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

NCT07676565 · Indiana University
In plain English

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Official title
Safety and Efficacy of Adjunct Therapies in Adults With Type 1diabetes: Multicenter, Registry Study
About this 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.
Eligibility criteria
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 design
Enrollment target: 300 participants
Age groups: adult, older_adult
Timeline
Starts: 2026-03-24
Estimated completion: 2028-04
Last updated: 2026-06-30
Primary outcomes
  • Change in HbA1c by type of therapy (1 year)
Sponsor
Indiana University · other
With: Jaeb Center for Health Research
Contacts & investigators
ContactKanchan Bhasin, MBBS · contact · kanbhas@iu.edu · (317)-278-2752
All locations (7)
Hoag Memorial HospitalRecruiting
Newport Beach, California, United States
Emory UniversityRecruiting
Atlanta, Georgia, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Maine Health Research InstituteRecruiting
Portland, Maine, United States
Harvard Medical SchoolRecruiting
Boston, Massachusetts, United States
Henry Ford HospitalRecruiting
Detroit, Michigan, United States
Mount SinaiRecruiting
New York, New York, United States
Safety and Efficacy of Adjunct Therapies in Adults With Type 1 Diabetes: Multicenter, Registry Study · TrialPath