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

April 27, 2017 updated by: Abbott Diabetes Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Ashton-under-Lyne, United Kingdom, OL6 9RW
        • Tameside Hospital NHS Foundation Trust
      • Ayr, United Kingdom, KA6 6DX
        • Ayr Hospital
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospital
      • Blackburn, United Kingdom, BB2 7PL
        • Royal Blackburn Hospital
      • Crumpsall, United Kingdom, M8 5RB
        • North Manchester Diabetes Centre
      • Ipswich, United Kingdom, IP4 5PD
        • Ipswich Hospital NHS Trust
      • Nottingham, United Kingdom, NG3 7DQ
        • Greenwood & Sneinton Family Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADC, Then Comparator, Then ADC With Calculator
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.
Device: ADC blood glucose meter
Subjects used the FreeStyle InsuLinx with the insulin calculator not activated. Subjects had not previously used the FreeStyle InsuLinx meter.
Other Names:
  • Abbott Freestyle InsuLinx
Device: Comparator blood glucose meter
Subjects were randomly assigned one of the comparator meters. Subjects had not previously used the assigned comparator meter.
Other Names:
  • Roche Accu-Chek Aviva Nano
  • Lifescan Verio Pro or
  • Bayer Contour USB
Device: ADC blood glucose meter with insulin calculator active
Subjects used the FreeStyle InsuLinx with the insulin calculator activated.
Other Names:
  • Abbott FreeStyle InsuLinx
Experimental: Comparator, Then ADC, Then ADC With Calculator
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.
Device: ADC blood glucose meter
Subjects used the FreeStyle InsuLinx with the insulin calculator not activated. Subjects had not previously used the FreeStyle InsuLinx meter.
Other Names:
  • Abbott Freestyle InsuLinx
Device: Comparator blood glucose meter
Subjects were randomly assigned one of the comparator meters. Subjects had not previously used the assigned comparator meter.
Other Names:
  • Roche Accu-Chek Aviva Nano
  • Lifescan Verio Pro or
  • Bayer Contour USB
Device: ADC blood glucose meter with insulin calculator active
Subjects used the FreeStyle InsuLinx with the insulin calculator activated.
Other Names:
  • Abbott FreeStyle InsuLinx

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Diabetes Care

Investigators

  • Principal Investigator: Shenaz Ramtoola, Royal Blackburn Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 9, 2011

First Submitted That Met QC Criteria

September 9, 2011

First Posted (Estimate)

September 12, 2011

Study Record Updates

Last Update Posted (Actual)

August 4, 2017

Last Update Submitted That Met QC Criteria

April 27, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADC-PMS-INX-11011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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