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

Joslin Diabetes Center

Status: Completed

Conditions: Type 2 Diabetes Mellitus

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02488785

2014-42

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Control

No Intervention group

Description:

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

Intervention

Experimental group

Description:

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.

Treatment:

Device: Smartphone

Behavioral: Virtual Diabetes Self-Care and Education Program

Device: Fitbit