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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (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
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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
Overall Participants Analyzed; [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 ]

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3. Secondary:

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

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  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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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: 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. 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. 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
First Submitted:	January 6, 2012
First Posted:	January 27, 2012
Results First Submitted:	November 12, 2015
Results First Posted:	April 1, 2016
Last Update Posted:	April 1, 2016