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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care
ClinicalTrials.gov Identifier:
NCT01432275
First received: September 9, 2011
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention
Diabetes Mellitus
 Device: Self monitoring blood glucose system

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Ease of Use of New Blood Glucose Meter With In-built Insulin Calculator at Home Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Diabetes Care:

Primary Outcome Measures:
  • User preference compared to current method [ Time Frame: 25 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • User preference against comparison meters [ Time Frame: 25 days ] [ Designated as safety issue: No ]

Enrollment: 179
Study Start Date: September 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Comparator, ADC, ADC with calculator
Subject uses 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 uses the ADC blood glucose meter with insulin calculator activated for 10 days
 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.
Other Names:
  • Abbott Freestyle InsuLinx
  • Roche Accu-Chek Aviva Nano
  • Lifescan Verio Pro
  • Bayer Contour USB
ADC, comparator, ADC with calculator
Subject 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 uses the ADC blood glucose meter with insulin calculator activated for 10 days
 Device: 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.
Other Names:
  • Freestyle InsuLinx
  • Roche Accu-Chek Aviva Nano
  • Lifescan Verio Pro or
  • Bayer Contour USB

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432275

Locations
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
Principal Investigator: Shenaz Ramtoola Royal Blackburn Hospital
  More Information

No publications provided

Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT01432275     History of Changes
Other Study ID Numbers: ADC-PMS-INX-11011
Study First Received: September 9, 2011
Last Updated: September 10, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Abbott Diabetes Care:
Diabetes
SMBG
Insulin calculator

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013