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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Norfolk
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Norwich, Norfolk, United Kingdom, NR47TJ
- University of East Anglia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Continuous glucose monitoring
Continuous Glucose Monitoring Device for up to 10 days
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
10 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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10 days
|
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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
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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.
|
30 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
10 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Katharina Mattishent, PhD, University of East Anglia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- v2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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