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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Hypoglycaemia
• Intervention / Treatment: Device: Continuous glucose monitoring (Dexcom G6)

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katharina Mattishent, PhD; Phone Number: +441603456161; Email: k.mattishent@uea.ac.uk
• Study Contact Backup: Name: Yoon K Loke, MD; Phone Number: +441603456161; Email: y.loke@uea.ac.uk

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR47TJ
      • University of East Anglia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Continuous glucose monitoring; Continuous Glucose Monitoring Device for up to 10 days

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.; Other Names: Dexcom G6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of East Anglia
• Investigators: Principal Investigator: Katharina Mattishent, PhD, University of East Anglia

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Actual): September 22, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemia
• Other Study ID Numbers: v2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes