Impact of a Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With T2 Diabetes

NCT02488785 | Completed Results

• 1 other identifier: 2014-42
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the impact of a comprehensive diabetes education and management program based on frequent communication with patients using teleconsultation, text messaging, and phone calls on diabetes related outcomes in Latino patients with type 2 diabetes. The investigators hypothesize that the decline in hemoglobin A1c value between the baseline and the six-month visit will be at least 0.5 percent greater in the intervention group than in the control group.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; Telehealth; Hispanics; Latinos; Self-Care; Mobile Health; mHealth

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

  The A1C test is a blood test used to diagnose type 2 diabetes and then to manage diabetes. It is measured as a percent.

  9 months

Study Arms (2)

Control

NO INTERVENTION

Patients in this group will attend regular clinical and education appointments as offered by the clinic for their diabetes care.

Intervention

EXPERIMENTAL

Patients in this group will be part of a Virtual Diabetes Self-Care and Education Program. They will receive a phone to communicate with a diabetes educator for 6 months. They will connect with the diabetes educator for weekly video conferences of up to 30 minutes for twelve consecutive weeks, followed by 7 phone calls. Additionally, they will receive a weekly text message about diabetes for 6 months.

Behavioral: Virtual Diabetes Self-Care and Education Program; Device: Fitbit; Device: Smartphone

Interventions

Virtual Diabetes Self-Care and Education Program BEHAVIORAL

Participants will be able to have frequent contact in order to share physical activity and glucose data with the diabetes educator using the smartphone they will receive. Information downloaded to the Glooko Population Management tool can be shared with the diabetes educator.

Intervention

Fitbit DEVICE

Participants will be given a Fitbit physical activity tracker which they can use to record their activity and share the information with the diabetes educator using the device's smartphone application.

Also known as: physical activity tracker

Intervention

Smartphone DEVICE

All virtual visits were performed via provided smartphone. In addition, participants will receive a Glooko MeterSync Blue cable which is able to connect to most glucose meters in order to download glucose data to the Glooko Population Management tool on their smartphones

Intervention

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have physician-diagnosed type 2 diabetes
• Be self-identified as Hispanic or Latino
• An A1c value between 8-14% within the last three months.
• Demonstrate the ability, either alone or with the help of a family member that will be with the patient at least once a week, to use the technology that will be used during the teleconsultations

You may not qualify if:

• Severe diabetes related chronic complications such as chronic renal failure, blindness, amputations, stroke, etc.
• Concomitant chronic illnesses that would affect their participation in the program, i.e. cancer, debilitating diseases, etc.
• Any other condition that would affect participant's basic mental health skills
• Type 1 diabetes or gestational diabetes
• Patients with abnormal hemoglobin, anemia or any condition that may affect red blood cell turnover. Any of these conditions may be detected through participants' history or through the laboratory report at study screening
• Signs or symptoms of metabolic decompensation (polyuria, polydypsia, polyphagia, unexplained weight loss, blurry vision, lethargy, etc.)

Sponsors & Collaborators

• Joslin Diabetes Center: lead
• Verizon Foundation: collaborator
• DHR Health Institute for Research and Development: collaborator

Study Sites (1)

Doctors Hospital at Renaissance

Edinburg, Texas, 78539, 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

Results Point of Contact

• Title: Sylvia Rosas
• Organization: Joslin Diabetes Center

sylvia.rosas@joslin.harvard.edu

6173092486

Study Officials

• Sylvia E Rosas, MD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

• Marcel Twahirwa, MD

  Doctors Hospital at Reinassance

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: July 2, 2015
• Study Start: June 1, 2015
• Primary Completion: March 31, 2017
• Study Completion: November 30, 2017
• Last Updated: September 6, 2022
• Results First Posted: September 6, 2022

Record last verified: 2022-08

Locations

US (1)