What is the mechanism of action of this treatment?

Common treatments for diabetes, particularly those involving telehealth and digital health literacy, focus on improving patients' ability to manage their condition through education and remote monitoring. These interventions often include live self-management education via telehealth platforms and text-based messages that encourage healthy behaviors. The primary mechanism of action is enhancing patients' knowledge and skills to manage their blood glucose levels, adhere to medication regimens, and make informed lifestyle choices. This approach is crucial for diabetes patients as it empowers them to take control of their health, potentially leading to better glycemic control and reduced complications.

What side effects are associated with this type of intervention?

Common treatments for diabetes, such as those studied in telehealth distance learning platforms, include lifestyle modifications, oral medications, and insulin therapy. Lifestyle changes typically have minimal side effects but may cause initial fatigue or muscle soreness. Oral medications like metformin can lead to gastrointestinal issues such as nausea, diarrhea, and abdominal discomfort. Insulin therapy may result in hypoglycemia, weight gain, and injection site reactions. Patients should discuss these potential side effects with their healthcare providers to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of diabetes, including GLP-1 agonists such as liraglutide and extended-release exenatide, and SGLT2 inhibitors like dapagliflozin. Liraglutide has been shown to improve glycemic control and was approved for pediatric use in 2019. Extended-release exenatide was approved in 2021 for adolescents. Dapagliflozin has also been approved for use in children 10 years and older. These treatments align with the goals of telehealth interventions, which aim to improve digital health literacy and self-management skills in diabetes patients through remote education.

What other types of research exist?

Promising, novel alternatives to the Telehealth Distance Learning Platform for diabetes patients in 2024 include: 1) Mobile apps like QuitGuide, quitSTART, and Stay Quit Coach 2, which can be adapted to track blood sugar levels, provide motivational messaging, and offer educational resources. 2) Social network platforms such as Twitter, Facebook, and WhatsApp, which can be used to create support groups and deliver educational content. 3) Interactive and tailored web-based tools similar to those offered by Smokefree.gov, which can provide personalized diabetes management plans, educational materials, and progress tracking.

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Digital Diabetes Self-Management for Diabetes (Dulce Digital Trial)

N/A

Recruiting

Led By Athena Philis-Tsimikas, MD

Research Sponsored by Scripps Whittier Diabetes Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Type 2 Diabetes

Be older than 18 years old

Must not have

Not willing to carry a mobile phone

Severe illness precluding visits to clinic

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing three ways to help underserved adults with diabetes manage their condition: in-person classes, online group sessions, and text messages. The goal is to see which method works best for people who often face challenges like low income and limited access to healthcare. By teaching them how to manage their diabetes, the study aims to help them make healthier choices and control their blood sugar levels better.

Who is the study for?

This trial is for Hispanic/Latino adults with Type 2 Diabetes, registered at Scripps Health, and an HbA1c level ≥8% in the last 60 days. It's not for those with recent substance abuse issues, severe health problems like anemia or liver dysfunction, minimal literacy, or who don't speak Spanish/English.

What is being tested?

Dulce Digital 2.0 evaluates two digital adaptations of Project Dulce aimed at improving diabetes self-management via text messages and telehealth platforms compared to traditional in-person education.

What are the potential side effects?

Since this trial involves educational interventions rather than medications, typical drug side effects are not expected. However, participants may experience discomfort from increased engagement with technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Type 2 Diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not willing to carry a mobile phone.

Select...

I am too ill to visit the clinic for treatments.

Select...

My primary language is not English or Spanish.

Select...

I have severe hearing or vision problems.

Select...

I have anemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months

Change from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months

Secondary study objectives

Change from Baseline Diabetes Distress (DDS-17) at 3 months

Change from Baseline Diabetes Distress (DDS-17) at 6 months

Change from Baseline Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 3 months

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Project Dulce Telehealth DSME/SExperimental Treatment1 Intervention

Patients will participate in live a peer-led Telehealth diabetes self-management education and support program.

Group II: Project Dulce Live DSME/SExperimental Treatment1 Intervention

Patients will participate in live a peer-led Telehealth diabetes self-management education and support program.

Group III: Dulce DigitalExperimental Treatment1 Intervention

Patients will participate in a text-based diabetes self-management educational and support (DSME/S) program and receive ongoing support via text messages designed to improve knowledge, health beliefs, self-management behaviors and clinical outcomes.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for diabetes, particularly those involving telehealth and digital health literacy, focus on improving patients' ability to manage their condition through education and remote monitoring. These interventions often include live self-management education via telehealth platforms and text-based messages that encourage healthy behaviors. The primary mechanism of action is enhancing patients' knowledge and skills to manage their blood glucose levels, adhere to medication regimens, and make informed lifestyle choices. This approach is crucial for diabetes patients as it empowers them to take control of their health, potentially leading to better glycemic control and reduced complications.

E-health education interventions on HbA1c in patients with type 1 diabetes on intensive insulin therapy: A systematic review and meta-analysis of randomized controlled trials.Effectiveness of Telemedicine Solutions for the Management of Patients With Diabetes: Protocol for a Systematic Review and Meta-Analysis.Effectiveness of technology-assisted case management in low income adults with type 2 diabetes (TACM-DM): study protocol for a randomized controlled trial.