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

Abbott

Status

Completed

Conditions

Type 1 Diabetes

Treatments

Device: FreeStyle Freedom Lite

Device: FreeStyle InsuLinx

Study type

Interventional

Funder types

Industry

Identifiers

NCT01519466

ADC-PMR-INX-11012

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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