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

NCT05893927 | Recruiting

• 1 other identifier: 2023-020
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Hemoglobin A1c

  Blood Test

  6 months

• "Self-Efficacy for Diabetes Scale"

  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 Outcomes (1)

• Body Mass Index

  6 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Control arm

NO 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.

Interventions

Diabetes education web site application 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.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Reading Hospital and Medical Center: lead
• Reading Hospital Foundation: collaborator
• Complete Statistical Services (Consult-Stat): collaborator

Study Sites (1)

Reading Hospital, an affiliate of Tower Health

West Reading, Pennsylvania, 19611, United States

RECRUITING

Related Publications (11)

• 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.

  PMID: 30963188 BACKGROUND

• 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.

  PMID: 34335428 BACKGROUND

• 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.

  PMID: 28527495 BACKGROUND

• 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.

  PMID: 33384470 BACKGROUND

• 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.

  PMID: 29390917 BACKGROUND

• 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.

  PMID: 28249834 BACKGROUND

• 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.

  PMID: 33298417 BACKGROUND

• 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.

  PMID: 27861583 BACKGROUND

• 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.

  PMID: 34324218 BACKGROUND

• 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.

  PMID: 17679641 BACKGROUND

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

  BACKGROUND

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Luis A Murillo, MD, MPH

  Reading Hospital Tower Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary E Alderfer, MSN

CONTACT

484-628-8360; mary.alderfer@towerhealth.org

Pamela Marrero

CONTACT

484-628-8355; pamela.marrero@towerhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residency Faculty Associate, Director Hanna Center for Primary Care Research

Model Details: Participants will be recruited to participate in the study, and then randomized to one of two arms.

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: February 15, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)