Spotlight AQ Platform for Type 1 Diabetes

Overseen By Cintya Schweisberger, DO

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new tool, the Spotlight AQ survey, to determine if it can manage Type 1 Diabetes (T1D) more effectively than the usual pre-clinic assessment. The researchers aim to discover whether this survey can lower A1c levels (a measure of blood sugar control) and if both patients and healthcare providers prefer using it. Participants will complete the survey before two clinic visits and share their thoughts through follow-up surveys or interviews. The trial seeks individuals aged 16-25 who have had T1D for at least six months, use a Continuous Glucose Monitor (CGM), and are part of certain hospital networks. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management research.

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 prior data suggests that the Spotlight AQ survey platform is safe for use in adolescents and young adults with Type 1 Diabetes?

Research has shown that the Spotlight AQ survey is generally easy to use and does not cause problems. Past studies found that using Spotlight AQ made doctor visits shorter and more helpful, with some positive effects on mental and emotional health. No reports of serious side effects from using the survey exist.

This study does not test a new drug or medical procedure. Instead, it examines whether the survey can improve diabetes care by addressing patient concerns before doctor visits, making it less risky than drug trials. Most evidence suggests that using Spotlight AQ is safe and may help improve overall diabetes management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Spotlight AQ Platform for Type 1 Diabetes because it leverages artificial intelligence to personalize patient care in a way that standard pre-clinic surveys do not. Unlike traditional surveys, the Spotlight AQ uses AI to tailor questions and identify specific concerns and gaps for each patient before their clinic visit. This personalized approach aims to enhance the effectiveness of clinic visits by addressing individual patient needs more precisely, potentially improving overall management of Type 1 Diabetes.

What evidence suggests that the Spotlight AQ survey platform is effective for Type 1 Diabetes?

Research has shown that the Spotlight AQ survey platform, which participants in this trial may receive, can enhance clinic visits for people with Type 1 Diabetes. Studies found that using Spotlight AQ led to shorter and more effective doctor visits. It also helped lower HbA1c levels, a measure of blood sugar control. Additionally, patients experienced moderate improvements in their feelings about diabetes, such as reduced stress and anxiety. This survey helps doctors focus on what matters most to each patient. ^{1 3 6 7 8}

Who Is on the Research Team?

Cintya Schweisberger, DO

Principal Investigator

Children's Mercy

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37350136/

Spotlight-AQ Pivotal Multicenter Randomized Controlled ... Spotlight-AQ was associated with shorter, more useful consultations; with improved HbA1c and moderate benefits on psychosocial outcomes.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06390371

NCT06390371 | Implementing the Spotlight AQ Platform in ... 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 ...

3. breakthrought1d.org breakthrought1d.org/grants/united-states/missouri/spotlight-aq-2-center-rct/

Spotlight-AQ 2 Center RCT This proposal seeks to collect initial data on the acceptability, feasibility, and effectiveness of Spotlight AQ in this vulnerable population. The ...

4. diabetesjournals.org diabetesjournals.org/diabetes/article/72/Supplement_1/1059-P/149371/1059-P-Spotlight-AQ-RCT-and-AI-Results-Improving

1059-P: Spotlight-AQ RCT and AI Results—Improving ... Spotlight-AQ was associated with shorter, more useful consultations; with improved HbA1c and moderate benefits on psychosocial outcomes.

5. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/spotlight-tools-to-improve-routine-clinical-care/

Spotlight Tools to Improve Routine Clinical Care The primary outcome was consultation length, with secondary outcomes of: HbA1c depression, diabetes distress, anxiety, functional health status and HCP burnout.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11688703/

Spotlight-AQ Pivotal Multicenter Randomized Controlled ... Spotlight-AQ was associated with shorter, more useful consultations; with improved HbA1c and moderate benefits on psychosocial outcomes.

7. withpower.com withpower.com/trial/phase-type-1-diabetes-mellitus-4-2024-c2d6c

Spotlight AQ Platform for Type 1 Diabetes This N/A medical study run by Children's Mercy Hospital Kansas City is evaluating whether Spotlight AQ Survey platform will have tolerable side effects ...

8. spotlight-aq.com spotlight-aq.com/

Spotlight-AQ | Diabetes Spotlight-AQ reduces diabetes-related complications and hospital admissions, thereby significantly lowering overall healthcare costs.