NCT04629586

Brief Summary

The T1D Exchange Registry is a research study, conducted over time, for individuals with type 1 diabetes and their supporters. Participants volunteer to provide their data for research (for example, by answering questions in annual surveys). Once enrolled, Registry participants have the opportunity to sign up for other studies on various topics related to type 1 diabetes. To participate, you will be asked to:

  • Read and sign an online informed consent form
  • Take a survey describing specific demographic and type 1 diabetes management information
  • Update your information annually
  • Periodically opt in for additional research opportunities (if you choose), i.e. taking new surveys or uploading health device data

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress61%
Dec 2018Dec 2030

Study Start

First participant enrolled

December 13, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

May 8, 2023

Status Verified

May 1, 2023

Enrollment Period

12.1 years

First QC Date

October 22, 2020

Last Update Submit

May 4, 2023

Conditions

Keywords

insulint1ddmdiabetestype 1glucagon

Outcome Measures

Primary Outcomes (1)

  • Gather longitudinal data from individuals living with type 1 diabetes.

    Gather longitudinal data on disease, health status, and patient-reported outcomes of individuals living with type 1 diabetes. This will be achieved by presenting participants with annual questionnaires, tracking any changes in their responses over time.

    10 years

Study Arms (1)

Individuals diagnosed with type 1 diabetes

T1D Exchange Registry is currently looking for participants: * Of all ages, genders, races, and ethnic groups * Living in the United States * Diagnosed with type 1 diabetes * Currently taking insulin or have had a pancreatic or islet cell transplant

Other: No intervention

Interventions

Observational research study

Individuals diagnosed with type 1 diabetes

Eligibility Criteria

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

Individual diagnosed with type 1 diabetes who can access online Registry.

You may qualify if:

  • Clinical diagnosis of type 1 diabetes.
  • Individuals younger than 18 years of age must have parent/guardian consent.
  • Must be able to read and understand English.
  • Currently living in the United States

You may not qualify if:

  • Does not use insulin and has not had a pancreatic or islet cell transplant.
  • Cannot fully read and understand English.
  • Does not currently live in the United States.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

T1D Exchange

Boston, Massachusetts, 02111, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
50 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead Research Study Coordinator

Study Record Dates

First Submitted

October 22, 2020

First Posted

November 16, 2020

Study Start

December 13, 2018

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

May 8, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

The information collected in the study may be used in future studies without additional permission from you. This may include research done by other researchers. The information that may be shared will not contain any information that could identify you. There may still be a chance that someone could identify you, but this is not likely. The study results will also be made public. These results will not have any information that could identify you.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations