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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: ADC blood glucose meter; Device: Comparator blood glucose meter; Device: ADC blood glucose meter with insulin calculator active

• Registration Number: NCT01432275
• Lead Sponsor: Abbott Diabetes Care

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-09
• Study First Submitted QC: 2011-09-09
• Study First Posted: 2011-09-12
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2013-07-10
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-27
• Last Update Submitted: 2017-04-27
• Results First Posted: 2017-08-04
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Comparator, Then ADC, Then ADC With Calculator	ADC blood glucose meter	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.
ADC, Then Comparator, Then ADC With Calculator	ADC blood glucose meter with insulin calculator active	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.
Comparator, Then ADC, Then ADC With Calculator	ADC blood glucose meter with insulin calculator active	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.
ADC, Then Comparator, Then ADC With Calculator	ADC blood glucose meter	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.
ADC, Then Comparator, Then ADC With Calculator	Comparator blood glucose meter	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.
Comparator, Then ADC, Then ADC With Calculator	Comparator blood glucose meter	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.

Primary Outcome Measures

Name	Time	Method
Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method.	25 days	Overall user preference of the FreeStyle InsuLinx system as a diabetes management tool when compared against their usual method.

Secondary Outcome Measures

Name	Time	Method
Preference Questionnaire (Insulin Calculator Not Activated)	25 days (results recorded after the two 7 day periods)	Result for the question: "The meter the subject would change to"

Trial Locations

Locations (7)

Tameside Hospital NHS Foundation Trust; 🇬🇧 Ashton-under-Lyne, United Kingdom

Royal United Hospital; 🇬🇧 Bath, United Kingdom

Royal Blackburn Hospital; 🇬🇧 Blackburn, United Kingdom

North Manchester Diabetes Centre; 🇬🇧 Crumpsall, United Kingdom

Greenwood & Sneinton Family Medical Centre; 🇬🇧 Nottingham, United Kingdom

Ayr Hospital; 🇬🇧 Ayr, United Kingdom

Ipswich Hospital NHS Trust; 🇬🇧 Ipswich, United Kingdom