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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: March 3, 2016
Last verified: March 2016
History of Changes
Results First Received: November 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Type 1 Diabetes
Interventions: Device: FreeStyle InsuLinx
Device: FreeStyle Freedom Lite

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 55 subjects consented and enrolled into the study. Six of these withdrew before randomisation or failed screening. Forty-nine (49) subjects were randomised and completed the study.

Reporting Groups
  Description
FreeStyle InsuLinx

Subjects will use a FreeStyle InsuLinx blood glucose meter during the study

FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
FreeStyle Freedom Lite

Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.

FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter

Participant Flow:   Overall Study
    FreeStyle InsuLinx     FreeStyle Freedom Lite  
STARTED     33     16  
COMPLETED     33     16  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A total of 55 subjects consented and enrolled into the study. Six of these withdrew before randomisation or failed screening. Forty-nine (49) subjects were randomised and completed the study.

Reporting Groups
  Description
FreeStyle InsuLinx

Subjects will use a FreeStyle InsuLinx blood glucose meter during the study

FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
FreeStyle Freedom Lite

Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.

FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter
Total Total of all reporting groups

Baseline Measures
    FreeStyle InsuLinx     FreeStyle Freedom Lite     Total  
Number of Participants  
[units: participants]
 		  33     16     49  
Age  
[units: years]
Mean (Standard Deviation) 		  44.4  (15.2)     43.4  (16.7)     44.1  (15.6)  
Gender  
[units: participants]
 		     
Female     16     7     23  
Male     17     9     26  
Region of Enrollment  
[units: participants]
 		     
Netherlands     8     4     12  
Germany     25     12     37  
Body Mass Index (BMI)  
[units: kg/m²]
Mean (Standard Deviation) 		  26.6  (3.6)     26.4  (4.4)     26.5  (3.8)  
Duration of Diabetes  
[units: years]
Mean (Standard Deviation) 		  18.8  (14.1)     14.6  (8.0)     17.4  (12.5)  
Screening HbA1c  
[units: mmol/mol]
Mean (Standard Deviation) 		  61.7  (7.7)     64.8  (6.8)     62.7  (7.5)  
Screening HbA1c  
[units: Percentage of Glycosylated Haemoglobin]
Mean (Standard Deviation) 		  7.8  (0.7)     8.1  (0.6)     7.9  (0.7)  



  Outcome Measures
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1.  Primary:   Time in Target Blood Glucose Range   [ Time Frame: Day 1-15 compared with Day 60-74 ]
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2.  Secondary:   HbA1c   [ Time Frame: Day 1 compared with Day 74 ]
  Show Outcome Measure 2

3.  Secondary:   Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.   [ Time Frame: Day 60 compared to day 1 ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Snr Director, Clinical Development & Regulatory Affairs
Organization: Abbott Diabetes Care
phone: 01993 863164
e-mail: joe.bugler@abbott.com



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
Results First Received: November 12, 2015
Last Updated: March 3, 2016
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Ethics Commission