The Partner Study in people with Type 1 Diabetes

Aim of study

This research study will evaluate a drug called sotagliflozin, which may improve glucose levels, protect the kidneys and heart, and offer the potential for weight loss. However, sotagliflozin use in type 1 diabetes (T1D) can be associated with diabetic ketoacidosis (DKA).

The aim of this study is to monitor glucose and ketone levels concurrently utilising continuous glucose and ketone sensors, combined with an education program to reduce the risk of DKA.
This study will aid in the prevention of DKA and potentially allow for the use of this drug in T1D.

Who can participate?

Inclusion criteria:

• Over 18 years old
• T1D of over 1 year duration
• • stable on insulin therapy
• HbA1c <10.0%
• access to a mobile phone compatible with the FreeStyle Libre 2 continuous glucose monitor
• 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.

Exclusion criteria:

• Pregnancy or planned pregnancy
• eGFR (estimated glomerular filtration rate) <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, (<100g carbohydrates per day)
• heavy alcohol use
• major medical or psychiatric illness that could interfere with protocol adherence or impact participant safety.

Participation in this study will involve:

• 30 weeks participation
• 6-8 on-site clinic visits (to St Vincent’s Hospital, Fitzroy)
• Wearing 2 sensors on the body monitored continuously via phone apps.

This project has received ethical approval from the St Vincent’s Hospital Melbourne Human Research Ethics Committee HREC Reference: 302/23

The Diabetes Technology Research Group

For further information and contact details, click here.