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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIndiana University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

No exclusion criteria other than those not meeting inclusion criteria above

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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Indiana University

Lead sponsor

Jaeb Center for Health Research

Collaborator