Trial Outcomes & Findings for How Common is Hypoglycaemia in Older People With Diabetes Who Fall? (NCT NCT05470842)

Results Overview

Number of patients who experienced more than 15 minutes of hypoglycaemia within the 10-day sensor lifespan and data capture period.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

10 days

Results posted on

2024-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	Continuous Glucose Monitoring Continuous Glucose Monitoring Device for up to 10 days Continuous glucose monitoring (Dexcom G6): All participants will be issued with the Dexcom G6 device. The trial team will buy the readers or smartphones and sensors and provide the participants with all the necessary equipment. Participants will be shown how to wear the Dexcom G6 device, which they will be asked to wear for up to 10 days (=the lifespan of one sensor). There will be no change in the standard care of the participants' diabetes management, during the study period.
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

How Common is Hypoglycaemia in Older People With Diabetes Who Fall?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous Glucose Monitoring n=12 Participants Continuous Glucose Monitoring Device for up to 10 days Continuous glucose monitoring (Dexcom G6): All participants will be issued with the Dexcom G6 device. The trial team will buy the readers or smartphones and sensors and provide the participants with all the necessary equipment. Participants will be shown how to wear the Dexcom G6 device, which they will be asked to wear for up to 10 days (=the lifespan of one sensor). There will be no change in the standard care of the participants' diabetes management, during the study period.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants
Region of Enrollment United Kingdom	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 days

Number of patients who experienced more than 15 minutes of hypoglycaemia within the 10-day sensor lifespan and data capture period.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitoring n=11 Participants Continuous Glucose Monitoring Device for up to 10 days Continuous glucose monitoring (Dexcom G6): All participants will be issued with the Dexcom G6 device. The trial team will buy the readers or smartphones and sensors and provide the participants with all the necessary equipment. Participants will be shown how to wear the Dexcom G6 device, which they will be asked to wear for up to 10 days (=the lifespan of one sensor). There will be no change in the standard care of the participants' diabetes management, during the study period.
Proportion of Participants With Captured Hypoglycaemia	3 Participants

SECONDARY outcome

Timeframe: 10 days

Population: Completers of the monitoring period

The percentage of time glucose concentrations in the 10-day monitoring period that were within the defined target range (3.9 - 10.0 mmol) as specified by international consensus.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitoring n=11 Participants Continuous Glucose Monitoring Device for up to 10 days Continuous glucose monitoring (Dexcom G6): All participants will be issued with the Dexcom G6 device. The trial team will buy the readers or smartphones and sensors and provide the participants with all the necessary equipment. Participants will be shown how to wear the Dexcom G6 device, which they will be asked to wear for up to 10 days (=the lifespan of one sensor). There will be no change in the standard care of the participants' diabetes management, during the study period.
Overall Time in Range (Average)	52 percentage of Time in Range Standard Deviation 23

SECONDARY outcome

Timeframe: 30 days

Population: Completers analysed

Number of participants with hospital admissions and emergency department attendances within 30 days of sensor monitoring. Review of hospital records to ascertain date of admission and clinical presentation.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitoring n=11 Participants Continuous Glucose Monitoring Device for up to 10 days Continuous glucose monitoring (Dexcom G6): All participants will be issued with the Dexcom G6 device. The trial team will buy the readers or smartphones and sensors and provide the participants with all the necessary equipment. Participants will be shown how to wear the Dexcom G6 device, which they will be asked to wear for up to 10 days (=the lifespan of one sensor). There will be no change in the standard care of the participants' diabetes management, during the study period.
Emergency Department Re-attendances and/or Hospital Re-admissions for Falls, Fractures, Heart Attacks, Ischaemic Strokes and Death Within 30 Days	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 days

Population: Subgroup of participants who were found to have hypoglycaemic events

Number of minutes the blood glucose was within the hypoglycaemic range in the participants who experienced hypoglycaemic events.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitoring n=3 Participants Continuous Glucose Monitoring Device for up to 10 days Continuous glucose monitoring (Dexcom G6): All participants will be issued with the Dexcom G6 device. The trial team will buy the readers or smartphones and sensors and provide the participants with all the necessary equipment. Participants will be shown how to wear the Dexcom G6 device, which they will be asked to wear for up to 10 days (=the lifespan of one sensor). There will be no change in the standard care of the participants' diabetes management, during the study period.
For Participants Who Experienced Hypoglycaemic Events, the Amount of Time (Minutes) They Were in the Hypoglycaemic Range	40 minutes Interval 30.0 to 330.0

Adverse Events

Continuous Glucose Monitoring

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Continuous Glucose Monitoring n=11 participants at risk Continuous Glucose Monitoring Device for up to 10 days Continuous glucose monitoring (Dexcom G6): All participants will be issued with the Dexcom G6 device. The trial team will buy the readers or smartphones and sensors and provide the participants with all the necessary equipment. Participants will be shown how to wear the Dexcom G6 device, which they will be asked to wear for up to 10 days (=the lifespan of one sensor). There will be no change in the standard care of the participants' diabetes management, during the study period.
Cardiac disorders Congestive cardiac failure	9.1% 1/11 • 30 days from completion of collection of continuous glucose monitoring data

Other adverse events

Adverse event data not reported

Additional Information

Dr Katharina Mattishent

UNiversity of East Anglia

Phone: 01603286286

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place