Type 2 Diabetes MellitusNCT02488785
Impact of a Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With T2 Diabetes
A study testing Virtual Diabetes Self-Care and Education Program, Fitbit and Smartphone in people with Type 2 Diabetes Mellitus, run by Joslin Diabetes Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Virtual Diabetes Self-Care and Education Program, Fitbit and Smartphone
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Doctors Hospital at Renaissance
Edinburg, Texas, 78539
About this study
Official title: The Impact of a Comprehensive Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With Type 2 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Virtual Diabetes Self-Care and Education Program, Fitbit, Smartphone
- Keywords
- Type 2 Diabetes Mellitus, Telehealth, Hispanics, Latinos, Self-Care, Mobile Health, mHealth
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Diabetes Self-Care and Education ProgramBehavioural
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.
FitbitDevice
Also called physical activity tracker
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.
SmartphoneDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in this group will attend regular clinical and education appointments as offered by the clinic for their diabetes care. |
| Intervention | Experimental | 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. Receives: Behavioral: Virtual Diabetes Self-Care and Education Program; Device: Fitbit; Device: Smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startJun 2015
- Primary completion31 Mar 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Verizon Foundation, DHR Health Institute for Research and Development
- Responsible party
- Sponsor
- Investigators
- Sylvia E Rosas, MD, Principal investigator, Joslin Diabetes CenterMarcel Twahirwa, MD, Principal investigator, Doctors Hospital at Reinassance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488785
- Sponsor's protocol ID
- 2014-42
- Status last verified
- Aug 2022
- First submitted
- 4 Jun 2015
- Last updated
- 6 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Comprehensive Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02488785
- Acronym / sponsor ID
- 2014-42
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Telehealth, Hispanics, Latinos, Self-Care, Mobile Health, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Verizon Foundation, DHR Health Institute for Research and Development
- Study start
- Jun 2015 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Posted 6 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in this group will attend regular clinical and education appointments as offered by the clinic for their diabetes care. |
| Intervention | Experimental | Behavioral: Virtual Diabetes Self-Care and Education Program, Device: Fitbit, Device: SmartphonePatients 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Diabetes Self-Care and Education ProgramParticipants 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. | Behavioural | Intervention |
| FitbitAlso: physical activity trackerParticipants 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. | Device | Intervention |
| SmartphoneAll 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 | Device | Intervention |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvia E Rosas, MD principal investigator
Joslin Diabetes Center
Marcel Twahirwa, MD principal investigator
Doctors Hospital at Reinassance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Diabetes Self-Care and Education Program, Fitbit and Smartphone in people with Type 2 Diabetes Mellitus, run by Joslin Diabetes Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.