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Clinical Trials/NCT02488785
NCT02488785
Completed
Not Applicable

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

Joslin Diabetes Center1 site in 1 country96 target enrollmentJune 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
Joslin Diabetes Center
Enrollment
96
Locations
1
Primary Endpoint
Hemoglobin A1c
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
November 30, 2017
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.)

Outcomes

Primary Outcomes

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.

Study Sites (1)

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