Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-05-31
2020-08-31
Brief Summary
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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
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
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.
Span Health Mobile Application
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.
Interventions
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Span Health Mobile Application
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.
Eligibility Criteria
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Inclusion Criteria
* Have access to and feel comfortable using a smart phone
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Adam Bataineh
INDUSTRY
Responsible Party
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Adam Bataineh
Chief Medical Officer
Principal Investigators
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Adam Bataineh, MD MSc
Role: STUDY_DIRECTOR
Span Health, East Suffolk and North Essex NHS Foundation Trust
Sumbal Babar, MBBS
Role: PRINCIPAL_INVESTIGATOR
East Tennessee State University
Other Identifiers
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0000001
Identifier Type: -
Identifier Source: org_study_id