Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, Telehealth, Hispanics, Latinos, Self-Care, Mobile Health, mHealth
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.
Interventions
BEHAVIORALVirtual 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.
DEVICEFitbit
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.
DEVICESmartphone
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
Sponsors
Verizon Foundation
DHR Health Institute for Research and Development
Joslin Diabetes Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Patients in this group will attend regular clinical and education appointments as offered by the clinic for their diabetes care. | 47 |
| Intervention Patients (pt) in this group will be part of a Virtual Diabetes Self-Care and Education (DSME) Program. Pt will receive a phone to connect with a diabetes educator (DE) for 6 months. Pt will have a weekly video call of up to 30 min. with the DE for 12 weeks, followed by 7 phone calls. Pt will get a weekly text message about diabetes for 6 months.
Virtual DSME Program: pt will have frequent contact in order to share physical activity and glucose data with the DE using smartphone. Information downloaded to the Glooko can be shared with the DE.
Fitbit: Participants will be given a Fitbit physical activity tracker which they can use to record their activity and share the information with the DE using the device's smartphone application.
Smartphone: All virtual visits were performed via. In addition, pt will receive a Glooko MeterSync which is able to connect to most glucose meters in order to download glucose data to the Glooko Population Management tool on their smartphones | 49 |
| Total | 96 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| Age, Continuous | 50.9 years STANDARD_DEVIATION 11.8 | 54.2 years STANDARD_DEVIATION 11.6 | 57.6 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 49 Participants | 96 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hemoglobin A1C | 9.97 % STANDARD_DEVIATION 1.78 | 9.7 % STANDARD_DEVIATION 1.5 | 9.56 % STANDARD_DEVIATION 1.3 |
| Region of Enrollment United States | 49 Participants | 96 Participants | 47 Participants |
| Sex: Female, Male Female | 29 Participants | 61 Participants | 32 Participants |
| Sex: Female, Male Male | 20 Participants | 35 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Hemoglobin A1c | 8.41 percentage of A1C | Standard Deviation 1.55 |
| Intervention | Hemoglobin A1c | 8.18 percentage of A1C | Standard Deviation 1.59 |