T2DXcel Mobile Application



Status:Not yet recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:3/28/2019
Start Date:July 1, 2019
End Date:June 30, 2020
Contact:Sunit Jariwala, MD
Email:sjariwal@montefiore.org
Phone:8666338255

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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.

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.

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
We found this trial at
1
site
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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mi
from
Bronx, NY
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