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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Standard of Care | No Intervention | The pre-clinic survey typically given to patients before clinic visits at each institution |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | HbA1c levels of pediatric participants as a % | 3 months (approximately) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| HCP satisfaction with the Spotlight survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cintya Schweisberger, DO | Children's Mercy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy | Kansas City | Missouri | 64111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30657336 | Background | 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. | |
| 24506524 | Background |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 | T1D outcomes including Time in Range | 3 months (approximately) |
| T1D outcomes | T1D outcomes including bolus scores | 3 months (approximately) |
| The effectiveness of the intervention | The effectiveness evaluated in qualitative studies | 3 months (approximately) |
| The approval of participants | The approval of participants evaluated in qualitative studies | 3 months (approximately) |
| 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. |
| 30761233 | Background | Reith TP. Burnout in United States Healthcare Professionals: A Narrative Review. Cureus. 2018 Dec 4;10(12):e3681. doi: 10.7759/cureus.3681. |
| 18091442 | 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. |
| 31169431 | 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. |
| 33709795 | 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. |
| 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 |
| 23317372 | 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. |
| 35725626 | 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. |
| 24773597 | 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. |
| 27258122 | 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. |
| 32665313 | 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |