A Pilot Study Evaluating Continuous Glucose Monitoring (CGM)-User Education for Type 1 Diabetes

Not Applicable

• Conditions: Type 1 Diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12623000395639
• Lead Sponsor: St Vincent's Hospital Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-19
• Last Update Posted: 24 April 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of the number of participants (n=62) who complete the study per-protocol. This will be assessed using data from the online education platform, and the study database. [Assessed at the conclusion of the study. ]