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

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ClinicalTrials.gov Identifier: NCT01519466
Recruitment Status : Completed
First Posted : January 27, 2012
Results First Posted : April 1, 2016
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care

Tracking Information
First Submitted Date  ICMJE January 6, 2012
First Posted Date  ICMJE January 27, 2012
Results First Submitted Date  ICMJE November 12, 2015
Results First Posted Date  ICMJE April 1, 2016
Last Update Posted Date April 1, 2016
Study Start Date  ICMJE January 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2016)
Time in Target Blood Glucose Range [ Time Frame: Day 1-15 compared with Day 60-74 ]
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. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL)
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2012)
Change in time spent in euglycaemia [ Time Frame: Day 1-15 compared with Day 60-74 ]
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.
Change History Complete list of historical versions of study NCT01519466 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2016)
  • HbA1c [ Time Frame: Day 1 compared with Day 74 ]
    HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74). The percentage of glycosylated hemoglobin in Diabetes Control and Complications Trial (DCCT) units was standardized to the newer International Federation of Clinical Chemistry (IFCC) units (mmol/mol).
  • Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60. [ Time Frame: Day 60 compared to day 1 ]
    The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (-3 to +3). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). There is one question to assess the change in satisfaction with perceived frequency of Hypoglycaemia and one question to assess change satisfaction with perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less satisfied) to +3 (much more satisfied). The 95% confidence intervals for the FreeStyle InsuLinx group DTSQc scores was calculated using a one-sample t-test.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2012)
  • Change in time spent in euglycaemia [ Time Frame: Day 1-15 compared with Day 60-74 ]
    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 ]
    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. ]
    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 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study
Official Title  ICMJE Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE
  • Device: FreeStyle InsuLinx
    FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
  • Device: FreeStyle Freedom Lite
    FreeStyle Freedom Lite is a blood glucose meter
Study Arms  ICMJE
  • Intervention
    Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
    Intervention: Device: FreeStyle InsuLinx
  • Control
    Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
    Intervention: Device: FreeStyle Freedom Lite
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2012)
55
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2012)
48
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01519466
Other Study ID Numbers  ICMJE ADC-PMR-INX-11012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Diabetes Care
Study Sponsor  ICMJE Abbott Diabetes Care
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Prof. Michaela Diamant VU University Medical Centre (VUMC)
PRS Account Abbott Diabetes Care
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP