of mercury (mmHg) at 3 months
Hemoglobin A1C (HbA1C) level
Time frame: 3 months
Change from baseline HbA1C level in mmol/mol at 3 months
Lipid profile
Time frame: 3 months
Change from baseline lipid profile (including total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides level in mg/dL) at 3 months
Participant's experience
Time frame: 3 months
To assess the experience of participants using a Net Promoter Score survey based on a 0 to 10 scale with higher scores indicating a more favorable outcome
Adherence to the the program
Time frame: 3 months
Adherence to the program will be assessed by measuring the percentage of the program completed by the participant.More than 80% of the program completed will be considered adherent to the program.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Bataineh, MD MSc study director
Span Health, East Suffolk and North Essex NHS Foundation Trust
Sumbal Babar, MBBS principal investigator
East Tennessee State University
Questions about this trial
What is this clinical trial studying?
A study testing Span Health Mobile Application in people with Diabetes Mellitus, Type 2, run by Adam Bataineh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.