How Common is Hypoglycaemia in Older People With Diabetes Who Fall?
- Conditions
- DiabetesHypoglycaemia
- Interventions
- Device: Continuous glucose monitoring (Dexcom G6)
- Registration Number
- NCT05470842
- Lead Sponsor
- University of East Anglia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Continuous glucose monitoring Continuous glucose monitoring (Dexcom G6) Continuous Glucose Monitoring Device for up to 10 days
- Primary Outcome Measures
Name Time Method Proportion of Participants With Captured Hypoglycaemia 10 days Number of patients who experienced more than 15 minutes of hypoglycaemia within the 10-day sensor lifespan and data capture period.
- Secondary Outcome Measures
Name Time Method Overall Time in Range (Average) 10 days 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.
Emergency Department Re-attendances and/or Hospital Re-admissions for Falls, Fractures, Heart Attacks, Ischaemic Strokes and Death Within 30 Days 30 days 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.
Trial Locations
- Locations (1)
University of East Anglia
🇬🇧Norwich, Norfolk, United Kingdom