NCT07676565

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Mar 2026Apr 2028

Study Start

First participant enrolled

March 24, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

June 24, 2026

Last Update Submit

June 24, 2026

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c by type of therapy

    Change in HbA1c from baseline to over 1 year by those receiving GLP-1RA and SGLTi

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hoag Memorial Hospital

Newport Beach, California, 92663, United States

RECRUITING

Emory University

Atlanta, Georgia, 30303, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Maine Health Research Institute

Portland, Maine, 04102, United States

RECRUITING

Harvard Medical School

Boston, Massachusetts, 02115, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Kanchan Bhasin, MBBS

CONTACT

(317)-278-2752kanbhas@iu.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

June 24, 2026

First Posted

June 30, 2026

Study Start

March 24, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

June 30, 2026

Record last verified: 2026-06

Locations

US(7)