Type 1 Diabetes Screening
ConditionType 1 Diabetes (T1D)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorNorthwestern University
About this trial
This study examines how population-based screening for type 1 diabetes (T1D) using islet autoantibodies (i.e., immune system proteins) can be incorporated into pediatric primary care during routine well-child visits. The project evaluates whether this screening approach is feasible, acceptable, and appropriate for clinicians, parents, and other key constituent groups. The study also explores how often clinicians order the test and how often families complete it when integrated into existing workflows. Insights from parents, clinicians, and organizational leaders will inform future scale-up efforts and practical strategies to improve early detection of T1D in pediatric practices across the United States.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All children presenting for the 2-4, 6-8, and 11-15 year well-child visit at participating clinics, or otherwise eligible for T1D screening, or otherwise receiving blood test recommendations from clinicians that happen outside of these recommended age buckets or routine visits, will be eligible to have their data extracted from the electronic health record (EHR)
All pediatric physicians and non-physician primary care providers (MD, DO, APP) employed at participating clinics will be eligible to complete the post-visit interview.
All clinic staff at participating clinics, including members of the care team (e.g., medical assistants, nurses) as well as clinic leaders, administrative staff, and other staff (e.g., front-desk triage), will be eligible to complete the post-visit interview.
Disqualifiers
Parents/caregivers and children who have opted-out of participating in research at their clinic.
Trial population
Children and their parents/caregivers presenting for routine well-child visits at participating pediatric practices during the study period, as well as pediatric clinicians and clinic staff at participating practices who helped implement universal screening.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not applicable - observational study
Other interventionThis is an observational implementation study. The research team does not assign or deliver any clinical interventions. T1D screening orders and blood draws occur as part of routine care at clinician discretion, and the study observes EHR outcomes and collects surveys/interviews. Participating clinics receive implementation supports (education, facilitation, workflow integration, and consultation) to enable routine screening adoption. These are clinic wide quality improvement activities and are not research 'interventions' assigned to participants, and clinical decisions remain at clinician discretion.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Acceptability (Parent Perspective)
Parent perspectives will be assessed quantitatively through post-visit surveys by answering Likert-scale questions on the perceived acceptability of: (1) discussing T1D screening with a member of the care team during well-child visit and (2) having the child undergo a blood draw for T1D screening.
Time frame
Throughout study period (up to 18 months)2
Acceptability (Clinician Perspective)
Clinician perspectives will be assessed quantitatively through phone interviews by answering Likert-scale questions on the perceived acceptability of offering population-based T1D screening at recommended ages during routine well-child visits.
Time frame
Throughout study period (up to 18 months)3
Feasibility (Clinician Perspective)
Clinician perspectives will be assessed quantitatively through phone interviews by answering Likert-scale questions on: (1) the perceived feasibility of offering population-based T1D screening during well-child visits within the current workflow and (2) the perceived manageability of the logistics required to implement T1D screening in the practice.
Time frame
Throughout study period (up to 18 months)4
Appropriateness (Parent Perspective)
Parent perspectives will be assessed quantitatively through post-visit surveys by answering Likert-scale questions on the perceived relevance of T1D screening for the child.
Time frame
Throughout study period (up to 18 months)Secondary outcomes
1
Reach of T1D Screening
Reach will be calculated using both electronic health record (EHR) visit data and parent-reported data. Per EHR data, reach will be calculated as the number of children who completed the islet-autoantibody screening, divided by the number of eligible children during the study period. A secondary, less conservative calculation will use the number of completed screens divided by those for whom screening was ordered. EHR data is seen as the "ground truth" and parent-reported data will be used to supplement this information. Per parent-reported data, reach will be calculated as the number of parents who answered "yes" to the survey question asking if their child has completed the screening after their recent visit, divided by the total number of completed parent surveys.
Time frame
15-month implementation window2
Penetration of T1D Screening
Penetration will be calculated using both EHR visit data and parent-reported data. Per EHR data, penetration will be calculated as the number of children for whom clinicians ordered islet-autoantibody screening, divided by the number of eligible children during the study period. EHR data is seen as the "ground truth" and parent-reported data will be used to supplement this information. Per parent-reported data, penetration will be calculated as the number of parents who answered "yes" to the survey question asking if a member of the care team has ordered islet-autoantibody screening for their child during their recent visit, divided by the total number of completed parent surveys.
Time frame
15-month implementation windowLocations
Sponsors and contacts
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Northwestern University
Lead sponsor
Sanofi
Collaborator
Source ClinicalTrials.gov
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