T2DXcel Mobile Application (T2DXcel)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
T2DXcel mobile application
Sponsored by

About this trial
This is an interventional health services research trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
English-speaking individuals >18 years with:
- T2D (diagnosis made by a healthcare provider) on an anti-diabetic medication with hemoglobin A1c > 6.5% at the time of recruitment and enrollment
- Diabetes care at Montefiore
- Able to give informed consent; and d) smartphone (iOS or Android) access
Exclusion Criteria:
- Pregnancy
- Chronic illness with organ failure (heart failure, severe liver disease, chronic kidney disease stage 3-4 or dialysis) or requiring chemotherapy or steroid use
- Severe psychiatric or cognitive problems that would prohibit an individual from completing the protocol
Sites / Locations
- Montefiore Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
T2DXcel mobile application
Arm Description
T2DXcel is a mobile application (patient-facing) that delivers guideline-based diabetes education.
Outcomes
Primary Outcome Measures
Change from baseline hemoglobin A1c to 3 and 6 months
Patients' glycemic control measured by hemoglobin A1c
Secondary Outcome Measures
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Change from baseline diabetes knowledge to 3 months and 6 months
Diabetes knowledge as measured by the validated Diabetes Knowledge Questionnaire-24
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
Change from baseline diabetes self-efficacy to 3 months and 6 months
Diabetes self-efficacy as measured by the Diabetes Empowerment Scale-Short Form
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
Change from baseline LDL cholesterol to 3 months and 6 months
LDL cholesterol
Full Information
NCT ID
NCT03890900
First Posted
March 23, 2019
Last Updated
August 17, 2022
Sponsor
Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03890900
Brief Title
T2DXcel Mobile Application
Acronym
T2DXcel
Official Title
Developing and Evaluating the T2DXcel Mobile Application for Adult Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
This proposal will develop, evaluate, and refine a patient-centered mobile application (DiabetesXcel), which will deliver tailored and algorithm-based diabetes education to improve the process and diabetes-related outcomes. We also test the reliability of eHEALS and NVS questionnaires.
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T2DXcel mobile application
Arm Type
Other
Arm Description
T2DXcel is a mobile application (patient-facing) that delivers guideline-based diabetes education.
Intervention Type
Other
Intervention Name(s)
T2DXcel mobile application
Intervention Description
T2DXcel is a mobile application (patient-facing) that delivers guideline-based diabetes education.
Primary Outcome Measure Information:
Title
Change from baseline hemoglobin A1c to 3 and 6 months
Description
Patients' glycemic control measured by hemoglobin A1c
Time Frame
Baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Description
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Time Frame
Baseline, 3 months, 6 months
Title
Change from baseline diabetes knowledge to 3 months and 6 months
Description
Diabetes knowledge as measured by the validated Diabetes Knowledge Questionnaire-24
Time Frame
Baseline, 3 months, 6 months
Title
Change from baseline diabetes self-management capabilities to 3 months and 6 months
Description
Diabetes self-management capabilities as measured by the Diabetes Self-Management Questionnaire
Time Frame
Baseline, 3 months, 6 months
Title
Change from baseline diabetes self-efficacy to 3 months and 6 months
Description
Diabetes self-efficacy as measured by the Diabetes Empowerment Scale-Short Form
Time Frame
Baseline, 3 months, 6 months
Title
Change from baseline diabetes quality of life to 3 months and 6 months
Description
Patients' diabetes quality of life measured by the Diabetes Quality of Life questionnaire
Time Frame
Baseline, 3 months, 6 months
Title
Change from baseline LDL cholesterol to 3 months and 6 months
Description
LDL cholesterol
Time Frame
Baseline, 3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
English-speaking individuals >18 years with:
T2D (diagnosis made by a healthcare provider) on an anti-diabetic medication with hemoglobin A1c > 6.5% at the time of recruitment and enrollment
Diabetes care at Montefiore
Able to give informed consent; and d) smartphone (iOS or Android) access
Exclusion Criteria:
Pregnancy
Chronic illness with organ failure (heart failure, severe liver disease, chronic kidney disease stage 3-4 or dialysis) or requiring chemotherapy or steroid use
Severe psychiatric or cognitive problems that would prohibit an individual from completing the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunit Jariwala, MD
Organizational Affiliation
Albert Einstein College of Medicine and Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only aggregated and de-identified datasets will be shared with other researchers.
Learn more about this trial
T2DXcel Mobile Application
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