T1D Registry: The T1D Exchange Registry

• Sponsor: T1D Exchange, United States (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04629586
• Collaborator: (none)
• Enrollment: 50,000
• Location: 1
• Anticipated Duration (Months): 144.6
• Patients Per Site Per Month: 345.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1; Diabetes; Type 1 Diabetes; Diabetes Mellitus	Other: No intervention

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 50000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The T1D Exchange Registry
• Actual Study Start Date: Dec 13, 2018
• Anticipated Primary Completion Date: Dec 31, 2030
• Anticipated Study Completion Date: Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
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; Observational research study

Outcome Measures

Primary Outcome Measures

1. Gather longitudinal data from individuals living with type 1 diabetes. [10 years]

   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 an annual questionnaires, tracking any changes in their responses over time.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	T1D Exchange	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

• T1D Exchange, United States

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kelsie LaFerriere, Lead Research Study Coordinator, T1D Exchange, United States
• ClinicalTrials.gov Identifier: NCT04629586
• Other Study ID Numbers: 1822333
• First Posted: Nov 16, 2020
• Last Update Posted: Nov 16, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kelsie LaFerriere, Lead Research Study Coordinator, T1D Exchange, United States: insulin; t1d; dm; diabetes; type 1; glucagon
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Nov 16, 2020