Texting Intervention for Diabetes

(DD-TXT Trial)

No longer recruiting at 3 trial locations
SL
TP
Overseen ByTimothy P Hogan, PhD MS BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Veterans with type 2 diabetes manage their condition better using text messages. Participants will receive either a standard daily educational text or a more interactive and customizable text service (DD-TXT) that includes personalized reminders and motivational messages. The goal is to determine which texting method more effectively supports diabetes management. Veterans with type 2 diabetes who regularly visit VA outpatient services and have struggled with blood sugar control might be a good fit for this trial. As an unphased trial, this study offers Veterans a unique opportunity to explore innovative ways to manage their diabetes through personalized support.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a texting system to support diabetes management, so it's likely you can continue your current treatment.

What prior data suggests that this texting intervention is safe for diabetes self-management?

Previous studies have shown that similar text message support systems for managing diabetes have been well-received by participants. For example, one study found that using mobile phone support in diabetes programs across different countries was both safe and appreciated by participants. No major problems related to these texting systems have been reported.

Another study demonstrated that text-based education for managing diabetes can help lower HbA1c levels, an important measure of blood sugar control, without causing harm. This indicates that these systems are not only safe but also beneficial for managing diabetes.

Overall, research shows that these texting systems are safe for use and can improve diabetes management.12345

Why are researchers excited about this trial?

Researchers are excited about this texting intervention for diabetes because it offers a highly personalized and interactive approach to diabetes management, unlike traditional methods that often rely on static education or medication. The DSMS+ arm stands out by enabling two-way communication, allowing patients to receive and customize supportive messages about their self-management behaviors, which can include medication reminders and exercise prompts. This interactive element, combined with the option to receive peer-written messages, provides a more engaging and supportive environment for managing diabetes, potentially improving adherence and outcomes.

What evidence suggests that this trial's texting interventions could be effective for diabetes?

Research has shown that digital programs for managing diabetes can help people better control their blood sugar. These programs often use text messages and have been linked to improved health for those with type 2 diabetes. For instance, one study found that these digital programs not only improved blood sugar levels but also enhanced quality of life. Another study noted that these interventions helped lower A1c levels, a measure of long-term blood sugar control. In this trial, participants in the DSMS+ arm will receive a program that allows for two-way communication and personalization, potentially providing more support by letting participants customize messages to meet their personal health goals.678910

Who Is on the Research Team?

SL

Stephanie L Shimada, PhD

Principal Investigator

VA Bedford HealthCare System, Bedford, MA

Are You a Good Fit for This Trial?

This trial is for Veterans with type 2 diabetes who have struggled to control their blood sugar levels. They must be scheduled for a future appointment, able to text, and not visually impaired. Participants need access to a cell phone or smartphone and at least four VA outpatient visits in the past year.

Inclusion Criteria

Have a future appointment scheduled, and not be hospitalized or institutionalized or have participated in Aim 1 DD-TXT development
Your blood sugar has not been well controlled for at least half of the 6 months before joining the study.
Have had at least 4 VA outpatient encounters in the previous year
See 4 more

Exclusion Criteria

Non-Veterans

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the DD-TXT or DSE texting protocol for diabetes self-management for 6 months

6 months

Follow-up

Participants are monitored for changes in HbA1c, self-reported adherence, diabetes distress, LDL, and blood pressure control

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • DD-TXT
  • DSE
Trial Overview The study tests DD-TXT, an interactive texting intervention that helps Veterans manage their diabetes via 'Annie', a VA texting system. It's compared against DSE, an education-only text based on a diabetes workbook. Patients are randomly assigned to one of these two interventions.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: DSMS+ (DSMS Plus)Experimental Treatment1 Intervention
Group II: DSMSActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Published Research Related to This Trial

In a pilot study involving 40 insulin-treated adolescents and young adults, cell phone text messaging significantly increased the frequency of blood glucose monitoring compared to e-mail reminders, with participants receiving an average of 180.4 reminders versus 106.6.
While text messaging proved to be an effective method for engaging users initially, maintaining consistent usage over the 3-month period was challenging, indicating a need for strategies to sustain interest in the long term.
Computerized Automated Reminder Diabetes System (CARDS): e-mail and SMS cell phone text messaging reminders to support diabetes management.Hanauer, DA., Wentzell, K., Laffel, N., et al.[2022]
A meta-analysis of 10 studies involving 380 interventions showed that distance education and SMS reminders significantly reduced HbA1c levels in type-2 diabetes patients, with an overall effect size of -0.49%.
The same interventions also improved medication adherence, with a strong effect size of 0.96, indicating that texting reminders can be an effective strategy for managing diabetes over the first 6 months.
Effectiveness of short message service intervention to improve glycated hemoglobin control and medication adherence in type-2 diabetes: A meta-analysis of prospective studies.Zhuang, Q., Chen, F., Wang, T.[2022]
The SMS4BG intervention, a tailored text message support program for diabetes management, was found to be highly acceptable and useful among participants, with 93% reporting positive experiences after a 3-month pilot study involving 42 adults with poorly controlled diabetes.
Participants experienced a significant decrease in HbA1c levels, indicating improved glycemic control, suggesting that SMS4BG may effectively support diabetes self-management, although further research through a randomized controlled trial is needed to confirm its long-term efficacy.
Diabetes Text-Message Self-Management Support Program (SMS4BG): A Pilot Study.Dobson, R., Carter, K., Cutfield, R., et al.[2018]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40007461/
Diabetes self-management education and support ...mHealth interventions delivering self management education with or without support to adults with type 2 diabetes appear to have a modest beneficial effect on ...
Results from a 2-year diabetes self-management support ...This study examined the long-term impact of a 24-month, empowerment-based diabetes self-management support (DSMS) intervention on sustaining health-gains.
340-OR: Outcomes of a Digital Diabetes Self-Management ...Conclusions: Outcomes suggest that a digital DSMS program can improve glycemic control, as previously reported, but also PROs, and that a ...
Community-based diabetes self-management and support ...This study examined pre- to post-program quality of life outcomes for participants in a community-based diabetes-self management and support (DSMS) program.
Comparative effectiveness of diabetes self-management ...This RCT highlights the universal benefits of self-paced virtual diabetes self-management interventions to reduce A1c among Texans with unmanaged T2DM.
The effect of text message support on diabetes self ...This TEXT4DSM study implemented a mobile phone intervention in existing diabetes programmes in three low- and middle-income countries.
Diabetes self‐management education and support delivered ...This systematic review and meta‐analysis showed that unidirectional diabetes self‐management education and support delivered is effective in reducing HbA1c.
Results from a 2-year diabetes self-management support ...Conclusions. Findings suggest that an empowerment-based DSMS model can sustain or improve diabetes-related health gains achieved from previous short-term DSME.
Secure Messaging, Diabetes Self-management, and the ...Objective: We examined the association between healthcare team-initiated SM and diabetes self-management and self-efficacy, and whether this association was ...
How to facilitate peer supportResults indicate that the intervention was well-received, with participants engaging in meaningful exchange about diabetes self-management (DSM). However, those ...
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