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Real Life Evaluation of SGLT2 Use in Type 1 Diabetes — RESGUE1  

Diabetic Ketoacidosis Clinical Trial

Official title:
Real Life Evaluation of SGLT2 Use in Type 1 Diabetes

Clinical Trial Summary

The primary aim of the study is to prospectively monitor the risk of diabetic ketoacidosis (DKA) during treatment with sodium-glucose cotransporter 2 (SGLT2) inhibitors in type 1 diabetes after the treatment has become available as an adjunct therapy for people with type 1 diabetes.

Clinical Trial Description

SGLT2 inhibitors have recently been approved for treatment of type 1 diabetes. SGLT2 inhibitors affect renal glucose transport and promotes glucose excretion in the urine. This have attractive effects, notably by lowering of blood glucose without any increased risk of hypoglycemia as well as a reduction in body weight. Since the risk of hypoglycemia and weight gain during intensification of insulin treatment is a significant barrier for optimal glycemic control, SGLT2 inhibitors could be an attractive adjunct therapy in type 1 diabetes. Furthermore, SGLT2 inhibitors have beneficial cardiovascular and renal effects in persons with type 2 diabetes. This may also benefit persons with type 1 diabetes. However, the major limitation for an universal use of SGLT2 inhibitors in type 1 diabetes is a substantial increase in ketogenesis and the risk of DKA. DKA remain a substantial cause of morbidity and mortality in persons with type 1 diabetes. Since no data exist on the risk of DKA during SGLT2 inhibition outside the randomized controlled trials, the investigators will initiate a nationwide monitoring study on the use of SGLT2 inhibitors in type 1 diabetes. This will ensure follow-up on the efficacy, safety and patient-reported outcome measures for SGLT2 inhibitors treatment of type 1 diabetes in real-world clinical practice. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04819178
Study type Observational [Patient Registry]
Source Steno Diabetes Center Copenhagen
Contact
Status Withdrawn
Phase
Start date June 1, 2021
Completion date December 1, 2021
View Details
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