Evaluating a Digital Diabetes Education Program

NCT04198935 | Unknown

• 1 other identifier: 0000001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (6)

• Change in weight

  Change from baseline weight in kilograms at 3 months

  3 months

• Blood pressure

  Change from baseline systolic blood pressure in millimeters of mercury (mmHg) at 3 months

  3 months

• Hemoglobin A1C (HbA1C) level

  Change from baseline HbA1C level in mmol/mol at 3 months

  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

  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

  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.

  3 months

Study Arms (1)

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.

Device: Span Health Mobile Application

Interventions

Span Health Mobile Application DEVICE

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adam Bataineh: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Adam Bataineh, MD MSc

  Span Health, East Suffolk and North Essex NHS Foundation Trust

  STUDY DIRECTOR

• Sumbal Babar, MBBS

  East Tennessee State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Medical Officer

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: December 13, 2019
• Study Start: May 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2020
• Last Updated: December 23, 2019

Record last verified: 2019-12