T2DXcel Mobile Application

NCT03890900 | Completed Phase 1

• 1 other identifier: 2018-9590
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change from baseline hemoglobin A1c to 3 and 6 months

  Patients' glycemic control measured by hemoglobin A1c

  Baseline, 3 months, 6 months

Secondary Outcomes (6)

• 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

  Baseline, 3 months, 6 months

• Change from baseline diabetes self-management capabilities to 3 months and 6 months

  Baseline, 3 months, 6 months

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

  Baseline, 3 months, 6 months

• Change from baseline diabetes quality of life to 3 months and 6 months

  Baseline, 3 months, 6 months

Study Arms (1)

T2DXcel mobile application

OTHER

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

Other: T2DXcel mobile application

Interventions

T2DXcel mobile application OTHER

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

T2DXcel mobile application

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Sunit Jariwala, MD

  Albert Einstein College of Medicine and Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Medicine)

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2019
• First Posted: March 26, 2019
• Study Start: March 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)