Recruiting

Diabetes Education

Sponsor:

The Reading Hospital and Medical Center

Code:

NCT05893927

Conditions

Diabetes Mellitus, Type 2

Diabetes Education

Lifestyle Modification

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diabetes education web site application

Study Details

Brief summary:

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.

Conditions

Diabetes Mellitus, Type 2

Diabetes Education

Lifestyle Modification

Study ID

NCT05893927

Start date

Feb 15, 2024

Status verified date

Jul, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

65 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Hemoglobin A1c [ Time Frame: 6 months ]
  • "Self-Efficacy for Diabetes Scale" [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

Reading Hospital, an affiliate of Tower Health

Recruiting

West Reading, Pennsylvania, United States, 19611

Contacts

Principal Investigator:

Luis A Murillo, MD, MPH

More Information

Sponsor

The Reading Hospital and Medical Center

Last update posted

Jul 30, 2025

Last verified

Jul, 2025

Keywords

  • Type 2 diabetes
  • Type II diabetes
  • uncontrolled type 2 diabetes
  • hyperglycemia
  • mobile web application
  • Diabetes education

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Reading Hospital and Medical Center on 2025-07-30.