Evaluating Glucose Levels and Risk of Ketoacidosis in People with Type 1 Diabetes Receiving SGLT1/2 inhibitor Therapy Using a Novel Continuous Ketone Sensor; Exercise Sub-Study
- Conditions
- Type 1 DiabetesMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12624000992505
- Lead Sponsor
- St Vincent's Hospital Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 24
Age equal to or greater than 18 years; type 1 diabetes of more than 1 year duration; stable on insulin therapy; HbA1c <10.0%; access to a mobile phone compatible with the ketone monitoring system; willing to adhere to all requirements of the protocol including wearing and responding to information provided by the continuous ketone sensor for the duration of the study.
Pregnancy or planned pregnancy; eGFR<30 ml/minute/1.73m2; a history of diabetic ketoacidosis in the last 3 months; diabetic gastroparesis; tape allergy; unable to exercise; use of low carbohydrate diet; heavy alcohol use; major medical or psychiatric illness that in the opinion of the investigator would interfere with protocol adherence or impact participant safety.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be total % continuous ketone monitor (CKM) time spent >1.5 mmol/L from exercise onset until 24 hours post-exercise for each study arm.[Abbott Sensor-Based Ketone Monitoring System Exercise onset (T=0), to 24 hours post exercise (T=24)]
- Secondary Outcome Measures
Name Time Method