Type 1 DiabetesPLEDGENCT04477928
General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery
An observational study of Type 1 Diabetes and Celiac Disease, run by Sanford Health at 4 sites in United States.
Trial summary
In partnership with Helmsley Charitable Trust, the Sanford PLEDGE Study is a large-scale, observational, feasibility study of general population screening for T1D and celiac autoantibodies. Screening is incorporated into routine health care visits within an integrated health system. Read more about this study
- Who is it for?
- Ages 0 minutes to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Celiac Disease
- What is being tested?
- Sera and whole blood sampling and Differential Gene Expression (DGE)
- How many people
- 33,000 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Jul 2020to Mar 2031
- 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 0 minutes to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children born at and/or followed at Sanford Health System facilities: 1. . 0-5 years of age; 2. . 9-16 years of age; 3. . Siblings of children known to have T1D-relevant antibodies, ages 6 to 17 years old.
Who may be able to join
- Newborn Entry: Viable, term infants, defined as 36 weeks gestation by either dates or ultrasound who are born to pregnant women, 18 years or older, who are willing and able to provide informed consent (IC) prior to the onset of active labor. Who are born at a Sanford Health Hospital and plan to have routine well-child care at a Sanford Clinic
- Pediatric Entry: Children less than 6 years of age who receive their routine care at a Sanford facility and whose parents are able to provide IC.
- Adolescent Entry: Children, ages 9-16 years old, who receive their routine care at a Sanford facility and whose parents are able to provide IC.
- Siblings of children known to have T1D-relevant antibodies; ages 6 to 17 years old who receive care at a Sanford clinic
- Have an active MyChart account (with proxy access).
Who cannot join
- Subject is in the opinion of the investigator, unable to comply with the requirements of the study protocol.
- Children known to have T1D
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Sanford Bemidji Region Clinics
Bemidji, Minnesota, 56601
Ann Mays, RN, CPN, 605-312-6052, ann.mays@sanfordhealth.org
Kurt Griffin, PhD, MD
- Recruiting
Sanford Bismarck Region Clinics
Bismarck, North Dakota, 58501
Ann Mays, RN, CPN, 605-312-6052, ann.mays@sanfordhealth.org
Kurt Griffin, PhD, MD
- Recruiting
Sanford Fargo Region Clinics
Fargo, North Dakota, 58112
Ann Mays, 605-312-6052, ann.mays@sanfordhealth.org
Kurt Griffin, PhD, MD
- Recruiting
Sanford Sioux Falls Region Clinics
Sioux Falls, South Dakota, 57105
Ann Mays, 6053126052, ann.mays@sanfordhealth.org
Kurt Griffin, PhD, MD
About this study
Official title: Sanford Population Level Estimation of Type 1 Diabetes Risk GEnes in Children
In partnership with Helmsley Charitable Trust, the Sanford PLEDGE Study is a large-scale, observational, feasibility study of general population screening for T1D and celiac autoantibodies. Screening is incorporated into routine health care visits within an integrated health system.
Read the detailed description
Most children with type 1 diabetes (T1D) do not have a family member with diabetes and often are not diagnosed until the child is very sick. Research suggests that screening and identifying children at risk for T1D autoantibodies can prevent serious illness at the time of diagnosis and improve long-term health outcomes.
The investigators will screen children, ages 0-5.99 or 9-16 years for blood markers related to T1D and celiac disease during routine healthcare delivery at birth, 1, 2 and 5 years, or once between 9 and 16 years of age. Children with confirmed autoantibodies will be offered participation in other monitoring or prevention trials (T1D), or referred to clinical care (celiac).
- Conditions
- Type 1 Diabetes, Celiac Disease
- Being tested
- Sera and whole blood sampling, Differential Gene Expression (DGE)
- Keywords
- Population screening, Type 1 Diabetes, Celiac Disease, Autoantibodies, Prevention, Diabetic Ketoacidosis (DKA), Genetic Risk Score, Differential Gene Expression, Economic Modeling, Quality of Life, Feasibility, Pragmatic, T1D
- Medical subject headings
- Diabetes Mellitus, Type 1, Celiac Disease, Diabetic Ketoacidosis, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sera and whole blood samplingDiagnostic test
- Study Entry: Single Nucleotide Polymorphism (SNP)-Based Genetic Risk Score at study entry.
- 2 years old: T1D autoantibodies, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antibodies
- 5 years old: T1D and celiac autoantibodies
- 9-16 year old: one-time T1D and celiac autoantibodies
- Siblings of people with T1D autoimmunity, ages 6-17 years: one-time T1D and celiac autoantibodies
Differential Gene Expression (DGE)Diagnostic test
Opt-in: Differential Gene Expression from cord blood at birth and peripheral blood at 12 months of age
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Children receiving routine care at a Sanford facility Receives: Diagnostic Test: Sera and whole blood sampling; Diagnostic Test: Differential Gene Expression (DGE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrated feasibility of large-scale population screening, as evidenced by:
- The percentage of parent(s) that viewed the MyChart study information who went on to complete the MyChart informed consent, HIPAA and questionnaires.
- Of those who consented to be in the study, the percentage who went on to obtain the initial sample.
- Of the total samples collected, percentage that were valid and results received.
- The percentage of subjects who complete their ~60 month visit by their 6th birthday.
Measured: By year 10 of the study
Secondary outcomes (8)
Seroconversion rates for T1D-relevant and celiac autoantibodies
Measured: By year 10 of study
Percentage of T1D seropositive subjects who enroll in another T1D monitoring or prevention study.
Measured: By year 10 of study
Percentage of celiac seropositive subjects referred on to GI or primary care
Measured: By year 10 of study
The percentage of celiac seropositive subjects who were evaluated in clinical setting
Measured: By year 10 of study
The rate of development of overt hyperglycemia consistent with T1D (Stage 3).
Measured: By year 10 of study
Proportion of participants developing overt hyperglycemia consistent with T1D (Stage 3), who present in diabetic ketoacidosis (DKA)
Measured: By year 10 of study
Number and type of procedure-related adverse events
Measured: By year 10 of study
Assessment of costs associated with implementation of study compared to potential impacts on cost and quality of life.
Measured: By year 10 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start17 Jul 2020
- Primary completionMar 2031 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- 33,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Pacific Northwest Research Institute, University of Exeter
- Responsible party
- Sponsor
- Investigators
- Kurt Griffin, PhD, MD, Principal investigator, Sanford Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477928
- Sponsor's protocol ID
- PLEDGE
- Acronym
- PLEDGE
- Status last verified
- Feb 2026
- First submitted
- 13 Jul 2020
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified patient characteristics, clinical and laboratory outcomes will be shared in an online platform.
Publications
Sims EK, Besser REJ, Dayan C, Geno Rasmussen C, Greenbaum C, Griffin KJ, Hagopian W, Knip M, Long AE, Martin F, Mathieu C, Rewers M, Steck AK, Wentworth JM, Rich SS, Kordonouri O, Ziegler AG, Herold KC; NIDDK Type 1 Diabetes TrialNet Study Group. Screening for Type 1 Diabetes in the General Population: A Status Report and Perspective. Diabetes. 2022 Apr 1;71(4):610-623. doi: 10.2337/dbi20-0054.
PubMed 35316839
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sanford Population Level Estimation of Type 1 Diabetes Risk GEnes in Children
- ClinicalTrials.gov ID
- NCT04477928
- Acronym / sponsor ID
- PLEDGE / PLEDGE
- Conditions
- Type 1 Diabetes, Celiac Disease
- Keywords
- Population screening, Type 1 Diabetes, Celiac Disease, Autoantibodies, Prevention, Diabetic Ketoacidosis (DKA), Genetic Risk Score, Differential Gene Expression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 33,000 participants (estimated)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Pacific Northwest Research Institute, University of Exeter
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 20 Jul 2020 (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.
In partnership with Helmsley Charitable Trust, the Sanford PLEDGE Study is a large-scale, observational, feasibility study of general population screening for T1D and celiac autoantibodies. Screening is incorporated into routine health care visits within an integrated health system.
Detailed description
Most children with type 1 diabetes (T1D) do not have a family member with diabetes and often are not diagnosed until the child is very sick. Research suggests that screening and identifying children at risk for T1D autoantibodies can prevent serious illness at the time of diagnosis and improve long-term health outcomes.
The investigators will screen children, ages 0-5.99 or 9-16 years for blood markers related to T1D and celiac disease during routine healthcare delivery at birth, 1, 2 and 5 years, or once between 9 and 16 years of age. Children with confirmed autoantibodies will be offered participation in other monitoring or prevention trials (T1D), or referred to clinical care (celiac).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Sera and whole blood sampling, Diagnostic Test: Differential Gene Expression (DGE)Children receiving routine care at a Sanford facility |
Who may qualify
- Ages
- 0 minutes to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children born at and/or followed at Sanford Health System facilities: 1. . 0-5 years of age; 2. . 9-16 years of age; 3. . Siblings of children known to have T1D-relevant antibodies, ages 6 to 17 years old.
Key inclusion criteria (5 listed)
- Newborn Entry: Viable, term infants, defined as 36 weeks gestation by either dates or ultrasound who are born to pregnant women, 18 years or older, who are willing and able to provide informed consent (IC) prior to the onset of active labor. Who are born at a Sanford Health Hospital and plan to have routine well-child care at a Sanford Clinic
- Pediatric Entry: Children less than 6 years of age who receive their routine care at a Sanford facility and whose parents are able to provide IC.
- Adolescent Entry: Children, ages 9-16 years old, who receive their routine care at a Sanford facility and whose parents are able to provide IC.
- Siblings of children known to have T1D-relevant antibodies; ages 6 to 17 years old who receive care at a Sanford clinic
- Have an active MyChart account (with proxy access).
Key exclusion criteria (2 listed)
- Subject is in the opinion of the investigator, unable to comply with the requirements of the study protocol.
- Children known to have T1D
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 |
|---|---|---|
| Sera and whole blood sampling* Study Entry: Single Nucleotide Polymorphism (SNP)-Based Genetic Risk Score at study entry. * 2 years old: T1D autoantibodies, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antibodies * 5 years old: T1D and celiac autoantibodies * 9-16 year old: one-time T1D and celiac autoantibodies * Siblings of people with T1D autoimmunity, ages 6-17 years: one-time T1D and celiac autoantibodies | Diagnostic test | Study Group |
| Differential Gene Expression (DGE)Opt-in: Differential Gene Expression from cord blood at birth and peripheral blood at 12 months of age | Diagnostic test | Study Group |
Primary outcome
Demonstrated feasibility of large-scale population screening, as evidenced by:
Time frame: By year 10 of the study
1. The percentage of parent(s) that viewed the MyChart study information who went on to complete the MyChart informed consent, HIPAA and questionnaires. 2. Of those who consented to be in the study, the percentage who went on to obtain the initial sample. 3. Of the total samples collected, percentage that were valid and results received. 4. The percentage of subjects who complete their ~60 month visit by their 6th birthday.
8 secondary outcomes
Seroconversion rates for T1D-relevant and celiac autoantibodies
Time frame: By year 10 of study
Percentage of T1D seropositive subjects who enroll in another T1D monitoring or prevention study.
Time frame: By year 10 of study
Percentage of celiac seropositive subjects referred on to GI or primary care
Time frame: By year 10 of study
The percentage of celiac seropositive subjects who were evaluated in clinical setting
Time frame: By year 10 of study
The rate of development of overt hyperglycemia consistent with T1D (Stage 3).
Time frame: By year 10 of study
Proportion of participants developing overt hyperglycemia consistent with T1D (Stage 3), who present in diabetic ketoacidosis (DKA)
Time frame: By year 10 of study
Number and type of procedure-related adverse events
Time frame: By year 10 of study
Assessment of costs associated with implementation of study compared to potential impacts on cost and quality of life.
Time frame: By year 10 of study
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 2 Mar 2026.
- Background: PubMed 35316839Sims EK, Besser REJ, Dayan C, Geno Rasmussen C, Greenbaum C, Griffin KJ, Hagopian W, Knip M, Long AE, Martin F, Mathieu C, Rewers M, Steck AK, Wentworth JM, Rich SS, Kordonouri O, Ziegler AG, Herold KC; NIDDK Type 1 Diabetes TrialNet Study Group. Screening for Type 1 Diabetes in the General Population: A Status Report and Perspective. Diabetes. 2022 Apr 1;71(4):610-623. doi: 10.2337/dbi20-0054.
- Individual participant dataSharing planned: Yes. Deidentified patient characteristics, clinical and laboratory outcomes will be shared in an online platform.
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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.
Kurt Griffin, PhD, MD principal investigator
Sanford Research
4 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 and Celiac Disease, run by Sanford Health at 4 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Contact Ann Mays, RN, CPN (605-312-6052, ann.mays@sanfordhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrated feasibility of large-scale population screening, as evidenced by: (time frame: By year 10 of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04477928, which also lists 1 linked publication.
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 2 Mar 2026.