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Evaluating a Digital Diabetes Education Program

20 grudnia 2019 zaktualizowane przez: Adam Bataineh

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.

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.

Przegląd badań

Status

Nieznany

Warunki

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

100

Faza

  • Nie dotyczy

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Diagnosed with type 2 diabetes
  • Have access to and feel comfortable using a smart phone

Exclusion Criteria:

  • 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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in weight
Ramy czasowe: 3 months
Change from baseline weight in kilograms at 3 months
3 months
Blood pressure
Ramy czasowe: 3 months
Change from baseline systolic blood pressure in millimeters of mercury (mmHg) at 3 months
3 months
Hemoglobin A1C (HbA1C) level
Ramy czasowe: 3 months
Change from baseline HbA1C level in mmol/mol at 3 months
3 months
Lipid profile
Ramy czasowe: 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
3 months
Participant's experience
Ramy czasowe: 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
3 months
Adherence to the the program
Ramy czasowe: 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.
3 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Dyrektor Studium: Adam Bataineh, MD MSc, Span Health, East Suffolk and North Essex NHS Foundation Trust
  • Główny śledczy: Sumbal Babar, MBBS, East Tennessee State University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Oczekiwany)

1 maja 2020

Zakończenie podstawowe (Oczekiwany)

1 lipca 2020

Ukończenie studiów (Oczekiwany)

1 sierpnia 2020

Daty rejestracji na studia

Pierwszy przesłany

22 listopada 2019

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 grudnia 2019

Pierwszy wysłany (Rzeczywisty)

13 grudnia 2019

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 grudnia 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 grudnia 2019

Ostatnia weryfikacja

1 grudnia 2019

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 0000001

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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