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| Name | Class |
|---|---|
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
| Pacific Northwest Research Institute | OTHER |
| University of Exeter | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Children receiving routine care at a Sanford facility |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sera and whole blood sampling | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrated feasibility of large-scale population screening, as evidenced by: |
| By year 10 of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rates for T1D-relevant and celiac autoantibodies | By year 10 of study | |
| Percentage of T1D seropositive subjects who enroll in another T1D monitoring or prevention study. | By year 10 of study |
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Inclusion Criteria:
Exclusion Criteria:
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Children born at and/or followed at Sanford Health System facilities:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ann Mays, RN, CPN | Contact | 605-312-6052 | ann.mays@sanfordhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Kurt Griffin, PhD, MD | Sanford Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanford Bemidji Region Clinics | Recruiting | Bemidji | Minnesota | 56601 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35316839 | Background | 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. |
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Deidentified patient characteristics, clinical and laboratory outcomes will be shared in an online platform.
Data will be available no later than 12 months after the conclusion of study.
Data available to researchers approved by investigators.
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|
| Differential Gene Expression (DGE) | Diagnostic Test | Opt-in: Differential Gene Expression from cord blood at birth and peripheral blood at 12 months of age |
|
| Percentage of celiac seropositive subjects referred on to GI or primary care | By year 10 of study |
| The percentage of celiac seropositive subjects who were evaluated in clinical setting | By year 10 of study |
| The rate of development of overt hyperglycemia consistent with T1D (Stage 3). | By year 10 of study |
| Proportion of participants developing overt hyperglycemia consistent with T1D (Stage 3), who present in diabetic ketoacidosis (DKA) | By year 10 of study |
| Number and type of procedure-related adverse events | By year 10 of study |
| Assessment of costs associated with implementation of study compared to potential impacts on cost and quality of life. | By year 10 of study |
| Sanford Bismarck Region Clinics | Recruiting | Bismarck | North Dakota | 58501 | United States |
|
| Sanford Fargo Region Clinics | Recruiting | Fargo | North Dakota | 58112 | United States |
|
| Sanford Sioux Falls Region Clinics | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
|
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D002446 | Celiac Disease |
| D016883 | Diabetic Ketoacidosis |
| D000096442 | Genetic Risk Score |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007662 | Ketosis |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D048909 | Diabetes Complications |
| D020022 | Genetic Predisposition to Disease |
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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