Ease of Use of New Blood Glucose Meter With In-built Insulin Calculator at Home Study (IHUT)

Abbott

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: ADC blood glucose meter with insulin calculator active; Device: ADC blood glucose meter; Device: Comparator blood glucose meter

Study type: Interventional

Funder types: Industry

Identifiers

NCT01432275

ADC-PMS-INX-11011

Details and patient eligibility

About

The aim of this study is to evaluate user preference and ease of use of the FreeStyle InsuLinx system, compared to current methodology, when used at home by subjects with diabetes.

Subjects will also be comparing the ease of use of the FreeStyle InsuLinx system with comparator meters.

Enrollment: 179 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject with Type 1 or 2 diabetes on a bolus regime (U100 insulin), one or more bolus injections per day for at least 6 months;
• Age 18 yrs and above;
• Regularly testing SMBG 3 or more times per day;
• Willingness to test at least 4 times per day.

Exclusion criteria

• Know to require a bolus injection of more than 50U in a single dose;
• Has previously used either the InsuLinx or assigned comparison meter;
• Participated in structured diabetes management training in the last 6 months
• Is currently on an insulin pump;
• Has concomitant disease that, in the Investigator's opinion, may compromise patient safety;
• Is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management;
• Female subject who is pregnant or planning to become pregnant during the course of the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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179 participants in 2 patient groups

ADC, Then Comparator, Then ADC With Calculator

Experimental group

Description:

Subject used the ADC blood glucose meter for 7 days with the insulin calculator not activated, followed by a comparator blood glucose meter for 7 days. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.

Treatment:

Device: Comparator blood glucose meter

Device: ADC blood glucose meter

Device: ADC blood glucose meter with insulin calculator active

Comparator, Then ADC, Then ADC With Calculator

Experimental group

Description:

Subject used a comparator blood glucose meter for 7 days, followed by the ADC blood glucose meter for 7 days, with the insulin calculator not activated. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.

Treatment:

Device: Comparator blood glucose meter

Device: ADC blood glucose meter

Device: ADC blood glucose meter with insulin calculator active