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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488785
• Other study ID #: 2014-42
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: November 30, 2017

Study information

• Verified date: August 2022
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: November 30, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• 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.

Device:
• 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.
• 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

Locations

Country	Name	City	State
United States	Doctors Hospital at Renaissance	Edinburg	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Joslin Diabetes Center	DHR Health Institute for Research and Development, Verizon Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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