Trial Outcomes & Findings for Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose Data (NCT NCT03028220)

NCT ID: NCT03028220

Last Updated: 2019-11-13

Results Overview

Percentage time spent in hypoglycaemia (\<3.3mmol/L, 60mg/dL) change from baseline

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 10 weeks
• Results posted on: 2019-11-13

Participant Flow

Participant milestones

Measure	Real Time Continuous Glucose Monitoring 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	Flash Glucose Monitoring 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 Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Real Time Continuous Glucose Monitoring n=20 Participants 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	Flash Glucose Monitoring n=20 Participants 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 n=40 Participants Total of all reporting groups
Sex: Female, Male Male	12 Participants n=20 Participants	12 Participants n=20 Participants	24 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	20 Participants n=20 Participants	20 Participants n=20 Participants	40 Participants n=40 Participants
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=20 Participants	20 Participants n=20 Participants	40 Participants n=40 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Continuous	50.5 years n=20 Participants	48.5 years n=20 Participants	49.5 years n=40 Participants
Sex: Female, Male Female	8 Participants n=20 Participants	8 Participants n=20 Participants	16 Participants n=40 Participants

PRIMARY outcome

Timeframe: 10 weeks

Percentage time spent in hypoglycaemia (<3.3mmol/L, 60mg/dL) change from baseline

Outcome measures

Measure	Real Time Continuous Glucose Monitoring n=19 Participants 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	Flash Glucose Monitoring n=20 Participants 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
% Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)	-3.0 percentage of time <3.3mmol/l Interval -5.0 to -0.3	1.3 percentage of time <3.3mmol/l Interval -1.4 to 3.6

SECONDARY outcome

Timeframe: 10 weeks

Percentage time spent in hypoglycaemia (<2.8mmol/L, 50mg/dL) change from baseline

Outcome measures

Measure	Real Time Continuous Glucose Monitoring n=19 Participants 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	Flash Glucose Monitoring n=20 Participants 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
% Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL)	-1.2 percentage of time <2.8mmol/l Interval -4.3 to -0.5	1.3 percentage of time <2.8mmol/l Interval -1.0 to 2.4

SECONDARY outcome

Timeframe: 10 weeks

Percentage time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL) change in baseline to endpint

Outcome measures

Measure	Real Time Continuous Glucose Monitoring n=19 Participants 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	Flash Glucose Monitoring n=20 Participants 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
% Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL)	-2.7 percentage of time <3.9mmol/l Interval -6.1 to -0.1	0.6 percentage of time <3.9mmol/l Interval -2.1 to 5.4

SECONDARY outcome

Timeframe: 10 weeks

Percentage time spent in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) change in baseline to endpoint

Outcome measures

Measure	Real Time Continuous Glucose Monitoring n=19 Participants 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	Flash Glucose Monitoring n=20 Participants 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
% Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)	10.6 percentage of time >3.9<7.8 mmol/l Interval 3.3 to 14.4	5.9 percentage of time >3.9<7.8 mmol/l Interval -2.4 to 9.0

SECONDARY outcome

Timeframe: 10 weeks

Percentage time spent in euglycaemia (3.9-10mmol/L, 70-180mg/dL) change in baseline to endpoint

Outcome measures

Measure	Real Time Continuous Glucose Monitoring n=19 Participants 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	Flash Glucose Monitoring n=20 Participants 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
% Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL)	12.7 percentage of time >3.9<10 mmol/l Interval 7.2 to 15.8	5.3 percentage of time >3.9<10 mmol/l Interval 1.1 to 11.7

SECONDARY outcome

Timeframe: 10 weeks

Percentage time spent in hyperglycaemia (>10mmol/L, 180mg/dL) change in baseline to endpoint

Outcome measures

Measure	Real Time Continuous Glucose Monitoring n=19 Participants 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	Flash Glucose Monitoring n=20 Participants 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
% Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL)	-8.6 percentage of time >10mmol/L Interval -13.0 to -1.1	-7.0 percentage of time >10mmol/L Interval -16.9 to 1.7

SECONDARY outcome

Timeframe: 10 weeks

% time spent in hyperglycaemia (>15mmol/L, 270mg/dL) change in baseline to endpoint

Outcome measures

Measure	Real Time Continuous Glucose Monitoring n=19 Participants 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	Flash Glucose Monitoring n=20 Participants 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
% Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL)	-4.9 percentage of time >15 mmol/l Interval -8.6 to -0.7	-3.1 percentage of time >15 mmol/l Interval -5.3 to -0.4

SECONDARY outcome

Timeframe: 8 weeks

Number of participants with hypoglycemic excursions

Outcome measures

Measure	Real Time Continuous Glucose Monitoring n=19 Participants 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	Flash Glucose Monitoring n=20 Participants 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
Hypoglycemia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 weeks

Number of participants with episodes of severe hypoglycaemia

Outcome measures

Measure	Real Time Continuous Glucose Monitoring n=19 Participants 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	Flash Glucose Monitoring n=20 Participants 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
Severe Hypoglycaemia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 weeks

Glucose Variability measured by Coefficient of variation (CV), on a decimal scale of 0-1

Outcome measures

Measure	Real Time Continuous Glucose Monitoring n=19 Participants 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	Flash Glucose Monitoring n=20 Participants 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
Changes in Glucose Variability Measured	-0.1 percent Interval -0.1 to 0.0	0.0 percent Interval -0.1 to 0.0

SECONDARY outcome

Timeframe: 8 weeks

Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE)

Outcome measures

Measure	Real Time Continuous Glucose Monitoring n=19 Participants 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	Flash Glucose Monitoring n=20 Participants 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
Glucose Variability Measured by MAGE	-1.5 mmol/L Interval -2.9 to -0.5	-0.4 mmol/L Interval -1.6 to 0.1

SECONDARY outcome

Timeframe: 8 weeks

Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA)

Outcome measures

Measure	Real Time Continuous Glucose Monitoring n=19 Participants 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	Flash Glucose Monitoring n=20 Participants 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
Glucose Variability Measured by CONGA	0.1 mmol/l Interval -0.5 to 0.2	0.1 mmol/l Interval -0.1 to 0.2

Adverse Events

Real Time Continuous Glucose Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Flash Glucose Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof Nick Oliver

Imperial College London

Phone: 02075942460

Email: nick.oliver@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place