Texting Intervention for Diabetes

(DD-TXT Trial)

Recruiting at 3 trial locations

Overseen By Timothy P Hogan, PhD MS BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Non-veterans, No phone access, Visual impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

366 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

One way to help Veterans improve their diabetes control is through the use of technology to help provide information, motivation, and reminders necessary to support diabetes self-management. The study will seek input from diverse groups of Veterans living with diabetes to help develop a new customizable, interactive texting intervention that allows Veterans to choose what kinds of diabetes self-management support they need, and when. This diabetes support will be provided to Veterans through "Annie for Veterans", a VA texting system for self-management support. Patients will be randomized to receive a once-daily standard diabetes self-management texting intervention called DSMS based on standard diabetes self-management education content or a customizable, patient-centered diabetes self-management support intervention with additional features called DSMS Plus (DSMS+) in order to test the comparative effectiveness of these two texting interventions.

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.

Is the texting intervention for diabetes safe for humans?

The texting intervention for diabetes, used in various programs, has been shown to be a low-cost and feasible way to support diabetes management and prevention. While specific safety data is not detailed, the intervention involves sending supportive text messages, which is generally considered safe for human use. ^{1 2 3 4 5}

How is the DD-TXT treatment for diabetes unique?

The DD-TXT treatment is unique because it uses personalized text messages to support diabetes management, offering a low-cost, instant, and widely accessible way to help patients manage their condition through reminders and educational prompts tailored to their needs. ^{4 5 6 7 8}

What data supports the effectiveness of the treatment DD-TXT, DSE for diabetes?

Research shows that sending educational and motivational text messages can improve diabetes management by increasing knowledge, self-care, and medication adherence, leading to better blood sugar control. ^{9 10 11 12 13}

Who Is on the Research Team?

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

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?

Group I: DSMS+ (DSMS Plus) Experimental Treatment 1 Intervention

Participants in this group were signed up for an interactive, patient-centered, and customizable diabetes self-management support texting intervention (DSMS+). This arm received the same daily educational content as the DSMS arm augmented by the following: regular two-way check-in messages about diabetes self-management behaviors, an invitation to receive messages written by other Veterans living with diabetes on demand, and a menu of optional and customizable modules (e.g., medication reminders, blood sugar and blood pressure monitoring,: physical activity reminders, weight management, and goal setting) from which participants could select messaging that supported their diabetes self-management goals. Patients could customize the timing and frequency of their messages. DSMS+ participants also received a once monthly message asking whether the messages had been helpful.

Group II: DSMS Active Control 1 Intervention

Participants in the comparison condition were signed up for a one-way education-only protocol called Diabetes Self-Management Support (DSMS), comprised of 6 months of once daily one-way text messages covering standard diabetes self-management education content. Starting with the VA educational workbook entitled "Self-Care Skills for the Person with Diabetes", created in alignment with VA/DoD diabetes guidelines, we enhanced the educational content by incorporating Veteran input through a co-design process with Veterans living with diabetes and expert clinician review. DSMS messages could not be customized. There was no interactive content for the DSMS arm other than a once monthly message asking whether the messages had been helpful.

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

A new trial is testing the effectiveness of SMS text messages designed to improve medication adherence in adults with type 2 diabetes, involving 958 participants over 12 months, aiming to reduce cardiovascular risk.

Preliminary feasibility studies indicate that these SMS messages are acceptable to patients and successfully influence medication adherence, setting the stage for this larger trial to assess their impact compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial. Farmer, A., Jones, L., Newhouse, N., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Only 9 out of 792 studies on SMS interventions for type 2 diabetes management in the U.S. met the inclusion criteria, highlighting a significant gap in research on this topic.

While 63% of participants in these studies were non-white, there was a lack of cultural adaptations and comprehensive sociodemographic data, indicating a need for more inclusive and tailored interventions for diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disparities in Text Messaging Interventions to Improve Diabetes Management in the United States. Eyler, AA., Gachupin, FC., Johnston, SL., et al.[2022]

Supplemental text messaging (SMS4PreDM) was appealing to participants, particularly younger individuals and those from underserved populations, but it did not significantly enhance attendance or weight loss outcomes in the in-person National Diabetes Prevention Program (NDPP).

The study involved 488 participants over a year, comparing those who received in-person NDPP classes with and without the SMS4PreDM support, highlighting the need for further research to find effective strategies for improving NDPP outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplemental Text Message Support With the National Diabetes Prevention Program: Pragmatic Comparative Effectiveness Trial. Ritchie, ND., Gutiérrez-Raghunath, S., Durfee, MJ., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Text-Message Self-Management Support Program (SMS4BG): A Pilot Study. Dobson, R., Carter, K., Cutfield, R., et al.[2018]

A total of 124 SMS text messages were developed to support diet and exercise behavior change after a diabetes prevention program, using the Behaviour Change Wheel framework to ensure they were theory-based and effective.

After evaluation by 18 participants, 61.3% of the messages were refined for clarity and relevance, resulting in a final bank of 120 messages that were well-received by both users and coaches, demonstrating a structured approach to developing effective mobile health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation and Refinement of a Bank of SMS Text Messages to Promote Behavior Change Adherence Following a Diabetes Prevention Program: Survey Study. MacPherson, M., Cranston, K., Johnston, C., et al.[2021]

A two-way text messaging program aimed at providing behavioral coaching and reminders for diabetes management did not significantly improve glycemic control (A1C levels) compared to usual care in a study of 93 patients over 6 months.

Despite the lack of significant differences in A1C changes, patient satisfaction with the text messaging program was very high, indicating that while it may not have improved glycemic control, it was well-received by participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Going mobile with diabetes support: a randomized study of a text message-based personalized behavioral intervention for type 2 diabetes self-care. Capozza, K., Woolsey, S., Georgsson, M., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Text Message Intervention for Latino Adults to Improve Diabetes Outcomes. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of text message based, diabetes self management support programme (SMS4BG): two arm, parallel randomised controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Digital messaging to support control for type 2 diabetes (StAR2D): a multicentre randomised controlled trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of short message service intervention to improve glycated hemoglobin control and medication adherence in type-2 diabetes: A meta-analysis of prospective studies. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Disparities in Text Messaging Interventions to Improve Diabetes Management in the United States. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Supplemental Text Message Support With the National Diabetes Prevention Program: Pragmatic Comparative Effectiveness Trial. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Development of Text Messages to Support People at Risk of Diabetes in Low-Resourced Communities: The South African Diabetes Prevention Programme. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Diabetes Text-Message Self-Management Support Program (SMS4BG): A Pilot Study. [2018]

10. Canada pubmed.ncbi.nlm.nih.gov

Evaluation and Refinement of a Bank of SMS Text Messages to Promote Behavior Change Adherence Following a Diabetes Prevention Program: Survey Study. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Texting Adolescents in Repeat DKA and Their Caregivers. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Going mobile with diabetes support: a randomized study of a text message-based personalized behavioral intervention for type 2 diabetes self-care. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Computerized Automated Reminder Diabetes System (CARDS): e-mail and SMS cell phone text messaging reminders to support diabetes management. [2022]