Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Type 2 diabetes is a long-term illness that causes blood sugar levels to rise. Diabetes causes many health problems and can be hard to manage. More than half of Hispanics in the United States will develop type 2 diabetes in their lifetime.

Usual care for diabetes includes doctor visits, monitoring of blood glucose, screening for other health problems, and medicine. Patients may also have access to a diabetes educator.

In this study, the research team is comparing two ways to help Hispanic patients with diabetes manage their illness. One way is usual diabetes care provided during doctor office visits plus diabetes telemanagement, or DTM. DTM allows patients to track vital signs, such as pulse and blood pressure, and communicate with their clinician, such as a doctor or nurse practitioner, through their smart phone, tablet, or other smart device. The other way is usual diabetes care alone.  

Who can this research help?

Results may help doctors when considering ways to help Hispanic patients manage type 2 diabetes.

What is the research team doing?

This study has two parts. In the first part, the research team is working with patients, caregivers, community leaders, and the American Diabetes Association to adapt a DTM program for Hispanic patients.

In the second part, the research team is enrolling 240 Hispanic patients with type 2 diabetes from the New York City area. The team is assigning patients by chance to take part in the adapted DTM program in addition to their usual diabetes care or receive usual care alone. Doctors teach patients how to check their blood sugar. Patients have routine visits every three months and can consult a diabetes educator.

Patients in the DTM program and their caregivers receive tablets that connect them to a clinician. The DTM program also includes

  • Weekly real-time virtual visits between the patient and a certified diabetes care and education nurse
  • Vital signs monitoring
  • Blood sugar monitoring
  • Reminders to take medicines
  • Educational videos and quizzes for patients on ways to manage diabetes
  • An app caregivers can use to interact with and remind the patient to follow his or her care plan

Over a period of six months, a nurse from the research team follows up with patients to ask about

  • Healthcare use
  • Diabetes symptoms
  • Confidence in diabetes self-care
  • Quality of life
  • Distress related to diabetes
  • Sick days from work 

The research team is looking at patients’ medical records to collect data on weight, cholesterol, blood pressure, and diabetes control.

Hispanic people with diabetes are helping to plan and conduct the study.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population 240 Hispanic adults diagnosed with type 2 diabetes
Interventions/
Comparators
  • Usual diabetes care plus DTM
  • Usual diabetes care alone
Outcomes

Primary: HbA1c at 6 months

Secondary: HbA1c at 12 months, hypoglycemic episodes, adherence, diabetes self-efficacy, problem areas in diabetes, weight, cholesterol, blood pressure, diabetes quality of life, diabetes distress, inpatient utilization, unscheduled type 2 diabetes physician visits..

Timeframe 6-month follow-up for primary outcome

Project Information

Renee Pekmezaris, PhD
Feinstein Institute for Medical Research
$2,973,996

Key Dates

36 months
August 2018
December 2023
2018

Study Registration Information

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PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders.

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PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care.

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Last updated: September 17, 2021