The role of SGLT-2 inhibitors (Empagliflozin) in treating steroid induced hyperglycaemia in the management of glucocorticoid induced hypoerglycaemia in adults with and without diabetes.

Phase 4

• Conditions: Steroid induced hyperglycaemia; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12620000745943
• Lead Sponsor: Endocrinology Department, Gosford Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-20
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion criteria
Informed consent
Adults aged 18 years old and older
Patients on Glucocorticoid therapy equivalent to 10mg prednisolone or more with planned duration of treatment for at
least 4 weeks
Patients without prior history of diabetes
Patients with pre-existing diabetes on single agent metformin therapy
2 blood glucose readings measuring more than 10mmol/L within a 24 hour period OR
1 random blood glucose reading measuring more than 15mmol/L

Exclusion Criteria

Renal impairment eGFR less than 45ml/minute
Poor oral intake or patient on a low carbohydrate or ketogenic diet
•Patient states that they are actively following a low carbohydrate diet which is
less than 130grams of carbohydrates a day

•Patient states that they are actively following a ketogenic diet which is 20-50grams of carbohydrates a day
Patient with active malignancy
History of recurrent genitourinary infections
Need for ICU admission at the time of recruitment
Current use of SGLT-2 inhibitors
Acute CVA in the past 2/12
Pregnancy/ Breast feeding
Volume depletion at the time of recruitment (gastroenteritis, acute kidney injury, fluid restriction of 1.5litres/day)
Inability to consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average time spent within target blood glucose range for each subject.<br>Each participant will email their blood glucose readings on a weekly basis.<br>Participants will be expected to monitor their blood glucose levels pre-breakfast and 2 hours post breakfast, lunch and dinner each day. Target blood glucose levels are pre-specified and each week the averages are taken for each pre and post breakfast, post lunch and post dinner readings to determine how many participants meet glycemic control while on empagliflozin therapy.[7 days post commencement of intervention]