Real Life Evaluation of SGLT2 Use in Type 1 Diabetes

Withdrawn

• Conditions: Diabetic Ketoacidosis

• Registration Number: NCT04819178
• Lead Sponsor: Steno Diabetes Center Copenhagen

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.

Study Timeline

• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-26
• Study Start: 2021-06-01
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-10
• Last Update Posted: 2022-02-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diabetic ketoacidosis	3 years	Registration of incidents of DKA will be done based on data from medical records, as well as reporting from patients and registries.

Secondary Outcome Measures

Name	Time	Method
Side effects	3 years	Registration of incidence of urogenital infection will be done based on data from medical records, as well as reporting from patients and registries.
Efficacy of treatment	3 years	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.
Patient reported outcome	3 years	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.
Hypoglyceamia	3 years	Registration of incidence of hypoglycemia will be done based on data from medical records, as well as reporting from patients and registries.

Trial Locations

Locations (3)

Steno Diabetes Center Copenhagen; 🇩🇰 Gentofte, Denmark

Steno Diabetes Center Region Sjaelland; 🇩🇰 Køge, Denmark

Steno Diabetes Center Aarhus; 🇩🇰 Aarhus, Denmark