Trial Outcomes & Findings for Assessment of the Impact of Real-Time Continuous Glucose Monitoring on People Presenting With Severe Hypoglycaemia (NCT NCT03748433)

NCT ID: NCT03748433

Last Updated: 2024-03-22

Results Overview

Percentage time spent in hypoglycaemia (\<3.0mmol/L, 55mg/dL)

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 35 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2024-03-22

Participant Flow

Recruitment was undertaken in collaboration with the London Ambulance Service. Participants were identified following an episode of severe hypoglycaemia. Following any questions, London Ambulance Services and Emergency Departments obtained verbal consent to share details with study investigators, and sent details to principal investigator through a secure website (NHS.net account). Prrticipants had to be enrolled within two weeks of the severehypoglycaemia episode.

Once participants were enrolled they were randomised to either real-time CGM (intervention) or self-monitoring of blood glucose (standard care) for 12 weeks.

Participant milestones

Measure	Continuous Glucose Monitoring (CGM) The RT CGM group will receive a Dexcom G6 transmitter and sensors, as well as a structured education refresher focusing on hypoglycaemia avoidance, recognition, and management. Dexcom G6 CGM: Commercially available Dexcom G6 Continuous Glucose Monitoring	Self Monitoring Blood Glucose (SMBG) The SMBG group will additionally undergo blinded CGM at weeks 1 and 2, weeks 4 to 6 and weeks 9 to 12 using the Dexcom G6 system. Participants in this group will be shown how to insert the Dexcom G6 at the first clinic visit and sensors provided so they can do this at home.
Overall Study STARTED	17	18
Overall Study COMPLETED	16	14
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of the Impact of Real-Time Continuous Glucose Monitoring on People Presenting With Severe Hypoglycaemia

Baseline characteristics by cohort

Measure	Continuous Glucose Monitoring (CGM) n=16 Participants The RT CGM group will receive a Dexcom G6 transmitter and sensors, as well as a structured education refresher focusing on hypoglycaemia avoidance, recognition, and management. Dexcom G6 CGM: Commercially available Dexcom G6 Continuous Glucose Monitoring	Self Monitoring Blood Glucose (SMBG) n=14 Participants The SMBG group will additionally undergo blinded CGM at weeks 1 and 2, weeks 4 to 6 and weeks 9 to 12 using the Dexcom G6 system. Participants in this group will be shown how to insert the Dexcom G6 at the first clinic visit and sensors provided so they can do this at home.	Total n=30 Participants Total of all reporting groups
Age, Continuous	38.5 years n=5 Participants	45.5 years n=7 Participants	41 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United Kingdom	16 participants n=5 Participants	14 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Participants who had sufficient data were included in analysis of primary outcome

Percentage time spent in hypoglycaemia (<3.0mmol/L, 55mg/dL)

Outcome measures

Measure	Continuous Glucose Monitoring (CGM) n=15 Participants The RT CGM group will receive a Dexcom G6 transmitter and sensors, as well as a structured education refresher focusing on hypoglycaemia avoidance, recognition, and management. Dexcom G6 CGM: Commercially available Dexcom G6 Continuous Glucose Monitoring	Self Monitoring Blood Glucose (SMBG) n=8 Participants The SMBG group will additionally undergo blinded CGM at weeks 1 and 2, weeks 4 to 6 and weeks 9 to 12 using the Dexcom G6 system. Participants in this group will be shown how to insert the Dexcom G6 at the first clinic visit and sensors provided so they can do this at home.
Time Spent in Hypoglycaemia	1.8 percentage time Interval 0.3 to 3.4	3.3 percentage time Interval 1.9 to 5.7

Adverse Events

Continuous Glucose Monitoring (CGM)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Self Monitoring Blood Glucose (SMBG)

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Continuous Glucose Monitoring (CGM) n=16 participants at risk The RT CGM group will receive a Dexcom G6 transmitter and sensors, as well as a structured education refresher focusing on hypoglycaemia avoidance, recognition, and management. Dexcom G6 CGM: Commercially available Dexcom G6 Continuous Glucose Monitoring	Self Monitoring Blood Glucose (SMBG) n=14 participants at risk The SMBG group will additionally undergo blinded CGM at weeks 1 and 2, weeks 4 to 6 and weeks 9 to 12 using the Dexcom G6 system. Participants in this group will be shown how to insert the Dexcom G6 at the first clinic visit and sensors provided so they can do this at home.
Endocrine disorders Unrelated to intervention	0.00% 0/16 • 1 year Each participant was in the study intervention/control for 3 months	28.6% 4/14 • Number of events 4 • 1 year Each participant was in the study intervention/control for 3 months

Other adverse events

Adverse event data not reported

Additional Information

Professor Nick Oliver

Imperial College London

Phone: +44 (0)20 7594 1796

Email: nick.oliver@imperial.ac.uk

Results disclosure agreements

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