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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

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
Enrollment 55
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title FreeStyle InsuLinx FreeStyle Freedom Lite
Hide Arm/Group Description

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.

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

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

Period Title: Overall Study
Started 33 16
Completed 33 16
Not Completed 0 0
Arm/Group Title FreeStyle InsuLinx FreeStyle Freedom Lite Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 33 16 49
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 16 participants 49 participants
44.4  (15.2) 43.4  (16.7) 44.1  (15.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 16 participants 49 participants
Female
16
  48.5%
7
  43.8%
23
  46.9%
Male
17
  51.5%
9
  56.3%
26
  53.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 16 participants 49 participants
Netherlands 8 4 12
Germany 25 12 37
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 33 participants 16 participants 49 participants
26.6  (3.6) 26.4  (4.4) 26.5  (3.8)
Duration of Diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 16 participants 49 participants
18.8  (14.1) 14.6  (8.0) 17.4  (12.5)
Screening HbA1c  
Mean (Standard Deviation)
Unit of measure:  Mmol/mol
Number Analyzed 33 participants 16 participants 49 participants
61.7  (7.7) 64.8  (6.8) 62.7  (7.5)
Screening HbA1c  
Mean (Standard Deviation)
Unit of measure:  Percentage of Glycosylated Haemoglobin
Number Analyzed 33 participants 16 participants 49 participants
7.8  (0.7) 8.1  (0.6) 7.9  (0.7)
1.Primary Outcome
Title Time in Target Blood Glucose Range
Hide Description 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)
Time Frame Day 1-15 compared with Day 60-74
Hide Outcome Measure Data
Hide Analysis Population Description
One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.
Arm/Group Title FreeStyle InsuLinx FreeStyle Freedom Lite
Hide Arm/Group Description:

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.

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

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

Overall Number of Participants Analyzed 32 16
Mean (Standard Deviation)
Unit of Measure: hours per day
Baseline 15.28  (2.76) 15.31  (3.15)
Final 14.56  (2.99) 14.14  (2.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FreeStyle InsuLinx
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0926
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.71
Confidence Interval (2-Sided) 95%
-1.55 to 0.12
Parameter Dispersion
Type: Standard Deviation
Value: 2.32
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FreeStyle Freedom Lite
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.17
Parameter Dispersion
Type: Standard Deviation
Value: 2.97
Estimation Comments [Not Specified]
2.Secondary Outcome
Title HbA1c
Hide Description

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).

Time Frame Day 1 compared with Day 74
Hide Outcome Measure Data
Hide Analysis Population Description
One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.
Arm/Group Title FreeStyle InsuLinx FreeStyle Freedom Lite
Hide Arm/Group Description:

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.

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

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

Overall Number of Participants Analyzed 32 16
Mean (Standard Deviation)
Unit of Measure: Percentage of Glycosylated Haemoglobin
Baseline 7.87  (0.76) 8.07  (0.76)
Final 7.78  (0.58) 7.98  (0.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FreeStyle InsuLinx
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3251
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.27 to 0.09
Parameter Dispersion
Type: Standard Deviation
Value: 0.49
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FreeStyle Freedom Lite
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.09
Parameter Dispersion
Type: Standard Deviation
Value: 0.51
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.
Hide Description

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.

Time Frame Day 60 compared to day 1
Hide Outcome Measure Data
Hide Analysis Population Description
One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.
Arm/Group Title FreeStyle InsuLinx FreeStyle Freedom Lite
Hide Arm/Group Description:

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.

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

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

Overall Number of Participants Analyzed 32 16
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Hyperglycaemia 0.13  (1.26) -0.25  (1.53)
Hypoglycaemia -0.31  (1.03) 0.13  (1.02)
Treatment Satisfaction 4.36  (6.53) 2.94  (7.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FreeStyle InsuLinx
Comments Hyperglycaemia, glucose above 10mmol/l (180mg/dL)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5798
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.33 to 0.58
Parameter Dispersion
Type: Standard Deviation
Value: 1.26
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FreeStyle InsuLinx
Comments Hypoglycaemia, glucose below 3.9mmol/l (70mg/dL)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0960
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.31
Confidence Interval (2-Sided) 95%
-0.68 to 0.06
Parameter Dispersion
Type: Standard Deviation
Value: 1.03
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection FreeStyle InsuLinx
Comments Treatment Satisfaction
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.36
Confidence Interval (2-Sided) 95%
2.01 to 6.71
Parameter Dispersion
Type: Standard Deviation
Value: 6.53
Estimation Comments [Not Specified]
Time Frame Adverse events collected from enrolment to completion by last subject (up to 3 months).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FreeStyle InsuLinx FreeStyle Freedom Lite
Hide Arm/Group Description

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.

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

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

All-Cause Mortality
FreeStyle InsuLinx FreeStyle Freedom Lite
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
FreeStyle InsuLinx FreeStyle Freedom Lite
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/33 (9.09%)      2/16 (12.50%)    
Ear and labyrinth disorders     
Middle ear effusion *  0/33 (0.00%)  0 1/16 (6.25%)  1
Infections and infestations     
Gingiva abcess *  0/33 (0.00%)  0 1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders     
Fractured Metacarpus *  1/33 (3.03%)  1 0/16 (0.00%)  0
Skin and subcutaneous tissue disorders     
Sensor tip *  1/33 (3.03%)  1 0/16 (0.00%)  0
Haematoma *  1/33 (3.03%)  1 0/16 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FreeStyle InsuLinx FreeStyle Freedom Lite
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/33 (24.24%)      4/16 (25.00%)    
Endocrine disorders     
Hypoglycaemia *  3/33 (9.09%)  3 1/16 (6.25%)  1
Infections and infestations     
Infection *  2/33 (6.06%)  2 1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders     
Cold *  4/33 (12.12%)  5 2/16 (12.50%)  3
Skin and subcutaneous tissue disorders     
Erythema *  0/33 (0.00%)  0 1/16 (6.25%)  1
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Snr Director, Clinical Development & Regulatory Affairs
Organization: Abbott Diabetes Care
Phone: 01993 863164
EMail: joe.bugler@abbott.com
Layout table for additonal information
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