Impact of a Diabetes Education Mobile Web Application on Patients With Uncontrolled Type 2 Diabetes

The Reading Hospital and Medical Center

Status: Enrolling

Conditions: Lifestyle Modification; Diabetes Education; Diabetes Mellitus, Type 2

Treatments: Other: Diabetes education web site application

Study type: Interventional

Funder types: Other

Identifiers

NCT05893927

2023-020

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the use and effectiveness of a mobile web application (app) that is designed to educate and allow patients to manage diabetes and make sustainable lifestyle changes, and to study the impact of the app on clinical outcomes of diabetes (HA1C) and educational outcomes (Self-Efficacy for Diabetes Scale). The main question to answer is: Does the use of the Diabetes Application significantly affect clinical outcomes of diabetes and cardiometabolic risk factors (BMI and Blood Pressure)? Patients will be enrolled in one of two available arms of the study.

Participants in the 'intervention arm' will use the app to view educational information presented as videos in the following areas: Healthy Coping, Healthy Eating, Staying Active, Medications (Use and Safety), Problem Solving in Diabetes and Disease Pathophysiology. They will continue routine follow-up care with their primary care physicians during the study.

Participants in the 'control arm' will continue with their primary care physician in routine follow-up care, as normally scheduled.

Researchers will compare the intervention arm participants to the control arm participants to find out about and compare changes in HA1C, systolic blood pressure, diastolic blood pressure, and body mass index. Groups will also be compared on the basis of self-perceived confidence of managing their diabetes by way of the Diabetes Self Efficacy Scale.

Enrollment: 65 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Diagnosis of Type 2 Diabetes with HA1c >8.0
• Current patients of the Family Healthcare Center, Reading Hospital Tower health.

Exclusion criteria

• Identified special populations (pregnancy or individuals currently incarcerated)
• Patients without access to their own smart phone
• Any patient who is unable to provide their own informed consent to participate in the study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

65 participants in 2 patient groups

Intervention arm

Experimental group

Description:

Participants enrolled in the intervention arm will be given a 6-month access period to the diabetes education application designed by the study team. The web site will offer videos related to a specific areas of education concerning diabetes self-management. To encourage compliance, participant users will receive weekly notifications from the application that will guide them through viewing all videos in the series. Participants will continue routine follow-up appointments with their primary care physicians during the study period. There will be no restrictions on starting or stopping medications during the study period.

Treatment:

Other: Diabetes education web site application

Control arm

No Intervention group

Description:

Participants in the control arm will not have access to the Diabetes Application. They will continue follow-up appointments according to the standard of care with their primary care physician, diabetic educators, etc. There are no restrictions on starting or stopping medications for patients within the control arm.