Clinical trial NCT05470842: How Common is Hypoglycaemia in Older People With Diabetes Who Fall?
Official title: How Common is Hypoglycaemia in Older People With Diabetes Who Have Falls, Dizziness or Other Symptoms Suggestive of Hypoglycaemia? A Continuous Glucose Monitoring Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypoglycaemia
Lead sponsor: University of East Anglia
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 12
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-centre, single arm study
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 75 years and older with diabetes
* Treated with glucose-medications which carry a high risk of hypoglycaemia (sulfonylureas and/or insulin)
* Presenting to hospital with a fall and/or symptoms suggestive of unrecognised hypoglycaemia (such as dizziness, feeling muddled).

Exclusion Criteria:

* Treatment with metformin alone
* Lack of capacity,
* Not willing to participate,
* Terminal illness (less than one-year life expectancy).
* Evidence of bruising, bleeding, cellulitis and/or skin tears on the upper arms or abdomen.

Primary outcomes:
measure: Proportion of Participants With Captured Hypoglycaemia
timeFrame: 10 days
Secondary outcomes:
measure: Overall Time in Range (Average)
timeFrame: 10 days
measure: Emergency Department Re-attendances and/or Hospital Re-admissions for Falls, Fractures, Heart Attacks, Ischaemic Strokes and Death Within 30 Days
timeFrame: 30 days
Other outcomes:
measure: For Participants Who Experienced Hypoglycaemic Events, the Amount of Time (Minutes) They Were in the Hypoglycaemic Range
timeFrame: 10 days
Locations:
city: Norwich
country: United Kingdom
facility: University of East Anglia
state: Norfolk
Study officials:
affiliation: University of East Anglia
name: Katharina Mattishent, PhD
role: PRINCIPAL_INVESTIGATOR
References: