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Recruiting NCT07676565

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

— Observational Type 1 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Type 1 Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Change in HbA1c by type of therapy [Time frame: 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 7 centers
  • Hoag Memorial Hospital — Newport Beach
  • Emory University — Atlanta
  • Northwestern University — Chicago
  • Maine Health Research Institute — Portland
  • Harvard Medical School — Boston
  • Henry Ford Hospital — Detroit
  • Mount Sinai — New York

Identifiers

NCT: NCT07676565 · 28772 · ATT1D

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗