Clinical trial NCT06390371: Implementing the Spotlight AQ Platform in Adolescent/ Young Adult (16-25 Years Old) Type 1 Diabetics (T1D)
Official title: Spotlight AQ Randomized Controlled Trial of the Spotlight AQ Survey Platform to Evaluate Its' Efficacy and Applicability in a Clinic Setting.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: 3 months (approximately)
Secondary outcomes:
measure: Participant satisfaction
timeFrame: 3 months (approximately)
measure: HCP satisfaction with the Spotlight survey
timeFrame: 3 months (approximately)
measure: T1D outcomes
timeFrame: 3 months (approximately)
measure: T1D outcomes
timeFrame: 3 months (approximately)
measure: The effectiveness of the intervention
timeFrame: 3 months (approximately)
measure: The approval of participants
timeFrame: 3 months (approximately)
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy
state: Missouri
Study officials:
affiliation: Children's Mercy
name: Mark Clements, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Reith TP. Burnout in United States Healthcare Professionals: A Narrative Review. Cureus. 2018 Dec 4;10(12):e3681. doi: 10.7759/cureus.3681.
citation: 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.
citation: 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.
citation: 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.
citation: International Diabetes Federation Diabetes Atlas 9th Edition, 2019. https://diabetesatlas.org/en/sections/individual-social-and-economic-impact.html last accessed 16th November 2020
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.