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

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ClinicalTrials.gov Identifier: NCT01432275
Recruitment Status : Completed
First Posted : September 12, 2011
Results First Posted : August 4, 2017
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: ADC blood glucose meter Device: Comparator blood glucose meter Device: ADC blood glucose meter with insulin calculator active Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Ease of Use of New Blood Glucose Meter With In-built Insulin Calculator at Home Study
Study Start Date : September 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: Abbott FreeStyle InsuLinx


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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"


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432275


Locations
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United Kingdom
Tameside Hospital NHS Foundation Trust
Ashton-under-Lyne, United Kingdom, OL6 9RW
Ayr Hospital
Ayr, United Kingdom, KA6 6DX
Royal United Hospital
Bath, United Kingdom, BA1 3NG
Royal Blackburn Hospital
Blackburn, United Kingdom, BB2 7PL
North Manchester Diabetes Centre
Crumpsall, United Kingdom, M8 5RB
Ipswich Hospital NHS Trust
Ipswich, United Kingdom, IP4 5PD
Greenwood & Sneinton Family Medical Centre
Nottingham, United Kingdom, NG3 7DQ
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
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Principal Investigator: Shenaz Ramtoola Royal Blackburn Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT01432275    
Other Study ID Numbers: ADC-PMS-INX-11011
First Posted: September 12, 2011    Key Record Dates
Results First Posted: August 4, 2017
Last Update Posted: August 4, 2017
Last Verified: April 2017
Keywords provided by Abbott Diabetes Care:
Diabetes
SMBG
Insulin calculator
Additional relevant MeSH terms:
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Insulin
Hypoglycemic Agents
Physiological Effects of Drugs