Type 1 DiabetesATT1DNCT07676565
Safety and Efficacy of Adjunct Therapies in Adults With Type 1 Diabetes: Multicenter, Registry Study
An observational study of Type 1 Diabetes, run by Indiana University at 17 sites in United States.
Trial summary
This will be a multicenter registry-based study to evaluate safety and efficacy of GLP-1RA and SGLTi therapies in adjunct to insulin in adults with type 1 diabetes (T1D) over 1 year. This study will enroll participants who have been prescribed adjunct therapy as part of usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 300 participants
- Where
- 17 sitesUnited States
- Study dates
- 24 Mar 2026to Apr 2028
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with type 1 diabetes who have been prescribed an adjunctive medications (GLP-1RA or SGLTi) as a part of their clinical care by their health care providers.
Who may be able to join
- Adults ≥18 years of age
- Clinical diagnosis of T1D
- GLP-1RA or SGLTi (SGLT-1 and SGLT-2 inhibitors) drug prescribed by their provider for any indication as part of usual care with use for no more than 1 week
- Use of CGM and availability of CGM data for 1 month prior to enrollment and expected to be available throughout the study
- Willing and able to provide informed consent
Who cannot join
- No exclusion criteria other than those not meeting inclusion criteria above
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites, 17 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30303
sabeena usman, 404-251-8959, sabeena.usman@emory.edu
Francisco Pasquel, MD
- Recruiting
Harvard Medical School
Boston, Massachusetts, 02115
Grace Ordonez, 617-732-4245, gordonez@bwh.harvard.edu
Zeb Saeed, MD
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Evelyn Fronczyk, 312-908-9002, evelyn.guevara@northwestern.edu
Grazia Aleppo, MD
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
Alyssa Randolph, 513-558-3427, randolas@ucmail.uc.edu
Andrew Welch, DO
- Recruiting
Ohio State University
Columbus, Ohio, 43203
Aleitha Gates, 614-814-0771, aleitha.gates@osumc.edu
Kathleen Dungan, MD
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Lydia Oehring, 313-916-3906, loehrin1@hfhs.org
Davida Kruger, ANP
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Tiffanie Shelburne, 502-852-1411, tiffanie.shelburne@louisville.edu
Sathya S. Krishnasamy, M.D.
- Recruiting
University of Miami
Miami, Florida, 33136
Julia Martins de Oliveira, 305-243-3466, Jmd636@miami.edu
Francesco Vendrame, MD, PhD
- Recruiting
HealthPartners, International Diabetes Center
Minneapolis, Minnesota, 55416
Caitlin M. Moening, 952-993-9605, caitlin.m.moening@healthpartners.com
Anders L. Carlson, MD
- Recruiting
NYU Grossman School of Medicine
New York, New York, 10016
Zoe Rimler, 212-263-2544, Zoe.Rimler@nyulangone.org
Mollie O'Connor, MD
- Recruiting
Mount Sinai
New York, New York, 10029
Sophie Baun, 212-241-4301, sophie.baum@mssm.edu
Carol Levy, MD
- Recruiting
Hoag Memorial Hospital
Newport Beach, California, 92663
Brittany Dennis, 949-764-6896, Brittany.Dennis@hoag.org
David Ahn, MD
- Recruiting
Eastern Virginia Medical Center, Old Dominion University
Norfolk, Virginia, 23510
Shayreen Gomez Ocasio, 757-446-8485, socasiog@odu.edu
Manasi S. Shah, MD
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Reagan TeKolste, 402-552-9662, rtekolste@unmc.edu
Shubham Agarwal, MD
- Recruiting
Maine Health Research Institute
Portland, Maine, 04102
Debra Burris, 207-662-2467, debra.burris@mainehealth.org
Jay Ambalavanan, MD
- Recruiting
University of Rochester
Rochester, New York, 14642
Samantha DelMartino, 585-273-3877, Samantha_delmartino@urmc.rochester.edu
Sara R. MacLeod, DO, MPH
- Recruiting
University of California, San Francisco (UCSF)
San Francisco, California, 94158
Nicole Sears, 628-278-8760, nicole.sears@ucsf.edu
Laya Ekhlaspour, MD
About this study
Official title: Safety and Efficacy of Adjunct Therapies in Adults With Type 1diabetes: Multicenter, Registry Study
This will be a multicenter registry-based study to evaluate safety and efficacy of GLP-1RA and SGLTi therapies in adjunct to insulin in adults with type 1 diabetes (T1D) over 1 year. This study will enroll participants who have been prescribed adjunct therapy as part of usual care.
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, GLP1-RA, SGLT2i
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c by type of therapy
Change in HbA1c from baseline to over 1 year by those receiving GLP-1RA and SGLTi
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start24 Mar 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (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 Indiana 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
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Jaeb Center for Health Research
- Responsible party
- Principal investigator, Viral N. Shah, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676565
- Sponsor's protocol ID
- 28772
- Other IDs
- ATT1D
- Acronym
- ATT1D
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Adjunct Therapies in Adults With Type 1diabetes: Multicenter, Registry Study
- ClinicalTrials.gov ID
- NCT07676565
- Acronym / sponsor ID
- ATT1D / 28772
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, GLP1-RA, SGLT2i
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Jaeb Center for Health Research
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 30 Jun 2026 (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 will be a multicenter registry-based study to evaluate safety and efficacy of GLP-1RA and SGLTi therapies in adjunct to insulin in adults with type 1 diabetes (T1D) over 1 year. This study will enroll participants who have been prescribed adjunct therapy as part of usual care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with type 1 diabetes who have been prescribed an adjunctive medications (GLP-1RA or SGLTi) as a part of their clinical care by their health care providers.
Key inclusion criteria (5 listed)
- Adults ≥18 years of age
- Clinical diagnosis of T1D
- GLP-1RA or SGLTi (SGLT-1 and SGLT-2 inhibitors) drug prescribed by their provider for any indication as part of usual care with use for no more than 1 week
- Use of CGM and availability of CGM data for 1 month prior to enrollment and expected to be available throughout the study
- Willing and able to provide informed consent
Key exclusion criteria (1 listed)
- No exclusion criteria other than those not meeting inclusion criteria above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in HbA1c by type of therapy
Time frame: 1 year
Change in HbA1c from baseline to over 1 year by those receiving GLP-1RA and SGLTi
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 16 Oct 2026.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
17 sites 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 Indiana University at 17 sites 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 5 inclusion and 1 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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 Kanchan Bhasin, MBBS, MS ((317)-278-2752, kanbhas@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c by type of therapy (time frame: 1 year). 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 16 Oct 2026.