Diabetes Mellitus, Type 1T1D RegistryNCT04629586
The T1D Exchange Registry
An observational study of Diabetes Mellitus, Type 1 and Diabetes, run by T1D Exchange, United States at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes, Type 1 Diabetes
- How many people
- 50,000 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2018to 31 Dec 2030
- How long will I take part?
- 50 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individual diagnosed with type 1 diabetes who can access online Registry.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
T1D Exchange
Boston, Massachusetts, 02111
Kelsie LaFerriere, 617-892-9941, klaferriere@t1dexchange.org
About this study
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
- Being tested
- No intervention
- Keywords
- insulin, t1d, dm, diabetes, type 1, glucagon
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational research study
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start13 Dec 2018
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
- Target duration
- 50 Years
Sponsor and investigators
- Lead sponsor
- T1D Exchange, United States
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelsie LaFerriere, T1D Exchange, United States
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629586
- Sponsor's protocol ID
- 1822333
- Acronym
- T1D Registry
- Status last verified
- May 2023
- First submitted
- 22 Oct 2020
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The T1D Exchange Registry
- ClinicalTrials.gov ID
- NCT04629586
- Acronym / sponsor ID
- T1D Registry / 1822333
- Keywords
- insulin, t1d, dm, diabetes, type 1, glucagon
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- T1D Exchange, United StatesUniversity, hospital or other
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 50 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals diagnosed with type 1 diabetes | – | Other: No interventionT1D 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individual diagnosed with type 1 diabetes who can access online Registry.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionObservational research study | Other | Individuals diagnosed with type 1 diabetes |
Primary outcome
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 annual questionnaires, tracking any changes in their responses over time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Diabetes, run by T1D Exchange, United States at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelsie LaFerrier ((617) 892-9941, klaferriere@t1dexchange.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gather longitudinal data from individuals living with type 1 diabetes. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.