Clinical trial NCT04819178: Real Life Evaluation of SGLT2 Use in Type 1 Diabetes
Official title: Real Life Evaluation of SGLT2 Use in Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetic Ketoacidosis
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with type 1 diabetes initiated on SGLT2 inhibition will be prospectively included after provision of informed consent. We have established a national network of centers and investigators involved in the treatment of type 1 diabetes. We aim to offer inclusion in the study to every individual where SGLT2 inhibitor treatment is planned

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* All patiens with type 1 diabetes on SGLT2 inhibitor treatment or where this treatment is planned.

Exclusion Criteria:

* None

Primary outcomes:
measure: Diabetic ketoacidosis
timeFrame: 3 years
Secondary outcomes:
measure: Efficacy of treatment
timeFrame: 3 years
measure: Patient reported outcome
timeFrame: 3 years
measure: Side effects
timeFrame: 3 years
measure: Hypoglyceamia
timeFrame: 3 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Steno Diabetes Center Aarhus
city: Gentofte
country: Denmark
facility: Steno Diabetes Center Copenhagen
city: Køge
country: Denmark
facility: Steno Diabetes Center Region Sjaelland
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Frederik Persson, MD, DMsc
role: PRINCIPAL_INVESTIGATOR
References: