Objective
The main objective of this study is to evaluate the safety and efficacy of adjunct therapies (weekly GLP-1RA and SGLTi) in adults with T1D. This study will generate data to inform clinical practice and future clinical trials for regulatory approval.
Background Rationale
Despite increasing use of such technologies, only 26% of adults with type 1 diabetes are able to achieve the recommended glycemic goal; i.e. HbA1c of less than 7%. Prevalence of obesity is increasing among adults with type 1 diabetes which leads to increased insulin requirements, increased risk for heart diseases and kidney problems. Therefore, there is a need to understand use of adjunctive medications such as GLP-1RA (like Ozempic or Mounjaro) and SGLTi types of drugs which may help to reduce weight, reduce insulin requirement and may make complement insulin delivery systems to improve diabetes outcomes. These drugs are not approved for managing type 1 diabetes and hence, we need data for future clinical trials and inform clinical practices to improve diabetes care and reduce diabetes complications.
Description of Project
Type 1 diabetes is characterized by autoimmune destruction of insulin producing beta cells. Insulin is the main stay of type 1 diabetes management. The last 10 years or so have witnessed good progress in development and utilization of diabetes technologies such as continuous glucose monitoring and automated insulin delivery system (also called hybrid closed-loop systems). Despite increasing use of such technologies, only 26% of adults with type 1 diabetes are able to achieve the recommended glycemic goal; i.e. HbA1c of less than 7%. Prevalence of obesity is increasing among adults with type 1 diabetes which leads to increased insulin requirements, increased risk for heart diseases and kidney problems. Therefore, there is a need to understand use of adjunctive medications such as GLP-1RA (like Ozempic or Mounjaro) and SGLTi types of drugs which may help to reduce weight, reduce insulin requirement and may make complement insulin delivery systems to improve diabetes outcomes. Currently, these molecules are not approved by the FDA due to lack of randomized trial or safety related concerns. We propose a registry study that can provide needed safety and efficacy evidence with adjunctive therapies to improve type 1 diabetes care. in this study, we will recruit participants who are prescribed with weekly GLP-1RA or SGLT-2i for any clinical indications from 20 centers across the United States. Participants will be followed for 1 year to evaluate safety and efficacy of adjunct therapies. We will evaluate changes in glycemic outcomes (such as A1c and time in range) and cardiovascular, kidney and liver outcomes over 1 year.
Anticipated Outcome
We expect that using adjunctive medications would improve glycemic control (HbA1c and time in range) without increase in time below range (hypoglycemia). We expect that these molecules would be safe to use in people with type 1 diabetes over 1 year.
Relevance to T1D
Two molecules, glucagon like peptide-1 receptor agonist (GLP-1RA) and sodium glucose cotransporter inhibitor (SGLT-2i) have changed the way we manage type 2 diabetes (T2D) now a days. Both classes of drugs have been shown to reduce cardiovascular events and mortality in people with T2D and people with obesity without diabetes. With increasing obesity and cardiovascular risk in people with type 1 diabetes, use of these agents is expected to increase. However, they are currently being used off-label as they are not approved by the FDA for managing T1D. Our real-world large observational study will provide much needed evidence on safety and potential efficacy of these molecules in adults with type 1 diabetes.