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Diabetes Mellitus, Type 2Phase 1/2T2DXcelNCT03890900

T2DXcel Mobile Application

A Phase 1/2 study testing T2DXcel mobile application in people with Diabetes Mellitus, Type 2, run by Montefiore Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
T2DXcel mobile application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
1 Mar 2020to 1 Jul 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
T2DXcel mobile application
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • T2DXcel mobile applicationOther

    T2DXcel is a mobile application (patient-facing) that delivers guideline-based diabetes education.

Study groups in NCT03890900
Study groupRoleWhat they receive
T2DXcel mobile applicationOtherT2DXcel is a mobile application (patient-facing) that delivers guideline-based diabetes education.
Receives: Other: T2DXcel mobile application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline hemoglobin A1c to 3 and 6 months

    Patients' glycemic control measured by hemoglobin A1c

    Measured: Baseline, 3 months, 6 months

Secondary outcomes (6)
  1. Patient satisfaction measured by the Client Satisfaction Questionnaire-8

    Patient satisfaction measured by the Client Satisfaction Questionnaire-8

    Measured: Baseline, 3 months, 6 months

  2. Change from baseline diabetes knowledge to 3 months and 6 months

    Diabetes knowledge as measured by the validated Diabetes Knowledge Questionnaire-24

    Measured: Baseline, 3 months, 6 months

  3. 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

    Measured: Baseline, 3 months, 6 months

  4. Change from baseline diabetes self-efficacy to 3 months and 6 months

    Diabetes self-efficacy as measured by the Diabetes Empowerment Scale-Short Form

    Measured: Baseline, 3 months, 6 months

  5. 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

    Measured: Baseline, 3 months, 6 months

  6. Change from baseline LDL cholesterol to 3 months and 6 months

    LDL cholesterol

    Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2019
  2. Study start1 Mar 2020
  3. Primary completion1 Jul 2022
  4. Study completion1 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03890900
Sponsor's protocol ID
2018-9590
Acronym
T2DXcel
Status last verified
Aug 2022
First submitted
23 Mar 2019
Last updated
18 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only aggregated and de-identified datasets will be shared with other researchers.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing T2DXcel mobile application in people with Diabetes Mellitus, Type 2, run by Montefiore Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline hemoglobin A1c to 3 and 6 months (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022; AzTrials last refreshed its copy on 3 Nov 2026.

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