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An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT) (IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02232698
Recruitment Status : Completed
First Posted : September 5, 2014
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
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: Other
Condition Type 1 Diabetes Mellitus
Interventions Device: Sensor Based Glucose Monitoring System
Device: Standard Blood Glucose Monitoring
Enrollment 328
Recruitment Details  
Pre-assignment Details A total of 328 subjects consented and enrolled into the study. Eighty-seven (87) of these failed screening or withdrew before randomisation. Two hundred and forty-one (241) subjects were randomised and 211 completed the study.
Arm/Group Title Sensor Based Glucose Monitoring System Standard Blood Glucose Monitoring
Hide Arm/Group Description

Standard sensing system use for 6 months.

Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.

Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Period Title: Overall Study
Started 120 121
Completed 110 101
Not Completed 10 20
Reason Not Completed
Pregnancy             1             1
Met exclusion criteria             1             1
Had device-associated symptoms             7             0
Non-compliance with study device             1             4
Allocated to control group             0             3
Withdrawal by Subject             0             11
Arm/Group Title Sensor Based Glucose Monitoring System Standard Blood Glucose Monitoring Total
Hide Arm/Group Description

Standard sensing system use for 6 months.

Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.

Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Total of all reporting groups
Overall Number of Baseline Participants 119 120 239
Hide Baseline Analysis Population Description
2 pregnant subjects (1 in each group) were excluded from all efficacy analysis (as stated in the protocol).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 119 participants 120 participants 239 participants
42.4  (13.1) 45.0  (14.6) 43.7  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 120 participants 239 participants
Female
42
  35.3%
61
  50.8%
103
  43.1%
Male
77
  64.7%
59
  49.2%
136
  56.9%
Screening HbA1c  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 119 participants 120 participants 239 participants
6.73  (0.52) 6.74  (0.59) 6.74  (0.56)
Screening HbA1c  
Mean (Standard Deviation)
Unit of measure:  Mmol/mol
Number Analyzed 119 participants 120 participants 239 participants
50.1  (5.7) 50.2  (6.5) 50.1  (6.1)
1.Primary Outcome
Title Time Spent <70 mg/dL
Hide Description Difference in time <70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Time Frame Baseline and Days 194 to 208
Hide Outcome Measure Data
Hide Analysis Population Description
1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.
Arm/Group Title Sensor Based Glucose Monitoring System Standard Blood Glucose Monitoring
Hide Arm/Group Description:

Standard sensing system use for 6 months.

Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.

Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Overall Number of Participants Analyzed 119 119
Mean (Standard Deviation)
Unit of Measure: hours per day
Baseline 3.38  (2.31) 3.44  (2.62)
Days 194-208 2.03  (1.93) 3.27  (2.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sensor Based Glucose Monitoring System, Standard Blood Glucose Monitoring
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.239
Estimation Comments [Not Specified]
2.Secondary Outcome
Title HbA1c at 6 Months
Hide Description Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1
Time Frame Baseline and Day 208
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sensor Based Glucose Monitoring System Standard Blood Glucose Monitoring
Hide Arm/Group Description:

Standard sensing system use for 6 months.

Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.

Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Overall Number of Participants Analyzed 119 120
Mean (Standard Deviation)
Unit of Measure: percentage of Glycated Haemoglobin
Baseline 6.79  (0.52) 6.78  (0.64)
Day 208 6.94  (0.65) 6.95  (0.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sensor Based Glucose Monitoring System, Standard Blood Glucose Monitoring
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9556
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.059
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time Spent <55 mg/dL and <40 mg/dL
Hide Description Difference in time <55 mg/dL & <40 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Time Frame Baseline and Days 194 to 208
Hide Outcome Measure Data
Hide Analysis Population Description
1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.
Arm/Group Title Sensor Based Glucose Monitoring System Standard Blood Glucose Monitoring
Hide Arm/Group Description:

Standard sensing system use for 6 months.

Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.

Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Overall Number of Participants Analyzed 119 119
Mean (Standard Deviation)
Unit of Measure: hours per day
Time spent <55 mg/dL, Baseline 1.59  (1.42) 1.77  (1.86)
Time spent <55 mg/dL, Days 194-208 0.80  (0.96) 1.65  (1.97)
Time spent <40 mg/dL, Baseline 0.59  (0.85) 0.75  (1.11)
Time spent <40 mg/dL, Days 194-208 0.26  (0.47) 0.73  (1.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sensor Based Glucose Monitoring System, Standard Blood Glucose Monitoring
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical analysis of time spent <55 mg/dL
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.82
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.175
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sensor Based Glucose Monitoring System, Standard Blood Glucose Monitoring
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments Statistical analysis of time spent <40 mg/dL
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.122
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL
Hide Description Difference in frequency of episodes <70 mg/dL, <55 mg/dL and <40 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Time Frame Baseline and Days 194-208
Hide Outcome Measure Data
Hide Analysis Population Description
1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.
Arm/Group Title Sensor Based Glucose Monitoring System Standard Blood Glucose Monitoring
Hide Arm/Group Description:

Standard sensing system use for 6 months.

Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.

Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Overall Number of Participants Analyzed 119 119
Mean (Standard Deviation)
Unit of Measure: number of episodes per day
Frequency of episodes <70 mg/dL, Baseline 1.81  (0.90) 1.67  (0.80)
Frequency of episodes <70 mg/dL, Days 194-208 1.32  (0.81) 1.69  (0.83)
Frequency of episodes <55 mg/dL, Baseline 0.96  (0.65) 0.92  (0.73)
Frequency of episodes <55 mg/dL, Days 194-208 0.56  (0.55) 0.92  (0.74)
Frequency of episodes <40 mg/dL, Baseline 0.39  (0.43) 0.44  (0.51)
Frequency of episodes <40 mg/dL, Days 194-208 0.19  (0.29) 0.43  (0.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sensor Based Glucose Monitoring System, Standard Blood Glucose Monitoring
Comments Statistical analysis of frequency of episodes <70 mg/dL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.089
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sensor Based Glucose Monitoring System, Standard Blood Glucose Monitoring
Comments Statistical analysis of frequency of episodes <55 mg/dL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.074
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sensor Based Glucose Monitoring System, Standard Blood Glucose Monitoring
Comments Statistical analysis of frequency of episodes <40 mg/dL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.050
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time Spent >180 mg/dL and >240 mg/dL
Hide Description Difference in time >180 mg/dL and >240 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Time Frame Baseline and Days 194 to 208
Hide Outcome Measure Data
Hide Analysis Population Description
1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.
Arm/Group Title Sensor Based Glucose Monitoring System Standard Blood Glucose Monitoring
Hide Arm/Group Description:

Standard sensing system use for 6 months.

Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.

Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Overall Number of Participants Analyzed 119 119
Mean (Standard Deviation)
Unit of Measure: hours per day
Time spent >180 mg/dL, Baseline 5.62  (2.48) 5.80  (3.11)
Time spent >180 mg/dL, Days 194-208 6.16  (3.05) 6.08  (3.20)
Time spent >240 mg/dL, Baseline 1.85  (1.44) 1.91  (1.70)
Time spent >240 mg/dL, Days 194-208 1.67  (1.36) 2.06  (1.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sensor Based Glucose Monitoring System, Standard Blood Glucose Monitoring
Comments Statistical analysis of time spent >180 mg/dL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5623
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.329
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sensor Based Glucose Monitoring System, Standard Blood Glucose Monitoring
Comments Statistical analysis for time spent >240 mg/dL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0247
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.163
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time in Range
Hide Description Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range).
Time Frame Baseline and Days 194 to 208
Hide Outcome Measure Data
Hide Analysis Population Description
1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.
Arm/Group Title Sensor Based Glucose Monitoring System Standard Blood Glucose Monitoring
Hide Arm/Group Description:

Standard sensing system use for 6 months.

Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.

Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Overall Number of Participants Analyzed 119 119
Mean (Standard Deviation)
Unit of Measure: hours per day
Baseline 15.0  (2.5) 14.8  (2.8)
Days 194-208 15.8  (2.9) 14.6  (2.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sensor Based Glucose Monitoring System, Standard Blood Glucose Monitoring
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.30
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Glucose Measurements Performed
Hide Description Number of blood glucose fingerstick tests per day by intervention and control group during baseline (days 1 to 15) and days 194 to 208. The number of sensor scans performed performed by the intervention group during days 15 to 208.
Time Frame Days 1 to 208
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sensor Based Glucose Monitoring System Standard Blood Glucose Monitoring
Hide Arm/Group Description:

Standard sensing system use for 6 months.

Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.

Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Overall Number of Participants Analyzed 106 93
Mean (Standard Deviation)
Unit of Measure: number of measurements per day
Number of fingerstick tests, Baseline 5.5  (2.0) 5.8  (1.7)
Number of fingerstick tests, Days 194-208 0.6  (1.0) 5.6  (2.2)
Number of sensor scans, Days 15-208 15.1  (6.9) NA [1]   (NA)
[1]
Number of sensor scans does not apply to this group as they did not use the sensor to self-manage their glucose levels.
8.Secondary Outcome
Title System Utilisation
Hide Description System utilisation assessed by percentage of sensor glucose data collected by the intervention group
Time Frame Days 15 to 208
Hide Outcome Measure Data
Hide Analysis Population Description
112 subjects included in the analysis, 7 were not included due to missing data.
Arm/Group Title Sensor Based Glucose Monitoring System
Hide Arm/Group Description:

Standard sensing system use for 6 months.

Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: percentage of sensor glucose collected
92.8  (7.3)
9.Secondary Outcome
Title Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208
Time Frame Baseline and Day 208
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sensor Based Glucose Monitoring System Standard Blood Glucose Monitoring
Hide Arm/Group Description:

Standard sensing system use for 6 months.

Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.

Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Overall Number of Participants Analyzed 103 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
Hyperglycaemia -0.6  (1.6) 0.5  (1.2)
Hypoglycaemia -0.3  (1.6) 0.1  (1.1)
Treatment Satisfaction 13.4  (5.5) 7.2  (6.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sensor Based Glucose Monitoring System, Standard Blood Glucose Monitoring
Comments Statistical analysis of perceived frequency of hyperglycaemia
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sensor Based Glucose Monitoring System, Standard Blood Glucose Monitoring
Comments Statistical analysis of perceived frequency of hypoglycaemia
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0713
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sensor Based Glucose Monitoring System, Standard Blood Glucose Monitoring
Comments Statistical analysis of total treatment satisfaction score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.84
Estimation Comments [Not Specified]
Time Frame Adverse events collected from enrolment (6 months)
Adverse Event Reporting Description

In addition to the serious adverse events listed below, 1 subject reported a serious adverse event of hypoglycaemia during the baseline phase (prior to randomisation), this subject was subsequently randomised to the Sensor Based Glucose Monitoring group.

No serious adverse events were related to the study device.

 
Arm/Group Title Sensor Based Glucose Monitoring System Standard Blood Glucose Monitoring
Hide Arm/Group Description

Standard sensing system use for 6 months.

Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.

Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

All-Cause Mortality
Sensor Based Glucose Monitoring System Standard Blood Glucose Monitoring
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sensor Based Glucose Monitoring System Standard Blood Glucose Monitoring
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/120 (3.33%)      4/121 (3.31%)    
Cardiac disorders     
atrial fibrillation * 1  1/120 (0.83%)  1 0/121 (0.00%)  0
Gastrointestinal disorders     
retroperitoneal haematoma * 1  1/120 (0.83%)  1 0/121 (0.00%)  0
Metabolism and nutrition disorders     
hyperglycaemia * 1  0/120 (0.00%)  0 1/121 (0.83%)  1
hypoglycaemia * 1  2/120 (1.67%)  2 3/121 (2.48%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sensor Based Glucose Monitoring System Standard Blood Glucose Monitoring
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/120 (27.50%)      24/121 (19.83%)    
General disorders     
medical device site reaction * 1  10/120 (8.33%)  13 0/121 (0.00%)  0
Infections and infestations     
influenza * 1  7/120 (5.83%)  7 7/121 (5.79%)  7
nasopharyngitis * 1  19/120 (15.83%)  20 17/121 (14.05%)  19
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.1)
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
Name/Title: Snr Director, Clinical Development & Regulatory Affairs
Organization: Abbott Diabetes Care
Phone: 01993 863164
Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT02232698     History of Changes
Other Study ID Numbers: ADC-CI-APO-13019
First Submitted: September 3, 2014
First Posted: September 5, 2014
Results First Submitted: January 6, 2017
Results First Posted: April 10, 2017
Last Update Posted: April 10, 2017