Type 1 Diabetes (T1D)NCT07612475
Universal Type 1 Diabetes Screening in Pediatrics
An observational study of Type 1 Diabetes (T1D), run by Northwestern University at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Set of implementation strategies
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 9,500 participants
- Where
- 8 sitesUnited States
- Study dates
- 17 Jul 2026to 16 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children and their parents presenting for eligible well-child visits at participating pediatric practices, as well as pediatric clinicians and other care team members at participating practices.
Who may be able to join
- Children
- Clinics will be encouraged to select screening ages or visits that align with international consensus statements for screening during early childhood, mid-childhood, and preadolescence and routine U.S. well-child visit schedules, and that minimize workflow disruption and maximize screening completion, such as visits that already include blood draws for other routine tests (e.g., lead screening at age 2). Children who have visits at their clinic's selected ages will be eligible to have their data extracted from the electronic health record (EHR)
- Parents/Caregivers - All parents or legal guardians (hereafter, parents) who attended the well-child visit, who are eligible to have their child's EHR data extracted, and who are over age 18, will be eligible to complete the post-visit survey and interview.
- Clinicians and Other Care Team Members
- All pediatric primary care clinicians (i.e., physician [MD, DO], nurse practitioner, physician assistant) at participating clinics will be eligible to complete an interview.
- All other care team members, including nurses, medical assistants, phlebotomists, and front desk staff at participating clinics will be eligible to complete an interview.
Who cannot join
- Parents who have opted-out of survey recruitment at their clinic will not be eligible for the survey/interview.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites
Pediatric Associates of Alexander City
Alexander City, Alabama, 35010
RBK Pediatrics - Bay Shore
Bay Shore, New York, 11706
Bloom Pediatrics - Birmingham
Birmingham, Michigan, 48009
Bloom Pediatrics - Bloomfield
Bloomfield Township, Michigan, 48302
RBK Pediatrics - Commack
Commack, New York, 11725
Bloom Pediatrics - Detroit
Detroit, Michigan, 48201
Pediatrics of Greater Orlando
Orlando, Florida, 32835
Bloom Pediatrics - Southfield
Southfield, Michigan, 48034
About this study
Official title: Feasibility of Implementing Type One Diabetes Screening in Pediatric Clinics
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, supported by the study's implementation approach, is feasible, acceptable, and appropriate for clinicians, parents, and other key constituent groups. The study also explores how often clinicians order the test, how often patients complete it, and how often clinicians document stages of early-stage T1D in the patients' electronic health records. Insights from parents, clinicians, other care team members, pediatric endocrinologists, and national and regional experts will inform future scale-up efforts and practical strategies to improve early detection of T1D in pediatric practices across the United States.
Read the detailed description
Background:
Type 1 diabetes (T1D) is the most common form of diabetes in children and adolescents, affecting approximately 1 in 300 young people in the United States. The disease results from autoimmune destruction of pancreatic β-cells and often progresses silently over months to years before clinical symptoms emerge. Although first-degree relatives have a substantially higher risk of developing T1D, most children diagnosed with T1D do not have a family history of the disease. The presence of multiple islet autoantibodies is associated with an almost certain lifetime risk of insulin-requiring diabetes, and early identification before symptom onset can significantly reduce rates of life-threatening diabetic ketoacidosis (DKA), support structured monitoring, and potentially allow for disease-modifying interventions.
Despite clear benefits, early detection through autoantibody screening is not routinely implemented in U.S. pediatric primary care. Currently, screening largely occurs in research settings, and little is known about how best to integrate universal T1D screening into busy community pediatric practices. Key concerns include workflow burden, clinician capacity, limited availability of pediatric endocrinologists, parent understanding and acceptability, and other structural barriers such as insurance coverage. Emerging recommendations from leading professional organizations worldwide, including the International Society for Pediatric and Adolescent Diabetes and the American Diabetes Association, highlight the potential of population-based screening; however, practical strategies for real-world implementation remain underdeveloped.
This study is designed to generate practice-informed evidence on how universal T1D islet autoantibody screening can be feasibly, acceptably, and appropriately integrated into routine pediatric well-child visits. Guided by implementation science, the study evaluates a set of implementation strategies that includes clinician education, clinician ordering reminders, and facilitation.
Observational Study Model:
This 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 electronic health record (EHR) outcomes and collects surveys/interviews.
The research team will offer a set of implementation strategies to all participating clinics to enable routine screening adoption. These are clinic-wide activities and are not research 'interventions' assigned to participants, and clinical decisions remain at clinician discretion. These supports will not be randomly assigned.
Study Objectives:
- Assess feasibility, acceptability, and appropriateness of integrating population-based islet autoantibody screening for T1D into pediatric primary care. Preliminary implementation strategy effectiveness will also be examined by tracking the proportion of eligible individuals for which clinicians order screening (penetration), proportion of eligible individuals who complete screening (reach), and proportion of eligible individuals with ICD-10 codes documented for early-stage T1D (unspecified stage, E10.A0; Stage 1, E10.A1; Stage 2, E10.A2; clinical documentation).
- Understand perspectives of multiple constituent groups, including parents, clinicians, other care team members, pediatric endocrinologists, and national and regional experts on implementing population-based T1D screening as part of standard pediatric preventive care.
Findings from this study will inform future scale-up efforts and support the development of implementation strategies for integrating universal T1D screening across U.S. pediatric care settings.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Set of implementation strategies
- Keywords
- Implementation Science, Pediatrics, Type 1 Diabetes, Universal Screening, Islet Autoantibodies, Population-based Screening
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Set of implementation strategiesBehavioural
This 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.
The research team will deliver a set of implementation strategies (clinician education, clinician ordering reminders, and facilitation) to all participating clinics to enable routine screening adoption. These are clinic-wide activities and are not research 'interventions' assigned to participants, and clinical decisions remain at clinician discretion. These strategies will not be randomly assigned.
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (Clinician Perspective)
Feasibility of screening and implementation strategies will be assessed using items adapted from the Feasibility of Intervention Measure (FIM), administered verbally during interviews and rated on a five-point Likert scale ranging from completely agree (5) to completely disagree (1)
Measured: Towards the end of the study (approximately months 12-15)
Acceptability (Parent Perspective)
Parent perspectives on the acceptability (for both clinician recommendation of screening and undergoing a blood draw for screening; parents who received or completed each element will be asked about actual acceptability and those who didn't will be asked about anticipated acceptability). Survey questions will be adapted from the psychometrically validated Acceptability of Intervention Measure (AIM) and rated on a Likert-scale ranging from completely agree (5) to completely disagree (1).
Measured: Throughout study period (15 months)
Acceptability (Clinician Perspective)
Acceptability of screening and implementation strategies will be assessed using items adapted from the Acceptability of Intervention Measure (AIM), administered verbally during interviews and rated on a five-point Likert scale ranging from completely agree (5) to completely disagree (1)
Measured: Towards the end of the study (approximately months 12-15)
Appropriateness (Parent Perspective)
Parent perspectives on the appropriateness (i.e., relevance of screening; parents who completed screening will be asked about actual appropriateness and those who didn't will be asked about anticipated appropriateness). Survey questions will be adapted from the psychometrically validated Intervention Appropriateness Measure (IAM) and rated on a Likert-scale ranging from completely agree (5) to completely disagree (1).
Measured: Throughout study period (15 months)
Appropriateness (Clinician Perspective)
Appropriateness of screening and implementation strategies will be assessed using items adapted from the Intervention Appropriateness Measure (IAM), administered verbally during interviews and rated on a five-point Likert scale ranging from completely agree (5) to completely disagree (1)
Measured: Towards the end of the study (approximately months 12-15)
Secondary outcomes (3)
Penetration of T1D Screening
Penetration will be calculated from EHR data as proportion of patients who had screening ordered among those who were eligible to be screened
Measured: 15 months preceding study period and 15 months of study period
Reach of T1D Screening
Reach will be calculated from EHR data as the proportion of patients who completed screening among those eligible to be screened, a definition of reach which aligns with best practices in the literature. As a second, less conservative measure of reach, we will assess the proportion of patients who completed screening among those who had screening ordered for them.
Measured: 15 months preceding study period and 15 months of study period
Clinical Documentation
Clinical documentation will be measured from EHR data as the proportion of eligible patients with ICD-10 codes documented for early-stage T1D captured through screening (unspecified stage, E10.A0; Stage 1, E10.A1; Stage 2, E10.A2)
Measured: 15 months preceding study period and 15 months of study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start17 Jul 2026
- Primary completion16 Oct 2027 (estimated)
- Study completion16 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 9,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Rinad Beidas, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612475
- Sponsor's protocol ID
- STU00224090
- Status last verified
- Oct 2026
- First submitted
- 20 May 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Implementing Type One Diabetes Screening in Pediatric Clinics
- ClinicalTrials.gov ID
- NCT07612475
- Acronym / sponsor ID
- STU00224090
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- Implementation Science, Pediatrics, Type 1 Diabetes, Universal Screening, Islet Autoantibodies, Population-based Screening
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 9,500 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- 16 Oct 2027 (estimated)
- Study completion
- 16 Oct 2027 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, supported by the study's implementation approach, is feasible, acceptable, and appropriate for clinicians, parents, and other key constituent groups. The study also explores how often clinicians order the test, how often patients complete it, and how often clinicians document stages of early-stage T1D in the patients' electronic health records. Insights from parents, clinicians, other care team members, pediatric endocrinologists, and national and regional experts will inform future scale-up efforts and practical strategies to improve early detection of T1D in pediatric practices across the United States.
Detailed description
Background:
Type 1 diabetes (T1D) is the most common form of diabetes in children and adolescents, affecting approximately 1 in 300 young people in the United States. The disease results from autoimmune destruction of pancreatic β-cells and often progresses silently over months to years before clinical symptoms emerge. Although first-degree relatives have a substantially higher risk of developing T1D, most children diagnosed with T1D do not have a family history of the disease. The presence of multiple islet autoantibodies is associated with an almost certain lifetime risk of insulin-requiring diabetes, and early identification before symptom onset can significantly reduce rates of life-threatening diabetic ketoacidosis (DKA), support structured monitoring, and potentially allow for disease-modifying interventions.
Despite clear benefits, early detection through autoantibody screening is not routinely implemented in U.S. pediatric primary care. Currently, screening largely occurs in research settings, and little is known about how best to integrate universal T1D screening into busy community pediatric practices. Key concerns include workflow burden, clinician capacity, limited availability of pediatric endocrinologists, parent understanding and acceptability, and other structural barriers such as insurance coverage. Emerging recommendations from leading professional organizations worldwide, including the International Society for Pediatric and Adolescent Diabetes and the American Diabetes Association, highlight the potential of population-based screening; however, practical strategies for real-world implementation remain underdeveloped.
This study is designed to generate practice-informed evidence on how universal T1D islet autoantibody screening can be feasibly, acceptably, and appropriately integrated into routine pediatric well-child visits. Guided by implementation science, the study evaluates a set of implementation strategies that includes clinician education, clinician ordering reminders, and facilitation.
Observational Study Model:
This 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 electronic health record (EHR) outcomes and collects surveys/interviews.
The research team will offer a set of implementation strategies to all participating clinics to enable routine screening adoption. These are clinic-wide activities and are not research 'interventions' assigned to participants, and clinical decisions remain at clinician discretion. These supports will not be randomly assigned.
Study Objectives:
- Assess feasibility, acceptability, and appropriateness of integrating population-based islet autoantibody screening for T1D into pediatric primary care. Preliminary implementation strategy effectiveness will also be examined by tracking the proportion of eligible individuals for which clinicians order screening (penetration), proportion of eligible individuals who complete screening (reach), and proportion of eligible individuals with ICD-10 codes documented for early-stage T1D (unspecified stage, E10.A0; Stage 1, E10.A1; Stage 2, E10.A2; clinical documentation).
- Understand perspectives of multiple constituent groups, including parents, clinicians, other care team members, pediatric endocrinologists, and national and regional experts on implementing population-based T1D screening as part of standard pediatric preventive care.
Findings from this study will inform future scale-up efforts and support the development of implementation strategies for integrating universal T1D screening across U.S. pediatric care settings.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and their parents presenting for eligible well-child visits at participating pediatric practices, as well as pediatric clinicians and other care team members at participating practices.
Key inclusion criteria (6 listed)
- Children
- Clinics will be encouraged to select screening ages or visits that align with international consensus statements for screening during early childhood, mid-childhood, and preadolescence and routine U.S. well-child visit schedules, and that minimize workflow disruption and maximize screening completion, such as visits that already include blood draws for other routine tests (e.g., lead screening at age 2). Children who have visits at their clinic's selected ages will be eligible to have their data extracted from the electronic health record (EHR)
- Parents/Caregivers - All parents or legal guardians (hereafter, parents) who attended the well-child visit, who are eligible to have their child's EHR data extracted, and who are over age 18, will be eligible to complete the post-visit survey and interview.
- Clinicians and Other Care Team Members
- All pediatric primary care clinicians (i.e., physician [MD, DO], nurse practitioner, physician assistant) at participating clinics will be eligible to complete an interview.
Key exclusion criteria (1 listed)
- Parents who have opted-out of survey recruitment at their clinic will not be eligible for the survey/interview.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Set of implementation strategiesThis 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. The research team will deliver a set of implementation strategies (clinician education, clinician ordering reminders, and facilitation) to all participating clinics to enable routine screening adoption. These are clinic-wide activities and are not research 'interventions' assigned to participants, and clinical decisions remain at clinician discretion. These strategies will not be randomly assigned. | Behavioural | – |
Primary outcome
Feasibility (Clinician Perspective)
Time frame: Towards the end of the study (approximately months 12-15)
Feasibility of screening and implementation strategies will be assessed using items adapted from the Feasibility of Intervention Measure (FIM), administered verbally during interviews and rated on a five-point Likert scale ranging from completely agree (5) to completely disagree (1)
Acceptability (Parent Perspective)
Time frame: Throughout study period (15 months)
Parent perspectives on the acceptability (for both clinician recommendation of screening and undergoing a blood draw for screening; parents who received or completed each element will be asked about actual acceptability and those who didn't will be asked about anticipated acceptability). Survey questions will be adapted from the psychometrically validated Acceptability of Intervention Measure (AIM) and rated on a Likert-scale ranging from completely agree (5) to completely disagree (1).
Acceptability (Clinician Perspective)
Time frame: Towards the end of the study (approximately months 12-15)
Acceptability of screening and implementation strategies will be assessed using items adapted from the Acceptability of Intervention Measure (AIM), administered verbally during interviews and rated on a five-point Likert scale ranging from completely agree (5) to completely disagree (1)
Appropriateness (Parent Perspective)
Time frame: Throughout study period (15 months)
Parent perspectives on the appropriateness (i.e., relevance of screening; parents who completed screening will be asked about actual appropriateness and those who didn't will be asked about anticipated appropriateness). Survey questions will be adapted from the psychometrically validated Intervention Appropriateness Measure (IAM) and rated on a Likert-scale ranging from completely agree (5) to completely disagree (1).
Appropriateness (Clinician Perspective)
Time frame: Towards the end of the study (approximately months 12-15)
Appropriateness of screening and implementation strategies will be assessed using items adapted from the Intervention Appropriateness Measure (IAM), administered verbally during interviews and rated on a five-point Likert scale ranging from completely agree (5) to completely disagree (1)
3 secondary outcomes
Penetration of T1D Screening
Time frame: 15 months preceding study period and 15 months of study period
Reach of T1D Screening
Time frame: 15 months preceding study period and 15 months of study period
Clinical Documentation
Time frame: 15 months preceding study period and 15 months of study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes (T1D), run by Northwestern University at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (Clinician Perspective) (time frame: Towards the end of the study (approximately months 12-15)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.