Safety and Efficacy of Adjunct Therapies in Adults With Type 1 Diabetes: Multicenter, Registry Study (ATT1D)

June 24, 2026 updated by: Viral N. Shah, Indiana University

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kanchan Bhasin, MBBS
  • Phone Number: (317)-278-2752
  • Email: kanbhas@iu.edu

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Memorial Hospital
        • Principal Investigator:
          • David Ahn, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Emory University
        • Principal Investigator:
          • Francisco Pasquel, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Grazia Aleppo, MD
        • Contact:
    • Maine
      • Portland, Maine, United States, 04102
        • Recruiting
        • Maine Health Research Institute
        • Contact:
        • Principal Investigator:
          • Jay Ambalavanan, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Harvard Medical School
        • Contact:
        • Principal Investigator:
          • Zeb Saeed, MD
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Davida Kruger, ANP
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai
        • Principal Investigator:
          • Carol Levy, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • No exclusion criteria other than those not meeting inclusion criteria above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Jaeb Center for Health Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

June 24, 2026

First Submitted That Met QC Criteria

June 24, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28772
  • ATT1D (Other Grant/Funding Number: Breakthrough T1D)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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