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.
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 Type
OBSERVATIONAL
Steno Diabetes Center Aarhus
Aarhus, Denmark
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark
Steno Diabetes Center Region Sjaelland
Køge, Denmark
Diabetic ketoacidosis
Registration of incidents of DKA will be done based on data from medical records, as well as reporting from patients and registries.
Time frame: 3 years
Efficacy of treatment
Data on HbA1c and total daily insulin dose will be registered from medical journals at baseline and each year at follow-up together with information on whether patients are still treated with SGLT2 inhibitors. Data on weight and hypoglycemia are obtained from patients.
Time frame: 3 years
Patient reported outcome
Patients will be asked to complete the questionnaire "PAID20" (Problem Areas In Diabetes), lowest score is 0, highest score is 80. The higher score the more emotionel reactions the person with type 1 diabetes has. The second questionaire is concernig incidense of being admittet to the hospital with ketoacidosis or hypoglycemia, whether the person with type 1 diabetes has expirienced side effects or weight loss efter initiation of treatment.
Time frame: 3 years
Side effects
Registration of incidence of urogenital infection will be done based on data from medical records, as well as reporting from patients and registries.
Time frame: 3 years
Hypoglyceamia
Registration of incidence of hypoglycemia will be done based on data from medical records, as well as reporting from patients and registries.
Time frame: 3 years
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