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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06390371
• Other study ID #: STUDY00002936
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2024
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Children's Mercy Hospital Kansas City
• Contact: Priscilla Connell, MPH
• Phone: 816-601-4543
• Email: pcconnell[@]cmh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	Children's Mercy	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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. Erratum In: Diabetes Technol Ther. 2019 Apr;21(4):230. — View 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. — View 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

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. — View 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. — View 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. — View 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. — View Citation

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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	HbA1c levels of pediatric participants as a %	3 months (approximately)
Secondary	Participant satisfaction	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)
Secondary	HCP satisfaction with the Spotlight survey	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)
Secondary	T1D outcomes	T1D outcomes including Time in Range	3 months (approximately)
Secondary	T1D outcomes	T1D outcomes including bolus scores	3 months (approximately)
Secondary	The effectiveness of the intervention	The effectiveness evaluated in qualitative studies	3 months (approximately)
Secondary	The approval of participants	The approval of participants evaluated in qualitative studies	3 months (approximately)