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Completed

NCT Number: NCT01432275

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ADC blood glucose meter

Device

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

Comparator blood glucose meter

Device

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

ADC blood glucose meter with insulin calculator active

Device

Subjects used the FreeStyle InsuLinx with the insulin calculator activated.

Other names: Abbott FreeStyle InsuLinx

Primary outcomes

  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 outcomes

  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"

Sponsors and collaborators

Lead sponsor

Abbott Diabetes Care

Industry

Registry information

Acronym: IHUT

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 12, 2011
Registry last updated
Aug 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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