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

NCT ID: NCT02488785

Last Updated: 2022-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-11-30

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.

Detailed Description

In this study participants will be followed for a period of 9 months. The control group will receive usual care during this period of time. While, the intervention group will be part of a diabetes education and management program lasting 6 months via a smartphone participants will receive. The 6 month intervention will be followed by a 3 month observation period.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

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.

Group Type: EXPERIMENTAL

Virtual Diabetes Self-Care and Education Program

Intervention Type: 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.

Fitbit

Intervention Type: 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.

Smartphone

Intervention Type: 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

Interventions

Virtual Diabetes Self-Care and Education Program

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 Type: BEHAVIORAL

Fitbit

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.

Intervention Type: DEVICE

Smartphone

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 Type: DEVICE

Other Intervention Names

physical activity tracker

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Verizon Foundation

OTHER

Sponsor Role: collaborator

DHR Health Institute for Research and Development

OTHER

Sponsor Role: collaborator

Joslin Diabetes Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvia E Rosas, MD

Role: PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center

Marcel Twahirwa, MD

Role: PRINCIPAL_INVESTIGATOR

Doctors Hospital at Reinassance

Locations

Doctors Hospital at Renaissance

Edinburg, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2014-42

Identifier Type: -

Identifier Source: org_study_id