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

Diabetes Mellitus Clinical Trial

— IHUT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432275
• Other study ID #: ADC-PMS-INX-11011
• Status: Completed
• Phase: N/A
• First received: September 9, 2011
• Last updated: September 10, 2012
• Start date: September 2011
• Est. completion date: April 2012

Study information

• Verified date: September 2012
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Self monitoring blood glucose system
Use the comparator system for 7 days, then the InsuLinx system for 7 days in blood glucose mode only. Then 10 days using the InsuLinx system with insulin calculator.
• Self monitoring blood glucose system
Use the InsuLinx system for 7 days in blood glucose mode only, then use the comparator system for 7 days. Then 10 days using the InsuLinx with insulin calculator.

Locations

Country	Name	City	State
United Kingdom	Tameside Hospital NHS Foundation Trust	Ashton-under-Lyne
United Kingdom	Ayr Hospital	Ayr
United Kingdom	Royal United Hospital	Bath
United Kingdom	Royal Blackburn Hospital	Blackburn
United Kingdom	North Manchester Diabetes Centre	Crumpsall
United Kingdom	Ipswich Hospital NHS Trust	Ipswich
United Kingdom	Greenwood & Sneinton Family Medical Centre	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diabetes Care

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	User preference compared to current method		25 days	No
Secondary	User preference against comparison meters		25 days	No