Type 1 Diabetes Mellitus
Conditions
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.
Interventions
OTHERSpotlight 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
Sponsors
Children's Mercy Hospital Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 25 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 3 months (approximately) | HbA1c levels of pediatric participants as a % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant satisfaction | 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 |
| HCP satisfaction with the Spotlight survey | 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 |
| T1D outcomes | 3 months (approximately) | T1D outcomes including Time in Range |
| The effectiveness of the intervention | 3 months (approximately) | The effectiveness evaluated in qualitative studies |
| The approval of participants | 3 months (approximately) | The approval of participants evaluated in qualitative studies |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCintya Schweisberger, DO
Children's Mercy
Outcome results
None listed