NCT05470842

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

How Common is Hypoglycaemia in Older People With Diabetes Who Have Falls, Dizziness or Other Symptoms Suggestive of Hypoglycaemia? A Continuous Glucose Monitoring Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of East Anglia · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to use 24 hour continuous glucose monitoring in older patients with diabetes who present with symptoms of falls, or dizziness, or confusion, that may indicate hypoglycaemia.

Detailed description

Background and study aims Patients with diabetes can be treated with medications (such as insulin or sulfonylureas) that can lower the sugar levels too much (hypos). A hypo means that the brain does not get enough energy. A person can become confused, dizzy, pass out, and/or have a fall. Older people with diabetes often seek treatment in hospital for symptoms such as falls, dizziness or feeling muddled. Health care professionals will order tests to investigate the possible causes for the fall, being muddled or dizzy, which can include a review of medications, checking blood pressures and the heart. However, it has previously been difficult to obtain 24-hour blood sugar monitoring in older people with diabetes to check if hypos could be an important contributing factor to their falls and dizzy spells. Continuous Glucose Monitoring (CGM) allows non-stop monitoring with a sensor that sits just under the skin. This sends sugar readings to a smartphone every few minutes (via Bluetooth) for 10 days. This enables full evaluation of the amount of time a person's sugar is in the target range, and the time in the low/high ranges. Medical research with CGM has revealed that some older people are suffering from substantial periods of hypos that they are not aware of. During this study, older people with diabetes will be asked to wear a CGM device for 10 days to investigate possibility of hypos.

Conditions

• Diabetes
• Hypoglycaemia

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-06-06
• Primary completion: 2023-09-22
• Completion: 2023-10-31
• First posted: 2022-07-22
• Last updated: 2024-09-23
• Results posted: 2024-09-23

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study