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Behavioural Intervention

Diabetes Education App for Type 2 Diabetes

N/A

Recruiting

Led By Luis A Murillo, MD, MPH

Research Sponsored by The Reading Hospital and Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Type 2 Diabetes with HA1c >8.0

Age ≥ 18 years

Must not have

Any patient who is unable to provide their own informed consent to participate in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how an app can help people with diabetes manage their condition better & improve health outcomes.

Who is the study for?

This trial is for adults over 18 with uncontrolled Type 2 Diabetes (HA1c >8.0) who are patients at the Family Healthcare Center, Reading Hospital Tower Health. It's not for pregnant individuals, incarcerated people, those without a smartphone, or anyone unable to consent.

What is being tested?

The study tests a diabetes education app that provides videos on managing diabetes and lifestyle changes versus usual care without the app. The impact on blood sugar control (HA1C), body weight, blood pressure, and self-management confidence is measured.

What are the potential side effects?

Since this intervention involves educational content rather than medication or invasive procedures, no direct medical side effects are expected from using the mobile web application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Type 2 Diabetes with an HA1c level above 8.0.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am able to give my own consent to participate in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

"Self-Efficacy for Diabetes Scale"

Hemoglobin A1c

Secondary study objectives

Blood pressure

Body Mass Index

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention armExperimental Treatment1 Intervention

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.

Group II: Control armActive Control1 Intervention

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.

0 / 3Eligibility criteria met