Discovery Program for Type 1 Diabetes

Overseen By Dina Bu, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Type 2 diabetes, physical, cognitive, others

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

Compensation: Varies

Number of Visits: 9

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called the Discovery Program to help manage type 1 diabetes in adolescents and young adults. The main goal is to determine if this program can improve blood sugar control and reduce diabetes-related stress. Participants will receive personalized mobile health messages and support from clinicians, while others will continue with their usual diabetes care. It suits young people with type 1 diabetes who have had the condition for at least a year, have a smartphone, and are part of the Vanderbilt health system. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes care strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on additional support for diabetes management rather than changing existing treatments.

What prior data suggests that the Discovery Program is safe for adolescents and young adults with type 1 diabetes?

Research shows that digital health tools can help manage type 1 diabetes. Studies have found that mobile health systems and telehealth models are generally easy for patients to use. For example, research on a diabetes care platform for young people with type 1 diabetes showed that these tools can safely support personalized care.

These studies reported no serious safety issues, indicating that mobile health tools like the Discovery Program are likely safe. Participants typically manage these digital tools well, with few negative effects. This suggests the Discovery Program's approach is likely safe for most people involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Discovery Program for Type 1 Diabetes because it offers a personalized approach to managing the condition. Unlike standard diabetes care, which typically involves routine medical check-ups and self-management education, this program provides tailored mobile health communications along with clinician support. This innovative method aims to enhance diabetes management through real-time, individualized guidance, potentially improving patient outcomes by addressing their specific needs and challenges.

What evidence suggests that the Discovery Program is effective for type 1 diabetes management?

Research shows that the Discovery Program, which provides personalized health tips via phone and support from healthcare professionals, might help young people with type 1 diabetes manage their condition more effectively. In this trial, participants in the intervention group will receive the Discovery Program, while the control group will continue with standard diabetes care. Studies suggest that such programs can help control blood sugar levels, as reflected in HbA1c tests, which measure average blood sugar over several months. Early results from similar programs indicate they can reduce stress related to diabetes management and enhance daily self-care skills. Although specific data on the Discovery Program's effectiveness is still being gathered, initial findings are promising for managing type 1 diabetes. ^{6 7 8 9 10}

Who Is on the Research Team?

Shelagh A Mulvaney, PhD

Principal Investigator

Vanderbilt University

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults with type 1 diabetes. Participants should be willing to engage in a 3-month program, complete surveys, and allow access to their health records. Specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I have been diagnosed with Type 1 Diabetes for over a year.

I am between 13 and 21 years old.

Access to a smartphone

Exclusion Criteria

I have been diagnosed with type 2 diabetes.

I can see, hear, and respond well enough to use a phone and participate in digital activities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in a 3-month intervention that includes personalized mobile health communications and clinician support

12 weeks

Baseline, 3 months, and 6 months assessments

Follow-up

Participants are monitored for changes in glycemic control, diabetes distress, and self-management skills

3 months

6 months and 9 months assessments

What Are the Treatments Tested in This Trial?

Interventions

• Discovery Program

Trial Overview The Discovery Program is being tested to see if it improves glycemic control (HbA1c levels), reduces diabetes distress, and enhances self-management skills compared to standard care. It involves personalized mobile communications and clinician support over three months.

How Is the Trial Designed?

Group I: Intervention Group: Discovery Program Experimental Treatment 1 Intervention

This arm will receive the Discovery Program intervention, which includes personalized mobile health communications and clinician support aimed at improving diabetes management.

Group II: Control Group: Standard Diabetes Care Active Control 1 Intervention

This arm will continue with standard diabetes care practices without the additional psychosocial intervention provided to the intervention group.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07116434

Study Details | NCT07116434 | Discovery Diabetes The Discovery Diabetes study is a pilot randomized controlled trial designed to evaluate the effectiveness of the Discovery Program in improving diabetes ...

2. grants.nih.gov grants.nih.gov/grants/guide/rfa-files/RFA-DK-26-007.html

RFA-DK-26-007: Collaborative Research Using ... Discovery and testing of biomarkers of type 1 diabetes in peripheral blood including correlates or drivers of: susceptibility, environmental ...

3. diabetes.org diabetes.org/newsroom/press-releases/american-diabetes-association-showcases-innovations-and-guidance-early-risk

American Diabetes Association Showcases Innovations ... The results of the study showed the probability of developing type 1 diabetes by two years was 4%, 17%, and 51% in the low, medium, and high ...

4. type1strong.org type1strong.org/blog-post/top-type-1-diabetes-research-breakthroughs-to-watch-in-2025

Top Type 1 Diabetes Research Breakthroughs to Watch in ... New and improved insulin pumps and continuous glucose monitors (CGMs), artificial pancreas systems, beta cell regeneration, encapsulation, ...

5. academic.oup.com academic.oup.com/jcem/article/110/8/2371/8103687

Establishing Screening Programs for Presymptomatic Type 1 ... T1D Exchange registry data revealed that people 25 to 40 years of age showed a considerable rate of DKA at T1D diagnosis, ranging from 19% to 24% (19). An ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10591058/

Artificial intelligence in diabetes management - PubMed Central Mobile phone-based pattern recognition and data analysis for patients with type 1 diabetes. Diabetes Technol. Therapeut. 2012;14:1098–1104. doi: 10.1089/dia ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2810132

Comprehensive Telehealth Model to Support Diabetes Self ... This cohort study examines glycemic outcome data for adults with type 1 or type 2 diabetes who participated in a virtual endocrinology ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03315663

Personalized Smartphone-assisted Coaching System to ... The study was withdrawn due to budgetary and other constraints. Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With ...

9. diabetes.jmir.org diabetes.jmir.org/2021/4/e29027/

Patient-Generated Data Analytics of Health Behaviors of ... The aim of this review is to investigate what can be learned about the health behaviors of those living with, or at risk of developing, T2D through analytics ...

10. nature.com nature.com/articles/s41746-024-01319-x

The adaptation of a single institution diabetes care platform ... Timely Interventions for Diabetes Excellence (TIDE) is a CDS and RPM tool that facilitates personalized care for youth with type 1 diabetes (T1D) ...