Implementing the Spotlight AQ Platform in Adolescent/ Young Adult (16-25 Years Old) Type 1 Diabetics (T1D)

January 8, 2026 updated by: Cintya Schweisberger, Children's Mercy Hospital Kansas City

Spotlight AQ Randomized Controlled Trial of the Spotlight AQ Survey Platform to Evaluate Its' Efficacy and Applicability in a Clinic Setting.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 16-25 years old
  • Patients diagnosed with T1D for at least 6 months
  • On any diabetes treatment
  • Using a Continuous Glucose Monitor (CGM)
  • Willing/ able to use Spotlight AQ tool
  • Able to give verbal assent
  • Patients & parents/caregiver speak English/ Spanish fluently
  • Patients in the Children's Mercy Kansas City Hospital or Boston Children's Hospital network

Exclusion Criteria:

  • <16 years old or >25 years old
  • Mental illness that could seriously reduce their ability to participate in the study
  • Lack of capacity
  • In another T1D intervention study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention (Spotlight AQ)
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
Other: Spotlight AQ Survey platform
A psychosocial assessment pinpointing the needs of patients divided into four domains: Therapy, Psychological, Social, Knowledge which is delivered to health care providers to guide their in clinic visits
No Intervention: Standard of Care
The pre-clinic survey typically given to patients before clinic visits at each institution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 3 months (approximately)
HbA1c levels of pediatric participants as a %
3 months (approximately)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant satisfaction
Time Frame: 3 months (approximately)
Participant satisfaction with the survey as measured by the End of Study questionnaires. Participants indicate being unsatisfied- satisfied or not helped- helped, etc. within the questionnaires
3 months (approximately)
HCP satisfaction with the Spotlight survey
Time Frame: 3 months (approximately)
Healthcare Provider (HCP) satisfaction with the Spotlight survey as measured by their End of Study questionnaires. HCPs indicate being unsatisfied- satisfied or not helped- helped, etc. within the questionnaires
3 months (approximately)
T1D outcomes
Time Frame: 3 months (approximately)
T1D outcomes including Time in Range
3 months (approximately)
T1D outcomes
Time Frame: 3 months (approximately)
T1D outcomes including bolus scores
3 months (approximately)
The effectiveness of the intervention
Time Frame: 3 months (approximately)
The effectiveness evaluated in qualitative studies
3 months (approximately)
The approval of participants
Time Frame: 3 months (approximately)
The approval of participants evaluated in qualitative studies
3 months (approximately)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Cintya Schweisberger, DO, Children's Mercy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002936

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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