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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes, Hypoglycaemia

Intervention / Treatment
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* Device: Continuous glucose monitoring (Dexcom G6)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single-centre, single arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous glucose monitoring<br>Continuous Glucose Monitoring Device for up to 10 days | Device: Continuous glucose monitoring (Dexcom G6)<br>* 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.<br>* Other names: Dexcom G6;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with captured hypoglycaemia; within that group, the time spent in the hypoglycaemic range |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Time in Range |  | 6 months | 
| Emergency department re-attendances and/or hospital re-admissions for falls, fractures, heart attacks, ischaemic strokes and death within 30 days |  | 6 months |