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Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose Data (I HART-CGM)

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ClinicalTrials.gov Identifier: NCT03028220
Recruitment Status : Completed
First Posted : January 23, 2017
Results First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Type 1 Diabetes Mellitus With Hypoglycemia
Impaired Awareness of Hypoglycemia
Type1diabetes
Interventions Device: Dexcom G5 Continuous Glucose Monitor
Device: Abbott Freestyle Libre
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Real Time Continuous Glucose Monitoring Flash Glucose Monitoring
Hide Arm/Group Description

Use of Dexcom G5 continuous glucose monitoring

Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values

Use of Abbott FreeStyle Libre flash glucose monitoring

Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data

Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Real Time Continuous Glucose Monitoring Flash Glucose Monitoring Total
Hide Arm/Group Description

Use of Dexcom G5 continuous glucose monitoring

Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values

Use of Abbott FreeStyle Libre flash glucose monitoring

Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data

Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
1 participant in the CGM group was randomised and completed the trial but the CGM data could not be analysed due to an uploading error. All other data was analysed for this participant.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
50.5
(45 to 64.5)
48.5
(34 to 63)
49.5
(37.5 to 63.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
8
  40.0%
8
  40.0%
16
  40.0%
Male
12
  60.0%
12
  60.0%
24
  60.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United Kingdom Number Analyzed 20 participants 20 participants 40 participants
20
 100.0%
20
 100.0%
40
 100.0%
1.Primary Outcome
Title % Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)
Hide Description Percentage time spent in hypoglycaemia (<3.3mmol/L, 60mg/dL) change from baseline
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real Time Continuous Glucose Monitoring Flash Glucose Monitoring
Hide Arm/Group Description:

Use of Dexcom G5 continuous glucose monitoring

Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values

Use of Abbott FreeStyle Libre flash glucose monitoring

Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data

Overall Number of Participants Analyzed 19 20
Median (Inter-Quartile Range)
Unit of Measure: percentage of time <3.3mmol/l
-3.0
(-5.0 to -0.3)
1.3
(-1.4 to 3.6)
2.Secondary Outcome
Title % Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL)
Hide Description Percentage time spent in hypoglycaemia (<2.8mmol/L, 50mg/dL) change from baseline
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real Time Continuous Glucose Monitoring Flash Glucose Monitoring
Hide Arm/Group Description:

Use of Dexcom G5 continuous glucose monitoring

Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values

Use of Abbott FreeStyle Libre flash glucose monitoring

Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data

Overall Number of Participants Analyzed 19 20
Median (95% Confidence Interval)
Unit of Measure: percentage of time <2.8mmol/l
-1.2
(-4.3 to -0.5)
1.3
(-1.0 to 2.4)
3.Secondary Outcome
Title % Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL)
Hide Description Percentage time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL) change in baseline to endpint
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real Time Continuous Glucose Monitoring Flash Glucose Monitoring
Hide Arm/Group Description:

Use of Dexcom G5 continuous glucose monitoring

Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values

Use of Abbott FreeStyle Libre flash glucose monitoring

Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data

Overall Number of Participants Analyzed 19 20
Median (95% Confidence Interval)
Unit of Measure: percentage of time <3.9mmol/l
-2.7
(-6.1 to -0.1)
0.6
(-2.1 to 5.4)
4.Secondary Outcome
Title % Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)
Hide Description Percentage time spent in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) change in baseline to endpoint
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real Time Continuous Glucose Monitoring Flash Glucose Monitoring
Hide Arm/Group Description:

Use of Dexcom G5 continuous glucose monitoring

Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values

Use of Abbott FreeStyle Libre flash glucose monitoring

Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data

Overall Number of Participants Analyzed 19 20
Median (95% Confidence Interval)
Unit of Measure: percentage of time >3.9<7.8 mmol/l
10.6
(3.3 to 14.4)
5.9
(-2.4 to 9.0)
5.Secondary Outcome
Title % Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL)
Hide Description Percentage time spent in euglycaemia (3.9-10mmol/L, 70-180mg/dL) change in baseline to endpoint
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real Time Continuous Glucose Monitoring Flash Glucose Monitoring
Hide Arm/Group Description:

Use of Dexcom G5 continuous glucose monitoring

Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values

Use of Abbott FreeStyle Libre flash glucose monitoring

Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data

Overall Number of Participants Analyzed 19 20
Median (95% Confidence Interval)
Unit of Measure: percentage of time >3.9<10 mmol/l
12.7
(7.2 to 15.8)
5.3
(1.1 to 11.7)
6.Secondary Outcome
Title % Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL)
Hide Description Percentage time spent in hyperglycaemia (>10mmol/L, 180mg/dL) change in baseline to endpoint
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real Time Continuous Glucose Monitoring Flash Glucose Monitoring
Hide Arm/Group Description:

Use of Dexcom G5 continuous glucose monitoring

Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values

Use of Abbott FreeStyle Libre flash glucose monitoring

Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data

Overall Number of Participants Analyzed 19 20
Median (95% Confidence Interval)
Unit of Measure: percentage of time >10mmol/L
-8.6
(-13.0 to -1.1)
-7.0
(-16.9 to 1.7)
7.Secondary Outcome
Title % Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL)
Hide Description % time spent in hyperglycaemia (>15mmol/L, 270mg/dL) change in baseline to endpoint
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real Time Continuous Glucose Monitoring Flash Glucose Monitoring
Hide Arm/Group Description:

Use of Dexcom G5 continuous glucose monitoring

Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values

Use of Abbott FreeStyle Libre flash glucose monitoring

Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data

Overall Number of Participants Analyzed 19 20
Median (95% Confidence Interval)
Unit of Measure: percentage of time >15 mmol/l
-4.9
(-8.6 to -0.7)
-3.1
(-5.3 to -0.4)
8.Secondary Outcome
Title Hypoglycemia
Hide Description Number of participants with hypoglycemic excursions
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real Time Continuous Glucose Monitoring Flash Glucose Monitoring
Hide Arm/Group Description:

Use of Dexcom G5 continuous glucose monitoring

Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values

Use of Abbott FreeStyle Libre flash glucose monitoring

Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data

Overall Number of Participants Analyzed 19 20
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Severe Hypoglycaemia
Hide Description Number of participants with episodes of severe hypoglycaemia
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real Time Continuous Glucose Monitoring Flash Glucose Monitoring
Hide Arm/Group Description:

Use of Dexcom G5 continuous glucose monitoring

Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values

Use of Abbott FreeStyle Libre flash glucose monitoring

Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data

Overall Number of Participants Analyzed 19 20
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Glucose Variability Measured by CV
Hide Description Glucose Variability measured by Coefficient of variation (CV)
Time Frame 8 weeks
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Glucose Variability Measured by MAGE
Hide Description Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE)
Time Frame 8 weeks
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Glucose Variability Measured by CONGA
Hide Description Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA)
Time Frame 8 weeks
Outcome Measure Data Not Reported
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Real Time Continuous Glucose Monitoring Flash Glucose Monitoring
Hide Arm/Group Description

Use of Dexcom G5 continuous glucose monitoring

Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values

Use of Abbott FreeStyle Libre flash glucose monitoring

Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data

All-Cause Mortality
Real Time Continuous Glucose Monitoring Flash Glucose Monitoring
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Real Time Continuous Glucose Monitoring Flash Glucose Monitoring
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Real Time Continuous Glucose Monitoring Flash Glucose Monitoring
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof Nick Oliver
Organization: Imperial College London
Phone: 02075942460
EMail: nick.oliver@imperial.ac.uk
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03028220     History of Changes
Other Study ID Numbers: 15HH2875
First Submitted: December 16, 2016
First Posted: January 23, 2017
Results First Submitted: August 10, 2018
Results First Posted: April 15, 2019
Last Update Posted: April 15, 2019