RECRUITING

General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery

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Conditions

Type 1 DiabetesCeliac DiseasePopulation screeningAutoantibodiesPreventionDiabetic Ketoacidosis (DKA)Genetic Risk ScoreDifferential Gene ExpressionEconomic ModelingQuality of LifeFeasibilityPragmaticT1D

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Sanford Population Level Estimation of Type 1 Diabetes Risk GEnes in Children

Quick Facts

Study Start:2020-07-17
Study Completion:2031-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04477928

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Minutes to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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.
  3. * 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.
  4. * Siblings of children known to have T1D-relevant antibodies; ages 6 to 17 years old who receive care at a Sanford clinic
  5. * Have an active MyChart account (with proxy access).
  1. * Subject is in the opinion of the investigator, unable to comply with the requirements of the study protocol.
  2. * Children known to have T1D

Contacts and Locations

Study Contact

Ann Mays, RN, CPN
CONTACT
605-312-6052
ann.mays@sanfordhealth.org

Principal Investigator

Kurt Griffin, PhD, MD
PRINCIPAL_INVESTIGATOR
Sanford Research

Study Locations (Sites)

Sanford Bemidji Region Clinics
Bemidji, Minnesota, 56601
United States
Sanford Bismarck Region Clinics
Bismarck, North Dakota, 58501
United States
Sanford Fargo Region Clinics
Fargo, North Dakota, 58112
United States
Sanford Sioux Falls Region Clinics
Sioux Falls, South Dakota, 57105
United States

Collaborators and Investigators

Sponsor: Sanford Health

  • Kurt Griffin, PhD, MD, PRINCIPAL_INVESTIGATOR, Sanford Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-17
Study Completion Date2031-03

Study Record Updates

Study Start Date2020-07-17
Study Completion Date2031-03

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Type 1 Diabetes
  • Celiac Disease