NCT04905823

Brief Summary

Given the high risk of severe SARS-CoV-2 infection, patients with T1D and T2D should represent a priority group to receive the SARS-CoV-2 vaccine. There are currently no studies on diabetic population response to mRNA COVID-19 vaccines. Therefore, in this observational cohort study, investigators will retrospectively analyze the safety and immunogenicity of the mRNA vaccines in eliciting both the humoral and cellular immune response in a subset of patients with T1D who already underwent blood sampling for measuring humoral response against SARSCoV2 for healthcare purposes and based on the clinical practice guidelines. Results will be compared with those obtained in non-diabetic individuals or in patients with non-autoimmune diabetes (T2D).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

May 24, 2021

Last Update Submit

May 9, 2023

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    number of adverse events after SARSCov2 vaccination

    change from baseline number at 2 months

Secondary Outcomes (3)

  • Humoral response

    change from baseline levels at 2 months

  • Immune cell response

    change from baseline levels at 2 months

  • Values of continuous glucose monitoring

    change from baseline values at 2 months

Study Arms (3)

Type 1 diabetes patients

Patients with type 1 diabetes

Diagnostic Test: blood test

Non-diabetic subjects

Subjects in whom diabetes has not been diagnosed

Diagnostic Test: blood test

Type 2 diabetes patients

Patients with type 2 diabetes

Diagnostic Test: blood test

Interventions

blood testDIAGNOSTIC_TEST

assessment of humoral, immune cell response and glycemia

Non-diabetic subjectsType 1 diabetes patientsType 2 diabetes patients

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with T1D, non-diabetic subjects and diabetic patients without T1D (T2D) who underwent blood sampling for testing levels of autoantibodies against SARSCoV2 after SARSCoV2 vaccination will be consecutively included in this retrospective study.

You may qualify if:

  • age \>16
  • History of type 1 diabetes
  • previous blood test in search for SARSCoV2 antibodies
  • willingness to provide informed consent

You may not qualify if:

  • age \<16 years
  • Systemic infections
  • Diabetic ketoacidosis in the past 6 weeks
  • COVID-19 diagnosis in the previous 6 months
  • age \>16
  • No previous history of diabetes
  • previous blood test in search for SARSCoV2 antibodies
  • willingness to provide informed consent
  • age \<16 years
  • Systemic infections
  • COVID-19 diagnosis in the previous 6 months
  • age \>16
  • History of type 2 diabetes but no evidence of autoantibodies
  • previous blood test in search for SARSCoV2 antibodies
  • willingness to provide informed consent
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST FBF-Sacco P.O. Sacco

Milan, MI, 20157, Italy

Location

Related Publications (1)

  • D'Addio F, Sabiu G, Usuelli V, Assi E, Abdelsalam A, Maestroni A, Seelam AJ, Ben Nasr M, Loretelli C, Mileto D, Rossi G, Pastore I, Montefusco L, Morpurgo PS, Plebani L, Rossi A, Chebat E, Bolla AM, Lunati ME, Mameli C, Macedoni M, Antinori S, Rusconi S, Gallieni M, Berra C, Folli F, Galli M, Gismondo MR, Zuccotti G, Fiorina P. Immunogenicity and Safety of SARS-CoV-2 mRNA Vaccines in a Cohort of Patients With Type 1 Diabetes. Diabetes. 2022 Aug 1;71(8):1800-1806. doi: 10.2337/db22-0053.

    PMID: 35551366DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Endocrinology, Chief of Endocrinology Division

Study Record Dates

First Submitted

May 24, 2021

First Posted

May 28, 2021

Study Start

March 31, 2021

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations

IT(1)