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Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care
ClinicalTrials.gov Identifier:
NCT01519466
First received: January 6, 2012
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to investigate the effect of using FreeStyle InsuLinx (a blood glucose meter with a built-in insulin calculator) on glucose control in people with type 1 diabetes.


Condition Intervention
Type 1 Diabetes
 Device: FreeStyle InsuLinx
Device: FreeStyle Freedom Lite

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Diabetes Care:

Primary Outcome Measures:
  • Change in time spent in euglycaemia [ Time Frame: Day 1-15 compared with Day 60-74 ] [ Designated as safety issue: No ]
    Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group.


Secondary Outcome Measures:
  • Change in time spent in euglycaemia [ Time Frame: Day 1-15 compared with Day 60-74 ] [ Designated as safety issue: No ]
    Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will compare the control and intervention groups using analysis of covariance to allow for differences at baseline.

  • Change in HbA1c [ Time Frame: Day 1 compared with Day 74 ] [ Designated as safety issue: No ]
    HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74). Analysis will assess the difference between the assessment and baseline results for the intervention group and compare the control and intervention groups.

  • Change in Total Daily Dose (TDD) of insulin [ Time Frame: 5-day diary data collected between Days 1-6 compared with 5-day diary data collected between Days 60-74. ] [ Designated as safety issue: No ]
    5-Day diary data collected during the first 2 weeks of the study will be compared to data collected during the last 2 weeks of the study. Analysis will assess the difference between the assessment and baseline TDD for the intervention group and compare the control and intervention groups.

  • Change in Patient Reported Outcome Measures [ Time Frame: Day 1 compared to Day 60 ] [ Designated as safety issue: No ]
    Diabetes Treatment Satisfaction Questionnaire (DTSQ), Hypoglycaemia Fear Survey (HFS)and Diabetes Distress Scale(DDS)Questionnaires will be completed at Baseline (Day 1) and visit 6 (approximately day 60)and the scores compared. Analysis will assess the difference between the assessment and baseline scores for the intervention group and compare the control and intervention groups.


Enrollment: 55
Study Start Date: January 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intervention
Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
 Device: FreeStyle InsuLinx
FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
Control
Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
 Device: FreeStyle Freedom Lite
FreeStyle Freedom Lite is a blood glucose meter

  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 diabetes on MDI (3 or more insulin injections per day (U100 insulin)) for at least 1 year and insulin adjusting
  • HbA1c between 7.0% and 9.5% (53 to 80 mmol/mol) inclusive
  • Age 18 and over
  • In the investigator's opinion, thought technically capable of using masked CGM
  • Subject self reporting a minimum of 21 SMBG tests per week prior to study enrolment
  • Willing to perform a minimum of 4 SMBG tests per day during study

Exclusion Criteria:

  • Subject has any concomitant disease or condition that, in the investigator's opinion, may compromise patient safety
  • Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
  • Subject is pregnant / planning to become pregnant within the planned study timeline
  • Subject is known to require a dose of more than 50 units of U100 insulin in any one bolus injection
  • Subject is currently on an insulin pump
  • Subject is currently using the FreeStyle InsuLinx
  • Subject is currently using the FreeStyle Freedom Lite
  • Subject is currently using CGM
  • Subject has an allergy to medical grade adhesives
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519466

Locations
Germany
Diabetes Zentrum Mergentheim
Bad Mergentheim, Germany, 97980
Diabetes-Zentrum für Kinder und Jugendliche
Hannover, Germany, 30173
Institut für Diabetes - Technology Forschungs - und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Germany, D-89081
Netherlands
VU University Medical Centre (VUMC)
Amsterdam, Netherlands, 1007 MB
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
Principal Investigator: Prof. Michaela Diamant VU University Medical Centre (VUMC)
  More Information

No publications provided

Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT01519466     History of Changes
Other Study ID Numbers: ADC-PMR-INX-11012
Study First Received: January 6, 2012
Last Updated: November 2, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Ethics Commission

Keywords provided by Abbott Diabetes Care:
Diabetes
SMBG
Insulin calculator

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013