A Pilot Study Evaluating an Education Module Empowering People Living with Type 1 Diabetes to Understand their Continuous Glucose Monitoring Data: The Making Sense Program

St Vincent's Hospital Melbourne0 sites62 target enrollmentApril 19, 2023

Overview

No summary available.

Registry

who.int

Start Date

April 19, 2023

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

St Vincent's Hospital Melbourne

•T1D (diagnosis consistent with American Diabetes Association Classification of Diabetes Mellitus); Age \>18Y; HbA1c \<9\.5%; Fluent in English; using carbohydrate counting; \>3 months On MDI or insulin pump therapy (IPT) and safely operating a real time\-continuous glucose monitor (RT\-CGM) or intermittent scanning glucose monitor (ISGM) device; Willing and able to download and review device data; Living in an area with internet and cellular phone coverage; English speaking. Recruitment will be stratified approximately 1:1 MDI and IPT and at least 40% of all participants will be on either RT\-CGM or ISGM. At least 10 days of CGM data between screening and the baseline visit.

•Pregnant or planning pregnancy; Using open\-source artificial pancreas system (so\-called ‘do\-it\-yourself’ (DIY) technology); Use of any non\-insulin glucose\-lowering agent within the past 3 months; Oral or injected steroid use within the past 3 months; active significant nondiabetic illness impacting glucose management (e.g. coeliac disease, thyroid disease, myocardial ischaemia) or any severe or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the ability to meet protocol requirements.