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

July 25, 2025 updated by: Luis Murillo, The Reading Hospital and Medical Center

Evaluating the Clinical Impact of a PCP Developed Diabetes Education Mobile Web Application on Patients With Uncontrolled Type 2 Diabetes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • West Reading, Pennsylvania, United States, 19611
        • Recruiting
        • Reading Hospital, an affiliate of Tower Health
        • Contact:
        • Principal Investigator:
          • Luis A Murillo, MD, MPH
        • Sub-Investigator:
          • Sally Snyder, MSN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
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.
Other: Diabetes education web site application
The Diabetes education website application will contain informational videos for this protocol. The videos will include a welcome video and the categorical topics of Healthy Coping, Healthy Eating, Staying Active, Medications (Use and Safety), Problem Solving in Diabetes, and Disease Pathophysiology. Each category contains several videos providing education about a different component of diabetes care.
No Intervention: Control arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: 6 months
Blood Test
6 months
"Self-Efficacy for Diabetes Scale"
Time Frame: 6 months
A validated (free to use) survey that examines self-perceived ability to manage diabetes. Scores are reported on a scale from 1-10. 1 reflecting Not at all confident and 10 reflecting confident. The minimum total value is 8, and the maximum value is 80. A higher score indicates that the individual has a better outcome, i.e., more confident that he/she can perform the task regularly at the present time.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index
Time Frame: 6 months
Height-to-weight ratio, an indicator of underweight, normal weight, or overweight/obese
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Reading Hospital and Medical Center

Collaborators

Reading Hospital Foundation
Complete Statistical Services (Consult-Stat)

Investigators

  • Principal Investigator: Luis A Murillo, MD, MPH, Reading Hospital Tower Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 25, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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