Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study

Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study

The purpose of this study is to investigate the effect of using FreeStyle InsuLinx (a blood glucose meter with a built-in insulin calculator) on glucose control in people with type 1 diabetes.

Inclusion Criteria:

• Subject with Type 1 diabetes on MDI (3 or more insulin injections per day (U100 insulin)) for at least 1 year and insulin adjusting
• HbA1c between 7.0% and 9.5% (53 to 80 mmol/mol) inclusive
• Age 18 and over
• In the investigator's opinion, thought technically capable of using masked CGM
• Subject self reporting a minimum of 21 SMBG tests per week prior to study enrolment
• Willing to perform a minimum of 4 SMBG tests per day during study

Exclusion Criteria:

• Subject has any concomitant disease or condition that, in the investigator's opinion, may compromise patient safety
• Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
• Subject is pregnant / planning to become pregnant within the planned study timeline
• Subject is known to require a dose of more than 50 units of U100 insulin in any one bolus injection
• Subject is currently on an insulin pump
• Subject is currently using the FreeStyle InsuLinx
• Subject is currently using the FreeStyle Freedom Lite
• Subject is currently using CGM
• Subject has an allergy to medical grade adhesives