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

NCT06390371 | Recruiting

• 1 other identifier: STUDY00002936
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c

  HbA1c levels of pediatric participants as a %

  3 months (approximately)

Secondary Outcomes (6)

• Participant satisfaction

  3 months (approximately)

• HCP satisfaction with the Spotlight survey

  3 months (approximately)

• T1D outcomes

  3 months (approximately)

• T1D outcomes

  3 months (approximately)

• The effectiveness of the intervention

  3 months (approximately)

Study Arms (2)

Intervention (Spotlight AQ)

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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

Interventions

Spotlight AQ Survey platform OTHER

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

Intervention (Spotlight AQ)

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy

Kansas City, Missouri, 64111, United States

RECRUITING

Related Publications (12)

• Foster NC, Beck RW, Miller KM, Clements MA, Rickels MR, DiMeglio LA, Maahs DM, Tamborlane WV, Bergenstal R, Smith E, Olson BA, Garg SK. State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016-2018. Diabetes Technol Ther. 2019 Feb;21(2):66-72. doi: 10.1089/dia.2018.0384. Epub 2019 Jan 18.

  PMID: 30657336 BACKGROUND

• Barnard KD, Lloyd CE, Dyson PA, Davies MJ, O'Neil S, Naresh K, Lawton J, Ziegler R, Holt RI. Kaleidoscope model of diabetes care: time for a rethink? Diabet Med. 2014 May;31(5):522-30. doi: 10.1111/dme.12400.

  PMID: 24506524 BACKGROUND

• Reith TP. Burnout in United States Healthcare Professionals: A Narrative Review. Cureus. 2018 Dec 4;10(12):e3681. doi: 10.7759/cureus.3681.

  PMID: 30761233 BACKGROUND

• Halbesleben JR, Rathert C. Linking physician burnout and patient outcomes: exploring the dyadic relationship between physicians and patients. Health Care Manage Rev. 2008 Jan-Mar;33(1):29-39. doi: 10.1097/01.HMR.0000304493.87898.72.

  PMID: 18091442 BACKGROUND

• Barnard-Kelly K. Utilizing eHealth and Telemedicine Technologies to Enhance Access and Quality of Consultations: It's Not What You Say, It's the Way You Say It. Diabetes Technol Ther. 2019 Jun;21(S2):S241-S247. doi: 10.1089/dia.2019.0015.

  PMID: 31169431 BACKGROUND

• Barnard-Kelly K, Kelly RC, Chernavvsky D, Lal R, Cohen L, Ali A. Feasibility of Spotlight Consultations Tool in Routine Care: Real-World Evidence. J Diabetes Sci Technol. 2022 Jul;16(4):939-944. doi: 10.1177/1932296821994088. Epub 2021 Mar 12.

  PMID: 33709795 BACKGROUND

• International Diabetes Federation Diabetes Atlas 9th Edition, 2019. https://diabetesatlas.org/en/sections/individual-social-and-economic-impact.html last accessed 16th November 2020

  BACKGROUND

• Patton SR, Clements MA, Fridlington A, Cohoon C, Turpin AL, Delurgio SA. Frequency of mealtime insulin bolus as a proxy measure of adherence for children and youths with type 1 diabetes mellitus. Diabetes Technol Ther. 2013 Feb;15(2):124-8. doi: 10.1089/dia.2012.0229. Epub 2013 Jan 14.

  PMID: 23317372 BACKGROUND

• Kelly RC, Phiri P, Price H, Ali A, Stratton I, Austin K, Neave A, Barnard-Kelly K. Protocol paper: multi-Centre randomised controlled trial evaluating a pre-clinic diabetes assessment and mapped care planning intervention amongst adults with type 1, type 2 or pre-diabetes. Trials. 2022 Jun 20;23(1):515. doi: 10.1186/s13063-022-06475-7.

  PMID: 35725626 BACKGROUND

• Patton SR, DeLurgio SA, Fridlington A, Cohoon C, Turpin AL, Clements MA. Frequency of mealtime insulin bolus predicts glycated hemoglobin in youths with type 1 diabetes. Diabetes Technol Ther. 2014 Aug;16(8):519-23. doi: 10.1089/dia.2013.0356. Epub 2014 Apr 28.

  PMID: 24773597 BACKGROUND

• Clements MA, DeLurgio SA, Williams DD, Habib S, Halpin K, Patton SR. Association of HbA1c to BOLUS Scores Among Youths with Type 1 Diabetes. Diabetes Technol Ther. 2016 Jun;18(6):351-9. doi: 10.1089/dia.2015.0352.

  PMID: 27258122 BACKGROUND

• McConville A, Noser AE, Clements MA, Patton SR. Mealtime insulin BOLUS score increases prior to clinic visits in youth with type 1 diabetes. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001348. doi: 10.1136/bmjdrc-2020-001348.

  PMID: 32665313 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Cintya Schweisberger, DO

  Children's Mercy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Priscilla Connell, MPH

CONTACT

816-601-4543; pcconnell@cmh.edu

Cintya Schweisberger, DO

CONTACT

cschweisberger@cmh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 30, 2024
• Study Start: May 27, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)