DiabetesTExT-MEDNCT01403831
Trial to Examine Text-message Based mHealth in Emergency Department Patients With Diabetes
A study testing Daily text messages in people with Diabetes, run by University of Southern California at 1 site in United States.
Trial summary
The investigators propose an innovative, ED-based mHealth intervention: TExT-MED (Trial to Examine Text-Based mHealth for Emergency department patients with Diabetes). TExT-MED is a technologically simple solution using unidirectional daily text messages to consisting of educational materials, trivia questions and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Daily text messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) ≥18 years old 2) have Type 2 diabetes 3) have a text message capable mobile phone 4) know how to receive text messages 5) speak and read English or Spanish and 6) have a HbA1C ≥8%.
Who cannot join
- 1) overt psychosis 2) unable to provide informed consent and 3) pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
The investigators propose an innovative, ED-based mHealth intervention: TExT-MED (Trial to Examine Text-Based mHealth for Emergency department patients with Diabetes). TExT-MED is a technologically simple solution using unidirectional daily text messages to consisting of educational materials, trivia questions and challenges promoting healthy lifestyle choices and reminders to check blood sugar, take medications and go to clinic appointments. The investigators believe TExT-MED will improve health outcomes including blood glucose control and encourage weight loss, healthy eating and exercise. TExT-MED is low cost, easy to use and can be quickly adapted to other practice environments.
- Conditions
- Diabetes
- Being tested
- Daily text messages
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily text messagesOther
2-3 times daily text messages regarding diabetes care and healthy lifestyle choices
| Study group | Role | What they receive |
|---|---|---|
| Text messages | Experimental | Patients randomized to this arm will receive daily text messages to their mobile phones consisting of educational materials, motivational materials, trivia questions, and challenges to engage in healthy lifestyle choices Receives: Other: Daily text messages |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C at 6 months
Measured: 6 months
Secondary outcomes (3)
DIet/ Weight Loss
Measured: 6 months
Diabetes self-efficacy/empowerment
Measured: 6 months
Diabetes knowledge
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjay Arora, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403831
- Sponsor's protocol ID
- HS-11-00084
- Other IDs
- Mobilizing for Health
- Acronym
- TExT-MED
- Status last verified
- Jun 2013
- First submitted
- 25 Jul 2011
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arora S, Peters AL, Agy C, Menchine M. A mobile health intervention for inner city patients with poorly controlled diabetes: proof-of-concept of the TExT-MED program. Diabetes Technol Ther. 2012 Jun;14(6):492-6. doi: 10.1089/dia.2011.0252. Epub 2012 Apr 23.
PubMed 22524591
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Examine Text-message Based mHealth in Emergency Department Patients With Diabetes
- ClinicalTrials.gov ID
- NCT01403831
- Acronym / sponsor ID
- TExT-MED / HS-11-00084
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose an innovative, ED-based mHealth intervention: TExT-MED (Trial to Examine Text-Based mHealth for Emergency department patients with Diabetes). TExT-MED is a technologically simple solution using unidirectional daily text messages to consisting of educational materials, trivia questions and challenges promoting healthy lifestyle choices and reminders to check blood sugar, take medications and go to clinic appointments. The investigators believe TExT-MED will improve health outcomes including blood glucose control and encourage weight loss, healthy eating and exercise. TExT-MED is low cost, easy to use and can be quickly adapted to other practice environments.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text messages | Experimental | Other: Daily text messagesPatients randomized to this arm will receive daily text messages to their mobile phones consisting of educational materials, motivational materials, trivia questions, and challenges to engage in healthy lifestyle choices |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) ≥18 years old 2) have Type 2 diabetes 3) have a text message capable mobile phone 4) know how to receive text messages 5) speak and read English or Spanish and 6) have a HbA1C ≥8%.
Key exclusion criteria (1 listed)
- 1) overt psychosis 2) unable to provide informed consent and 3) pregnancy.
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 |
|---|---|---|
| Daily text messages2-3 times daily text messages regarding diabetes care and healthy lifestyle choices | Other | Text messages |
Primary outcome
Hemoglobin A1C at 6 months
Time frame: 6 months
3 secondary outcomes
DIet/ Weight Loss
Time frame: 6 months
Diabetes self-efficacy/empowerment
Time frame: 6 months
Diabetes knowledge
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
- Derived from this study: PubMed 22524591Arora S, Peters AL, Agy C, Menchine M. A mobile health intervention for inner city patients with poorly controlled diabetes: proof-of-concept of the TExT-MED program. Diabetes Technol Ther. 2012 Jun;14(6):492-6. doi: 10.1089/dia.2011.0252. Epub 2012 Apr 23.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily text messages in people with Diabetes, run by University of Southern California 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 1 inclusion and 1 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 19 Jun 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01403831, which also lists 1 linked publication.
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 19 Jun 2013; AzTrials last refreshed its copy on 7 Nov 2026.