Personalized Text Messaging for Type 2 Diabetes

(REINFORCE2 Trial)

Overseen By Julie Lauffenburger, PharmD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must be taking: Oral diabetes medications

Disqualifiers: Pillbox use, Daily medication help

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether personalized text messages can help people with type 2 diabetes adhere to their medication routine. A smart system, known as Reinforcement Learning, adjusts the messages based on individual responses. Participants will receive either tailored messages that evolve over time or standard messages. The study targets individuals with type 2 diabetes who take 1-3 daily pills and have recent blood sugar levels (HbA1c) of 7% or higher. Suitable candidates should own a smartphone and manage their medication independently. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve diabetes management for many.

Do I need to stop my current medications for this trial?

The trial does not specify that you need to stop taking your current medications. It focuses on supporting medication adherence for those already prescribed 1-3 daily oral medications for type 2 diabetes.

What prior data suggests that this text messaging intervention is safe for patients with type 2 diabetes?

Research has shown that using reinforcement learning to send personalized text messages has succeeded in other studies. These studies found that tailored messages help individuals remember to take their medication. Importantly, no reports of harmful effects or safety issues have emerged with this approach. Since the treatment involves sending text messages, it is generally considered safe and easy to manage. Because this study uses a similar method, participants can expect a low risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the personalized text messaging approach for managing Type 2 diabetes because it uses reinforcement learning to tailor messages specifically to each individual's needs. Unlike standard care options like medication, diet, and exercise plans that follow a more general approach, this method adapts to the recipient's progress and challenges, offering customized support. This personalization has the potential to enhance patient engagement and improve adherence to healthy behaviors, which could lead to better management of blood sugar levels and overall health outcomes.

What evidence suggests that this reinforcement learning intervention is effective for medication adherence in type 2 diabetes?

Research has shown that using reinforcement learning to personalize text messages can help people with type 2 diabetes adhere to their medication schedules. In this trial, participants in the Reinforcement Learning Intervention Arm will receive up to daily, tailored text messages. One study found that these personalized messages improved medication adherence. Another study demonstrated that these messages could also boost physical activity, which is crucial for managing diabetes. This method adjusts messages based on individual responses, making them more engaging and encouraging healthier habits. Overall, evidence suggests that this approach can improve health outcomes for those with type 2 diabetes. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-84 with type 2 diabetes who have a recent HbA1c level of at least 7.5%, use a smartphone, understand English or Spanish, take 1-3 daily oral diabetes meds, and have been less than ideally consistent with their medication (PDC <0.80). It's not for those getting daily help with meds or unwilling to switch to electronic pill bottles.

Inclusion Criteria

Must have a basic working knowledge of English or Spanish

I have been diagnosed with Type 2 Diabetes.

I take 1 to 3 pills daily for my diabetes.

Exclusion Criteria

Receive help at home on a daily basis with taking medications

Currently using a pillbox and/or not willing to use electronic pill bottles for 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to daily text messages, tailored or untailored, to support medication adherence

6 months

Follow-up

Participants are monitored for medication adherence and glycemic control after the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Reinforcement Learning

Trial Overview The study tests if personalized text messages based on reinforcement learning can improve medication adherence in type 2 diabetes patients compared to standard texts. Participants will be randomly assigned to receive either tailored messages that adapt over time or generic ones, both potentially up to daily.

How Is the Trial Designed?

Group I: Reinforcement Learning Intervention Arm Experimental Treatment 1 Intervention

Up to daily, tailored text messages.

Group II: Control Arm Active Control 1 Intervention

Up to daily, untailored text messages.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11496924/

Effectiveness of a Digital Health Intervention Leveraging ... Our study found that applying a reinforcement learning algorithm for personalizing text messaging interventions is an effective approach for ...

2. nature.com nature.com/articles/s41746-024-01028-5

The impact of using reinforcement learning to personalize ... In this randomized-controlled trial of a reinforcement learning intervention that personalized text messaging content for patients with diabetes ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8647547/

REinforcement learning to improve non-adherence for ... REinforcement learning to improve non-adherence for diabetes treatments by Optimising Response and Customising Engagement (REINFORCE): study protocol of a ...

4. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/improving-diabetes-and-depression-self-management-adaptive-mobile-messaging

Improving Diabetes and Depression Self-Management Via ... The use of reinforcement learning algorithms for personalizing text messaging interventions can increase physical activity in a diverse sample of people with ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05742685

Refinement and Adaption of Reinforcement Learning to ... The goal of the proposed research is to refine, adapt and perform efficacy testing of a novel reinforcement learning-based text messaging intervention to ...

6. withpower.com withpower.com/trial/phase-diabetes-mellitus-type-2-3-2023-54438

Personalized Text Messaging for Type 2 Diabetes ... Trial Overview The study tests if personalized text messages based on reinforcement learning can improve medication adherence in type 2 diabetes patients ...

7. bmjopen.bmj.com bmjopen.bmj.com/content/11/12/e052091

study protocol of a pragmatic randomised trial The objective of this trial is to test the impact of a reinforcement learning-based text messaging programme on adherence to medication for patients with type ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6481002/

Tailored mobile text messaging interventions targeting type ... This study aimed to identify, assess and summarize available scientific evidence on tailored text messaging interventions focused on type 2 diabetes ...