Type 1 DiabetesNCT07155252
Home-based Oral Glucose Tolerance Test for Type 1 Diabetes Screening
An observational study of Type 1 Diabetes, run by Yale University at 1 site in United States.
Trial summary
This study aims at quantifying the accuracy of a self-administered fingerstick based glucose tolerance test (GTT@Home) respect to the gold-standard in-clinic venous plasma measures during the oral glucose tolerance test (OGTT) across a wide range of glycemic values in people at risk for clinical type 1 diabetes (T1D)… Read more about this study
- Who is it for?
- Ages 8 to 45 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- GTT@Home
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2025to Sep 2027
- 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 8 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A total of 60 participants will be enrolled at the Yale University Pediatric and Adult Diabetes Clinic (New Haven, CT). To ensure there is wide variation in glucose ranges with glucose tolerance testing a total of 3 cohorts will be recruited.
Who may be able to join
- Body weight ≥43 kg
- Presence of at least one islet autoantibody and/or≥ diagnosis of clinical T1D within 100 days.
- Documentation of the presence at least 1 islet autoantibody
- If participants meet ADA diagnostic criteria for Stage 3 type 1 diabetes, they will be eligible if the enrollment occurs within 100 days from the diagnosis and are at least 12 years old.
- Participants must be in good general health without other acute (e.g. infectious disease) febrile or chronic illnesses (e.g. uncontrolled asthma requiring high steroid doses, chronic arthritis) that in the judgment of the investigator could jeopardize participant safety or interfere with the study,
- Ability to give consent/assent
- Able to understand written and spoken English
Who cannot join
- Currently pregnant or becomes pregnant during the study
- Participants on sodium glucose cotransporter inhibitors (SGLTi).
- Donated blood in the past 8 weeks.
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
Yale University Pediatric and Adult Diabetes Clinic
New Haven, Connecticut, 06520
About this study
This study aims at quantifying the accuracy of a self-administered fingerstick based glucose tolerance test (GTT@Home) respect to the gold-standard in-clinic venous plasma measures during the oral glucose tolerance test (OGTT) across a wide range of glycemic values in people at risk for clinical type 1 diabetes (T1D) (carriers of at least one islet autoantibody) or with new onset Stage 3 T1D within 100 days from the diagnosis.
Read the detailed description
Investigators will conduct an observational longitudinal study that will include one home-based unsupervised GTT@Home test, a standard OGTT at a research facility and a supervised GTT@Home. Additionally, participants will have up to10-day blinded-CGM data collected.
- Conditions
- Type 1 Diabetes
- Being tested
- GTT@Home
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTT@HomeDiagnostic test
self-administered fingerstick based glucose tolerance test
| Study group | Role | What they receive |
|---|---|---|
| Single islet autoantibody | Participants with single islet autoantibody Receives: Diagnostic Test: GTT@Home | |
| 2 or more positive islet antibodies | Participants with 2 or more positive islet antibodies who are in (Stage 1) or (Stage 2) without dysglycemia Receives: Diagnostic Test: GTT@Home | |
| Recently diagnosed with diabetes | Participants meeting the diagnostic criteria for diabetes (stage 3 T1D) within 100 days from the diagnosis Receives: Diagnostic Test: GTT@Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of GTT@Home
The accuracy will be quantified by correlation between GTT@Home and OGTT glucose measures as well as by the mean absolute relative difference between the two measures.
Measured: up to 4 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start26 Aug 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Breakthrough T1D
- Responsible party
- Sponsor
- Investigators
- Jennifer Sherr, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155252
- Sponsor's protocol ID
- 2000040441
- Status last verified
- Mar 2026
- First submitted
- 26 Aug 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Oral Glucose Tolerance Test for Type 1 Diabetes Screening
- ClinicalTrials.gov ID
- NCT07155252
- Acronym / sponsor ID
- 2000040441
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Breakthrough T1D
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 4 Sep 2025 (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.
This study aims at quantifying the accuracy of a self-administered fingerstick based glucose tolerance test (GTT@Home) respect to the gold-standard in-clinic venous plasma measures during the oral glucose tolerance test (OGTT) across a wide range of glycemic values in people at risk for clinical type 1 diabetes (T1D) (carriers of at least one islet autoantibody) or with new onset Stage 3 T1D within 100 days from the diagnosis.
Detailed description
Investigators will conduct an observational longitudinal study that will include one home-based unsupervised GTT@Home test, a standard OGTT at a research facility and a supervised GTT@Home. Additionally, participants will have up to10-day blinded-CGM data collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single islet autoantibody | – | Diagnostic Test: GTT@HomeParticipants with single islet autoantibody |
| 2 or more positive islet antibodies | – | Diagnostic Test: GTT@HomeParticipants with 2 or more positive islet antibodies who are in (Stage 1) or (Stage 2) without dysglycemia |
| Recently diagnosed with diabetes | – | Diagnostic Test: GTT@HomeParticipants meeting the diagnostic criteria for diabetes (stage 3 T1D) within 100 days from the diagnosis |
Who may qualify
- Ages
- 8 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A total of 60 participants will be enrolled at the Yale University Pediatric and Adult Diabetes Clinic (New Haven, CT). To ensure there is wide variation in glucose ranges with glucose tolerance testing a total of 3 cohorts will be recruited.
Key inclusion criteria (7 listed)
- Body weight ≥43 kg
- Presence of at least one islet autoantibody and/or≥ diagnosis of clinical T1D within 100 days.
- Documentation of the presence at least 1 islet autoantibody
- If participants meet ADA diagnostic criteria for Stage 3 type 1 diabetes, they will be eligible if the enrollment occurs within 100 days from the diagnosis and are at least 12 years old.
- Participants must be in good general health without other acute (e.g. infectious disease) febrile or chronic illnesses (e.g. uncontrolled asthma requiring high steroid doses, chronic arthritis) that in the judgment of the investigator could jeopardize participant safety or interfere with the study,
Key exclusion criteria (3 listed)
- Currently pregnant or becomes pregnant during the study
- Participants on sodium glucose cotransporter inhibitors (SGLTi).
- Donated blood in the past 8 weeks.
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 |
|---|---|---|
| GTT@Homeself-administered fingerstick based glucose tolerance test | Diagnostic test | 2 or more positive islet antibodies, Recently diagnosed with diabetes, Single islet autoantibody |
Primary outcome
Accuracy of GTT@Home
Time frame: up to 4 weeks from enrollment
The accuracy will be quantified by correlation between GTT@Home and OGTT glucose measures as well as by the mean absolute relative difference between the two measures.
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 6 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Jennifer Sherr, MD principal investigator
Yale University
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 Type 1 Diabetes, run by Yale University 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 7 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 6 Mar 2026. 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 Marcia DeSousa, BA (203-737-4805, marcia.desousa@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of GTT@Home (time frame: up to 4 weeks from enrollment). 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 6 Mar 2026; AzTrials last refreshed its copy on 4 Nov 2026.