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

U

University of East Anglia

Status

Completed

Conditions

Diabetes
Hypoglycaemia

Treatments

Device: Continuous glucose monitoring (Dexcom G6)

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Continuous glucose monitoring
Experimental group
Description:
Continuous Glucose Monitoring Device for up to 10 days
Treatment:
Device: Continuous glucose monitoring (Dexcom G6)

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Katharina Mattishent, PhD; Yoon K Loke, MD

Data sourced from clinicaltrials.gov

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