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NCT Number: NCT06390371

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy

Kansas City, Missouri, 64111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. HbA1c

    Time frame: 3 months (approximately)

    HbA1c levels of pediatric participants as a %

Secondary outcomes

  1. 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

  2. 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. T1D outcomes

    Time frame: 3 months (approximately)

    T1D outcomes including Time in Range

  4. T1D outcomes

    Time frame: 3 months (approximately)

    T1D outcomes including bolus scores

  5. The effectiveness of the intervention

    Time frame: 3 months (approximately)

    The effectiveness evaluated in qualitative studies

  6. The approval of participants

    Time frame: 3 months (approximately)

    The approval of participants evaluated in qualitative studies

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 30, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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