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OpenTrials
Completed

NCT Number: NCT02488785

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

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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Doctors Hospital at Renaissance

Edinburg, Texas, 78539, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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.

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.

Other names: physical activity tracker

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

Primary outcomes

  1. Hemoglobin A1c

    Time frame: 9 months

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

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • DHR Health Institute for Research and Development
  • Verizon Foundation

Registry information

Official study title

The Impact of a Comprehensive Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With Type 2 Diabetes

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 2, 2015
Registry last updated
Sep 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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