Skip to main content
OpenTrials
Completed

NCT Number: NCT05470842

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of East Anglia

Norwich, Norfolk, NR47TJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous glucose monitoring (Dexcom G6)

Device

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.

Other names: Dexcom G6

Primary outcomes

  1. Proportion of Participants With Captured Hypoglycaemia

    Time frame: 10 days

    Number of patients who experienced more than 15 minutes of hypoglycaemia within the 10-day sensor lifespan and data capture period.

Secondary outcomes

  1. Overall Time in Range (Average)

    Time frame: 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.

  2. Emergency Department Re-attendances and/or Hospital Re-admissions for Falls, Fractures, Heart Attacks, Ischaemic Strokes and Death Within 30 Days

    Time frame: 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.

Other outcomes

  1. For Participants Who Experienced Hypoglycaemic Events, the Amount of Time (Minutes) They Were in the Hypoglycaemic Range

    Time frame: 10 days

    Number of minutes the blood glucose was within the hypoglycaemic range in the participants who experienced hypoglycaemic events.

Sponsors and collaborators

Lead sponsor

University of East Anglia

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 22, 2022
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.