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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05470842
• Other study ID #: v2
• Status: Completed
• Phase: N/A
• Start date: June 6, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 31, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Hypoglycaemia
• Hypoglycemia

Intervention

Device:
• Continuous glucose monitoring (Dexcom G6)
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.

Locations

Country	Name	City	State
United Kingdom	University of East Anglia	Norwich	Norfolk

Sponsors (1)

Lead Sponsor	Collaborator
University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with captured hypoglycaemia; within that group, the time spent in the hypoglycaemic range		6 months
Secondary	Overall Time in Range		6 months
Secondary	Emergency department re-attendances and/or hospital re-admissions for falls, fractures, heart attacks, ischaemic strokes and death within 30 days		6 months