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

Type 1 Diabetes Clinical Trial

— PLEDGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04477928
• Other study ID #: PLEDGE
• Status: Recruiting
• Start date: July 17, 2020
• Est. completion date: March 2031

Study information

• Verified date: April 2024
• Source: Sanford Health
• Contact: Ann Mays, RN, CPN
• Phone: 605-312-6052
• Email: ann.mays[@]sanfordhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33000
• Est. completion date: March 2031
• Est. primary completion date: March 2031
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Minutes to 17 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• Subject is in the opinion of the investigator, unable to comply with the requirements of the study protocol.

• Children known to have T1D

Related Conditions & MeSH terms

• Celiac Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Diagnostic Test:
• 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
• Differential Gene Expression (DGE)
Opt-in: Differential Gene Expression from cord blood at birth and peripheral blood at 12 months of age

Locations

Country	Name	City	State
United States	Sanford Bemidji Region Clinics	Bemidji	Minnesota
United States	Sanford Bismarck Region Clinics	Bismarck	North Dakota
United States	Sanford Fargo Region Clinics	Fargo	North Dakota
United States	Sanford Sioux Falls Region Clinics	Sioux Falls	South Dakota

Sponsors (4)

Lead Sponsor	Collaborator
Sanford Health	Pacific Northwest Research Institute, The Leona M. and Harry B. Helmsley Charitable Trust, University of Exeter

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	By year 10 of the study
Secondary	Seroconversion rates for T1D-relevant and celiac autoantibodies		By year 10 of study
Secondary	Percentage of T1D seropositive subjects who enroll in another T1D monitoring or prevention study.		By year 10 of study
Secondary	Percentage of celiac seropositive subjects referred on to GI or primary care		By year 10 of study
Secondary	The percentage of celiac seropositive subjects who were evaluated in clinical setting		By year 10 of study
Secondary	The rate of development of overt hyperglycemia consistent with T1D (Stage 3).		By year 10 of study
Secondary	Proportion of participants developing overt hyperglycemia consistent with T1D (Stage 3), who present in diabetic ketoacidosis (DKA)		By year 10 of study
Secondary	Number and type of procedure-related adverse events		By year 10 of study
Secondary	Assessment of costs associated with implementation of study compared to potential impacts on cost and quality of life.		By year 10 of study

External Links

•   Sims et al.