How Common is Hypoglycaemia in Older People With Diabetes Who Fall?
Primary Purpose
Diabetes, Hypoglycaemia
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Continuous glucose monitoring (Dexcom G6)
Sponsored by
About this trial
This is an interventional other trial for Diabetes
Eligibility Criteria
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.
Sites / Locations
- University of East AngliaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Continuous glucose monitoring
Arm Description
Continuous Glucose Monitoring Device for up to 10 days
Outcomes
Primary Outcome Measures
Proportion of participants with captured hypoglycaemia; within that group, the time spent in the hypoglycaemic range
Secondary Outcome Measures
Overall Time in Range
Emergency department re-attendances and/or hospital re-admissions for falls, fractures, heart attacks, ischaemic strokes and death within 30 days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05470842
Brief Title
How Common is Hypoglycaemia in Older People With Diabetes Who Fall?
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of East Anglia
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypoglycaemia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-centre, single arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Continuous glucose monitoring
Arm Type
Experimental
Arm Description
Continuous Glucose Monitoring Device for up to 10 days
Intervention Type
Device
Intervention Name(s)
Continuous glucose monitoring (Dexcom G6)
Other Intervention Name(s)
Dexcom G6
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of participants with captured hypoglycaemia; within that group, the time spent in the hypoglycaemic range
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall Time in Range
Time Frame
6 months
Title
Emergency department re-attendances and/or hospital re-admissions for falls, fractures, heart attacks, ischaemic strokes and death within 30 days
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katharina Mattishent, PhD
Phone
+441603456161
Email
k.mattishent@uea.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Yoon K Loke, MD
Phone
+441603456161
Email
y.loke@uea.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharina Mattishent, PhD
Organizational Affiliation
University of East Anglia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of East Anglia
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR47TJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katharina Mattishent, PhD
Email
k.mattishent@uea.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
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How Common is Hypoglycaemia in Older People With Diabetes Who Fall?
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