Real Life Evaluation of SGLT2 Use in Type 1 Diabetes (RESGUE1)

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetic Ketoacidosis

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 Type: Observational

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Steno Diabetes Center Aarhus
  • Gentofte, Denmark, 2820
    • Steno Diabetes Center Copenhagen
  • Køge, Denmark, 4600
    • Steno Diabetes Center Region Sjaelland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	3 years

Collaborators and Investigators

• Sponsor: Steno Diabetes Center Copenhagen
• Investigators: Principal Investigator: Frederik Persson, MD, DMsc, Steno Diabetes Center Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Acid-Base Imbalance; Acidosis; Ketosis; Diabetic Ketoacidosis
• Other Study ID Numbers: 22436292