<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04477928</url>
  </required_header>
  <id_info>
    <org_study_id>PLEDGE</org_study_id>
    <nct_id>NCT04477928</nct_id>
  </id_info>
  <brief_title>General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery</brief_title>
  <acronym>PLEDGE</acronym>
  <official_title>Sanford Population Level Estimation of Type 1 Diabetes Risk GEnes in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanford Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Leona M. and Harry B. Helmsley Charitable Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pacific Northwest Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Exeter</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sanford Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In partnership with Helmsley Charitable Trust, the Sanford PLEDGE Study is a large-scale,&#xD;
      observational, feasibility study of general population screening for T1D and celiac&#xD;
      autoantibodies. Screening is incorporated into routine health care visits within an&#xD;
      integrated health system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Most children with type 1 diabetes (T1D) do not have a family member with diabetes and often&#xD;
      are not diagnosed until the child is very sick. Research suggests that screening and&#xD;
      identifying children at risk for T1D autoantibodies can prevent serious illness at the time&#xD;
      of diagnosis and improve long-term health outcomes.&#xD;
&#xD;
      The investigators will screen children, ages 0-5.99 or 9-16 years for blood markers related&#xD;
      to T1D and celiac disease during routine healthcare delivery at birth, 1, 2 and 5 years, or&#xD;
      once between 9 and 16 years of age. Children with confirmed autoantibodies will be offered&#xD;
      participation in other monitoring or prevention trials (T1D), or referred to clinical care&#xD;
      (celiac).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 17, 2020</start_date>
  <completion_date type="Anticipated">March 2031</completion_date>
  <primary_completion_date type="Anticipated">March 2031</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Demonstrated feasibility of large-scale population screening, as evidenced by:</measure>
    <time_frame>By year 10 of the study</time_frame>
    <description>The percentage of parent(s) that viewed the MyChart study information who went on to complete the MyChart informed consent, HIPAA and questionnaires.&#xD;
Of those who consented to be in the study, the percentage who went on to obtain the initial sample.&#xD;
Of the total samples collected, percentage that were valid and results received.&#xD;
The percentage of subjects who complete their ~60 month visit by their 6th birthday.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Seroconversion rates for T1D-relevant and celiac autoantibodies</measure>
    <time_frame>By year 10 of study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of T1D seropositive subjects who enroll in another T1D monitoring or prevention study.</measure>
    <time_frame>By year 10 of study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of celiac seropositive subjects referred on to GI or primary care</measure>
    <time_frame>By year 10 of study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of celiac seropositive subjects who were evaluated in clinical setting</measure>
    <time_frame>By year 10 of study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of development of overt hyperglycemia consistent with T1D (Stage 3).</measure>
    <time_frame>By year 10 of study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants developing overt hyperglycemia consistent with T1D (Stage 3), who present in diabetic ketoacidosis (DKA)</measure>
    <time_frame>By year 10 of study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and type of procedure-related adverse events</measure>
    <time_frame>By year 10 of study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of costs associated with implementation of study compared to potential impacts on cost and quality of life.</measure>
    <time_frame>By year 10 of study</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">33000</enrollment>
  <condition>Type 1 Diabetes</condition>
  <condition>Celiac Disease</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <description>Children receiving routine care at a Sanford facility</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sera and whole blood sampling</intervention_name>
    <description>Study Entry: Single Nucleotide Polymorphism (SNP)-Based Genetic Risk Score at study entry.&#xD;
2 years old: T1D autoantibodies, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antibodies&#xD;
5 years old: T1D and celiac autoantibodies&#xD;
9-16 year old: one-time T1D and celiac autoantibodies&#xD;
Siblings of people with T1D autoimmunity, ages 6-17 years: one-time T1D and celiac autoantibodies</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Differential Gene Expression (DGE)</intervention_name>
    <description>Opt-in: Differential Gene Expression from cord blood at birth and peripheral blood at 12 months of age</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children born at and/or followed at Sanford Health System facilities:&#xD;
&#xD;
          1. . 0-5 years of age;&#xD;
&#xD;
          2. . 9-16 years of age;&#xD;
&#xD;
          3. . Siblings of children known to have T1D-relevant antibodies, ages 6 to 17 years old.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newborn Entry: Viable, term infants, defined as 36 weeks gestation by either dates or&#xD;
             ultrasound who are born to pregnant women, 18 years or older, who are willing and able&#xD;
             to provide informed consent (IC) prior to the onset of active labor. Who are born at a&#xD;
             Sanford Health Hospital and plan to have routine well-child care at a Sanford Clinic&#xD;
&#xD;
          -  Pediatric Entry: Children less than 6 years of age who receive their routine care at a&#xD;
             Sanford facility and whose parents are able to provide IC.&#xD;
&#xD;
          -  Adolescent Entry: Children, ages 9-16 years old, who receive their routine care at a&#xD;
             Sanford facility and whose parents are able to provide IC.&#xD;
&#xD;
          -  Siblings of children known to have T1D-relevant antibodies; ages 6 to 17 years old who&#xD;
             receive care at a Sanford clinic&#xD;
&#xD;
          -  Have an active MyChart account (with proxy access).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is in the opinion of the investigator, unable to comply with the requirements&#xD;
             of the study protocol.&#xD;
&#xD;
          -  Children known to have T1D&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Minutes</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kurt Griffin, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sanford Research</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ann Mays, RN, CPN</last_name>
    <phone>605-312-6052</phone>
    <email>ann.mays@sanfordhealth.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sanford Bemidji Region Clinics</name>
      <address>
        <city>Bemidji</city>
        <state>Minnesota</state>
        <zip>56601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ann Mays, RN, CPN</last_name>
      <phone>605-312-6052</phone>
      <email>ann.mays@sanfordhealth.org</email>
    </contact>
    <investigator>
      <last_name>Kurt Griffin, PhD, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sanford Bismarck Region Clinics</name>
      <address>
        <city>Bismarck</city>
        <state>North Dakota</state>
        <zip>58501</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ann Mays, RN, CPN</last_name>
      <phone>605-312-6052</phone>
      <email>ann.mays@sanfordhealth.org</email>
    </contact>
    <investigator>
      <last_name>Kurt Griffin, PhD, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sanford Fargo Region Clinics</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ann Mays</last_name>
      <phone>605-312-6052</phone>
      <email>ann.mays@sanfordhealth.org</email>
    </contact>
    <investigator>
      <last_name>Kurt Griffin, PhD, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sanford Sioux Falls Region Clinics</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ann Mays</last_name>
      <phone>605-312-6052</phone>
      <email>ann.mays@sanfordhealth.org</email>
    </contact>
    <investigator>
      <last_name>Kurt Griffin, PhD, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sharon Hunt, BS, MS, MBA</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Candice Nelson, MD, FAAP</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stephanie Hanson, MD, FAAP</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Louis Casas, MD, FAAP</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Brenda Thurlow, MD, FAAP</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kyle Baum, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ann Mays, RN, CPN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://diabetesjournals.org/diabetes/article/71/4/610/144874/Screening-for-Type-1-Diabetes-in-the-General</url>
    <description>Sims et al.</description>
  </link>
  <reference>
    <citation>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.</citation>
    <PMID>35316839</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>March 7, 2023</last_update_submitted>
  <last_update_submitted_qc>March 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Population screening</keyword>
  <keyword>Type 1 Diabetes</keyword>
  <keyword>Celiac Disease</keyword>
  <keyword>Autoantibodies</keyword>
  <keyword>Prevention</keyword>
  <keyword>Diabetic Ketoacidosis (DKA)</keyword>
  <keyword>Genetic Risk Score</keyword>
  <keyword>Differential Gene Expression</keyword>
  <keyword>Economic Modeling</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Feasibility</keyword>
  <keyword>Pragmatic</keyword>
  <keyword>T1D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celiac Disease</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified patient characteristics, clinical and laboratory outcomes will be shared in an online platform.</ipd_description>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be available no later than 12 months after the conclusion of study.</ipd_time_frame>
    <ipd_access_criteria>Data available to researchers approved by investigators.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04477928
org study id: PLEDGE
nct id: NCT04477928
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
observational model: Other
time perspective: Prospective
measure: Demonstrated feasibility of large-scale population screening, as evidenced by:
time frame: By year 10 of the study
description: 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.
measure: Seroconversion rates for T1D-relevant and celiac autoantibodies
time frame: By year 10 of study
measure: Percentage of T1D seropositive subjects who enroll in another T1D monitoring or prevention study.
time frame: By year 10 of study
measure: Percentage of celiac seropositive subjects referred on to GI or primary care
time frame: By year 10 of study
measure: The percentage of celiac seropositive subjects who were evaluated in clinical setting
time frame: By year 10 of study
measure: The rate of development of overt hyperglycemia consistent with T1D (Stage 3).
time frame: By year 10 of study
measure: Proportion of participants developing overt hyperglycemia consistent with T1D (Stage 3), who present in diabetic ketoacidosis (DKA)
time frame: By year 10 of study
measure: Number and type of procedure-related adverse events
time frame: By year 10 of study
measure: 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
arm group label: Study Group
description: Children receiving routine care at a Sanford facility
intervention type: Diagnostic Test
intervention name: Sera and whole blood sampling
description: 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
arm group label: Study Group
intervention type: Diagnostic Test
intervention name: Differential Gene Expression (DGE)
description: Opt-in: Differential Gene Expression from cord blood at birth and peripheral blood at 12 months of age
arm group label: Study Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 0 Minutes
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kurt Griffin, PhD, MD
role: Principal Investigator
affiliation: Sanford Research
last name: Ann Mays, RN, CPN
phone: 605-312-6052
email: ann.mays@sanfordhealth.org
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
url: https://diabetesjournals.org/diabetes/article/71/4/610/144874/Screening-for-Type-1-Diabetes-in-the-General
description: Sims et al.
citation: 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.
PMID: 35316839
responsible party type: Sponsor
mesh term: Celiac Disease
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: Yes
ipd description: Deidentified patient characteristics, clinical and laboratory outcomes will be shared in an online platform.
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be available no later than 12 months after the conclusion of study.
ipd access criteria: Data available to researchers approved by investigators.