T2DXcel Mobile Application (T2DXcel)

Developing and Evaluating the T2DXcel Mobile Application for Adult Patients With Type 2 Diabetes

Given the need for personalizable and adaptive mobile applications for patients with type 2 diabetes, this proposal will develop, evaluate, and refine a patient-centered mobile application (T2DXcel), which will deliver tailored and algorithm-based diabetes education to improve process and diabetes-related outcomes.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: T2DXcel mobile application

Detailed Description

The Bronx has the heaviest burden of diabetes within New York City (NYC) and statewide. The highest diabetes hospitalization and death rates in NYC occur in the Bronx, which has hospitalization rates approximately 25 percent above the statewide average. The Bronx is one of the poorest urban counties in the nation, and diabetes disproportionately impacts high-poverty communities. The borough has an ethnically and racially diverse population (53.5% of residents are Hispanic and 36.5% are black), and diabetes is highly prevalent among blacks and Hispanics. Obesity, a major risk factor for diabetes, is also prevalent with nearly 33% (much higher than the 24% prevalence of obesity in NYC) of Bronx adults being obese. Among the many social determinants of health, medical provider practice behaviors, suboptimal access to health care, lack of patient knowledge regarding proper medication administration and potential side effects, and difficulty adhering to medical regimens by patients and families all contribute to poor diabetes outcomes.

With appropriate medical care including education (especially regarding potentially modifiable lifestyle factors that contribute to diabetes), well-informed patients can achieve diabetes control. However, there are significant challenges in providing effective patient education in the ambulatory setting, such as time constraints and prioritizing other issues (e.g. comorbid conditions) above comprehensive diabetes education. While patient education and teaching self-management skills are critical to improve diabetes outcomes, such strategies will succeed only as part of more comprehensive interventions. Diabetes self-management education (DSME) has been linked to decreases in hemoglobin A1c, reductions in the onset and/or progression of diabetes complications, reductions in diabetes-related hospitalizations and readmissions, and improvements in quality of life, lifestyle behaviors (e.g. physical activity, healthier eating), self-efficacy, and coping skills. The American Association of Diabetes Educators (AADE) has described the AADE7 Self-Care Behaviors (healthy eating, being active, monitoring, taking medications, problem solving, healthy coping, reducing risks) as a framework to organize and structure patient-centered education. Despite the proven benefits of DSME, less than 10% of type 2 diabetes (T2D) patients receive structured education for a variety of reasons: providers' misunderstanding of DSME effectiveness and confusion about how to make referrals; many clinic sites' lack of access to DSME services; and some payers' lack of coverage for DSME services. With the increasing use of smartphones and the internet, health information technology (IT)-based approaches (e.g. mobile applications, text messaging platforms, internet-based educational modules, and telemedicine/telehealth interventions) - through standalone interventions or by supplementing education (i.e. by reinforcing content delivered in-person) - can increase patients' access to DSME, and have been linked to improvements in hemoglobin A1c and other outcomes. Mobile applications ('apps') can provide day-to-day support for patients with diabetes, but commonly lack evidence-based content and/or comprehensiveness. A recent study reported that only a small percentage of the diabetes apps available on the iOS and Android stores supported the AADE7 behaviors regarding problem solving, healthy coping, and reducing risks. Another recent article suggested that few apps provided personalized education or tailored therapeutic support. As with other chronic conditions, diabetes mobile applications are often characterized by low retention rates and decreased user engagement with the app following the initial download.

Given the need for personalizable and adaptive mobile applications for patients with type 2 diabetes, this proposal will develop, evaluate, and refine a patient-centered mobile application (T2DXcel), which will deliver tailored and algorithm-based diabetes education to improve process and diabetes-related outcomes.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

English-speaking individuals >18 years with:

1. T2D (diagnosis made by a healthcare provider) on an anti-diabetic medication with hemoglobin A1c > 6.5% at the time of recruitment and enrollment
2. Diabetes care at Montefiore
3. Able to give informed consent; and d) smartphone (iOS or Android) access

Exclusion Criteria:

1. Pregnancy
2. Chronic illness with organ failure (heart failure, severe liver disease, chronic kidney disease stage 3-4 or dialysis) or requiring chemotherapy or steroid use
3. Severe psychiatric or cognitive problems that would prohibit an individual from completing the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: T2DXcel mobile application; T2DXcel is a mobile application (patient-facing) that delivers guideline-based diabetes education.	Other: T2DXcel mobile application; T2DXcel is a mobile application (patient-facing) that delivers guideline-based diabetes education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline hemoglobin A1c to 3 and 6 months	Patients' glycemic control measured by hemoglobin A1c	Baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction measured by the Client Satisfaction Questionnaire-8	Patient satisfaction measured by the Client Satisfaction Questionnaire-8	Baseline, 3 months, 6 months
Change from baseline diabetes knowledge to 3 months and 6 months	Diabetes knowledge as measured by the validated Diabetes Knowledge Questionnaire-24	Baseline, 3 months, 6 months
Change from baseline diabetes self-management capabilities to 3 months and 6 months	Diabetes self-management capabilities as measured by the Diabetes Self-Management Questionnaire	Baseline, 3 months, 6 months
Change from baseline diabetes self-efficacy to 3 months and 6 months	Diabetes self-efficacy as measured by the Diabetes Empowerment Scale-Short Form	Baseline, 3 months, 6 months
Change from baseline diabetes quality of life to 3 months and 6 months	Patients' diabetes quality of life measured by the Diabetes Quality of Life questionnaire	Baseline, 3 months, 6 months
Change from baseline LDL cholesterol to 3 months and 6 months	LDL cholesterol	Baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Sunit Jariwala, MD, Albert Einstein College of Medicine and Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: March 23, 2019
• First Submitted That Met QC Criteria: March 23, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2018-9590

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only aggregated and de-identified datasets will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No