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The T1D Exchange Registry (T1D Registry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04629586
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Kelsie LaFerriere, T1D Exchange, United States

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
Diabetes Mellitus, Type 1 Diabetes Type 1 Diabetes Diabetes Mellitus Other: No intervention

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 50 Years
Official Title: The T1D Exchange Registry
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : December 31, 2030
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort 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




Primary Outcome Measures :
  1. Gather longitudinal data from individuals living with type 1 diabetes. [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individual diagnosed with type 1 diabetes who can access online Registry.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04629586


Contacts
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Contact: Carolina Leon (617) 892-0429 cleon@t1dexchange.org
Contact: Kelsie LaFerriere (617) 892-9941 klaferriere@t1dexchange.org

Locations
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United States, Massachusetts
T1D Exchange Recruiting
Boston, Massachusetts, United States, 02111
Contact: Carolina Leon    617-892-0429    cleon@t1dexchange.org   
Sponsors and Collaborators
T1D Exchange, United States
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Responsible Party: Kelsie LaFerriere, Lead Research Study Coordinator, T1D Exchange, United States
ClinicalTrials.gov Identifier: NCT04629586    
Other Study ID Numbers: 1822333
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kelsie LaFerriere, T1D Exchange, United States:
insulin
t1d
dm
diabetes
type 1
glucagon
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases