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

NCT ID: NCT05893927

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Diabetes Education Lifestyle Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Participants will be recruited to participate in the study, and then randomized to one of two arms.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Diabetes education web site application

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reading Hospital Foundation

UNKNOWN

Sponsor Role collaborator

Complete Statistical Services (Consult-Stat)

UNKNOWN

Sponsor Role collaborator

The Reading Hospital and Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Luis Murillo

Residency Faculty Associate, Director Hanna Center for Primary Care Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luis A Murillo, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Reading Hospital Tower Health

Locations

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Reading Hospital, an affiliate of Tower Health

West Reading, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mary E Alderfer, MSN

Role: CONTACT

484-628-8360

Pamela Marrero

Role: CONTACT

484-628-8355

Facility Contacts

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Research coordinator

Role: primary

484-628-8585

References

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Shan R, Sarkar S, Martin SS. Digital health technology and mobile devices for the management of diabetes mellitus: state of the art. Diabetologia. 2019 Jun;62(6):877-887. doi: 10.1007/s00125-019-4864-7. Epub 2019 Apr 8.

Reference Type BACKGROUND
PMID: 30963188 (View on PubMed)

Ball E, Rivas C. Health Apps Require Co-development to Be Acceptable and Effective. Front Psychol. 2021 Jul 16;12:714453. doi: 10.3389/fpsyg.2021.714453. eCollection 2021. No abstract available.

Reference Type BACKGROUND
PMID: 34335428 (View on PubMed)

Kao CK, Liebovitz DM. Consumer Mobile Health Apps: Current State, Barriers, and Future Directions. PM R. 2017 May;9(5S):S106-S115. doi: 10.1016/j.pmrj.2017.02.018.

Reference Type BACKGROUND
PMID: 28527495 (View on PubMed)

Doyle-Delgado K, Chamberlain JJ. Use of Diabetes-Related Applications and Digital Health Tools by People With Diabetes and Their Health Care Providers. Clin Diabetes. 2020 Dec;38(5):449-461. doi: 10.2337/cd20-0046.

Reference Type BACKGROUND
PMID: 33384470 (View on PubMed)

Ye Q, Khan U, Boren SA, Simoes EJ, Kim MS. An Analysis of Diabetes Mobile Applications Features Compared to AADE7: Addressing Self-Management Behaviors in People With Diabetes. J Diabetes Sci Technol. 2018 Jul;12(4):808-816. doi: 10.1177/1932296818754907. Epub 2018 Feb 1.

Reference Type BACKGROUND
PMID: 29390917 (View on PubMed)

Bonoto BC, de Araujo VE, Godoi IP, de Lemos LL, Godman B, Bennie M, Diniz LM, Junior AA. Efficacy of Mobile Apps to Support the Care of Patients With Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. JMIR Mhealth Uhealth. 2017 Mar 1;5(3):e4. doi: 10.2196/mhealth.6309.

Reference Type BACKGROUND
PMID: 28249834 (View on PubMed)

American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S73-S84. doi: 10.2337/dc21-S006.

Reference Type BACKGROUND
PMID: 33298417 (View on PubMed)

Cui M, Wu X, Mao J, Wang X, Nie M. T2DM Self-Management via Smartphone Applications: A Systematic Review and Meta-Analysis. PLoS One. 2016 Nov 18;11(11):e0166718. doi: 10.1371/journal.pone.0166718. eCollection 2016.

Reference Type BACKGROUND
PMID: 27861583 (View on PubMed)

He Q, Zhao X, Wang Y, Xie Q, Cheng L. Effectiveness of smartphone application-based self-management interventions in patients with type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials. J Adv Nurs. 2022 Feb;78(2):348-362. doi: 10.1111/jan.14993. Epub 2021 Jul 29.

Reference Type BACKGROUND
PMID: 34324218 (View on PubMed)

Jeste DV, Palmer BW, Appelbaum PS, Golshan S, Glorioso D, Dunn LB, Kim K, Meeks T, Kraemer HC. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007 Aug;64(8):966-74. doi: 10.1001/archpsyc.64.8.966.

Reference Type BACKGROUND
PMID: 17679641 (View on PubMed)

Beckerle CM, Lavin MA. Association of Self-Efficacy and Self-Care With Glycemic Control in Diabetes. Diabetes Spectrum. 2013; 26(3): 172-178

Reference Type BACKGROUND

Related Links

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https://www.pewresearch.org/internet/fact-sheet/mobile/

Mobile Fact Sheet from Pew Research Center, published April 07, 2021

Other Identifiers

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2023-020

Identifier Type: -

Identifier Source: org_study_id

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