Spotlight AQ Platform for Type 1 Diabetes

Overseen By Emily DeWit

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Must be taking: Diabetes treatments

Disqualifiers: Mental illness, Lack of capacity, others

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

Compensation: Varies

Number of Visits: 2

Duration: 3 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare the Spotlight AQ survey platform to the standard of care (SOC) pre-clinic assessment in adolescents \& young adults (16-25 years old) with Type 1 Diabetes (T1D). The main questions it aims to answer are: * Does using the Spotlight AQ survey in clinic decrease the A1c in the people who use it? * Do patients and healthcare providers like using the spotlight AQ survey? Participants will use the Spotlight AQ survey before coming in to two standard of care T1D clinic visits Participants will fill out surveys describing how they feel about using the Spotlight AQ survey. Some participants may be asked to do an interview to talk about how they feel about the Spotlight AQ survey.

Do I have to stop taking my current medications for this trial?

The trial does not specify whether you need to stop taking your current medications. However, since it involves using a survey tool rather than testing a new medication, it's unlikely that you would need to change your current diabetes treatment.

What data supports the effectiveness of the Spotlight AQ Survey platform treatment for type 1 diabetes?

The research highlights the success of quality improvement initiatives in diabetes care, which involve sharing data and best practices among clinics to improve care delivery. These initiatives have shown success in improving processes and outcomes for people with type 1 diabetes, suggesting that similar collaborative approaches, like the Spotlight AQ Survey platform, could be effective. ^{1 2 3 4 5}

Research Team

Mark Clements, MD, PhD

Principal Investigator

Children's Mercy

Eligibility Criteria

This trial is for young people aged 16-25 with Type 1 Diabetes. Participants will use the Spotlight AQ survey before two standard clinic visits and provide feedback on their experience.

Inclusion Criteria

I can verbally agree to participate.

I am between 16 and 25 years old.

Willing/able to use Spotlight AQ tool

Exclusion Criteria

My mental health allows me to fully participate in a study.

I am unable to make my own medical decisions.

I am either younger than 16 or older than 25.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Spotlight AQ survey before attending two standard of care T1D clinic visits

3 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Spotlight AQ Survey platform

Trial Overview The study is testing if the Spotlight AQ survey platform can improve A1c levels compared to usual care in young diabetics. It also evaluates user satisfaction from both patients and healthcare providers.

Participant Groups

Group I: Intervention (Spotlight AQ) Experimental Treatment 1 Intervention

Spotlight AQ is an Artificial Intelligence (AI) powered adaptive survey which identifies the main concerns and gaps in patients tailored to their specific needs in preparation for clinic visits

Group II: Standard of Care Active Control 1 Intervention

The pre-clinic survey typically given to patients before clinic visits at each institution

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Findings from Research

Despite advancements in treatment, clinical outcomes for individuals with type 1 diabetes remain suboptimal, highlighting the need for quality improvement (QI) initiatives.

The T1D Exchange Quality Improvement Collaborative was developed to enhance care delivery and health outcomes in type 1 diabetes, emphasizing the importance of ongoing QI efforts in addressing medical, psychosocial, and health equity challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality Improvement in Diabetes Care: A Review of Initiatives and Outcomes in the T1D Exchange Quality Improvement Collaborative. Ginnard, OZB., Alonso, GT., Corathers, SD., et al.[2023]

The Type 1 Diabetes Composite Score (T1DCS) was developed to provide a comprehensive measure of diabetes management beyond just hemoglobin A1c, incorporating nine key elements of care for approximately 1,900 patients.

The implementation of T1DCS showed improved scores over time, indicating enhanced diabetes management and patient outcomes, thus proving its effectiveness as a quality measure in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Type 1 Diabetes Composite Score: An Innovative Metric for Measuring Patient Care Outcomes Beyond Hemoglobin A1c. Indyk, JA., Buckingham, D., Obrynba, KS., et al.[2022]

The Type 1 Diabetes Exchange Quality Improvement Collaborative (T1DX-QI) has successfully expanded over 8 years to include various centers across the U.S., leading to significant improvements in type 1 diabetes care.

Key factors for the collaborative's success include data-sharing, benchmarking, and peer collaboration, with future plans to involve more centers focused on adult care and underserved communities to enhance care for all individuals with type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline Quality Improvement Capacity of 33 Endocrinology Centers Participating in the T1D Exchange Quality Improvement Collaborative. Marks, BE., Mungmode, A., Neyman, A., et al.[2023]

The T1D Exchange established a collaborative platform involving 10 diabetes clinics to enhance the quality of care for individuals with type 1 diabetes through shared data and best practices.

Initial implementation of this Quality Improvement Collaborative has shown success in improving care processes by using quality improvement methodologies and iterative testing cycles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishment of the T1D Exchange Quality Improvement Collaborative (T1DX-QI). Alonso, GT., Corathers, S., Shah, A., et al.[2022]

Achieving glycemic targets in patients with type 1 diabetes (T1D) remains challenging, highlighting the need for quality improvement (QI) methodologies to enhance management strategies and patient outcomes.

The article emphasizes the importance of self-management and technology integration in T1D care, proposing novel QI interventions that can improve glycemic control and patient experiences, particularly in pediatric populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-system-based interventions to improve care in pediatric and adolescent type 1 diabetes. Corathers, SD., Schoettker, PJ., Clements, MA., et al.[2018]

References

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

Quality Improvement in Diabetes Care: A Review of Initiatives and Outcomes in the T1D Exchange Quality Improvement Collaborative. [2023]

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

The Type 1 Diabetes Composite Score: An Innovative Metric for Measuring Patient Care Outcomes Beyond Hemoglobin A1c. [2022]

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

Baseline Quality Improvement Capacity of 33 Endocrinology Centers Participating in the T1D Exchange Quality Improvement Collaborative. [2023]

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

Establishment of the T1D Exchange Quality Improvement Collaborative (T1DX-QI). [2022]

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

Health-system-based interventions to improve care in pediatric and adolescent type 1 diabetes. [2018]