Diabetes, Hypoglycaemia
Conditions
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.
Interventions
DEVICEContinuous 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.
Sponsors
University of East Anglia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single-centre, single arm study
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Captured Hypoglycaemia | 10 days | Number of patients who experienced more than 15 minutes of hypoglycaemia within the 10-day sensor lifespan and data capture period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Time in Range (Average) | 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. |
| Emergency Department Re-attendances and/or Hospital Re-admissions for Falls, Fractures, Heart Attacks, Ischaemic Strokes and Death Within 30 Days | 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
| Measure | Time frame | Description |
|---|---|---|
| For Participants Who Experienced Hypoglycaemic Events, the Amount of Time (Minutes) They Were in the Hypoglycaemic Range | 10 days | Number of minutes the blood glucose was within the hypoglycaemic range in the participants who experienced hypoglycaemic events. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continuous Glucose Monitoring Continuous Glucose Monitoring Device for up to 10 days
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. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Continuous Glucose Monitoring |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Region of Enrollment United Kingdom | 12 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 1 / 11 |
Outcome results
Primary
Proportion of Participants With Captured Hypoglycaemia
Number of patients who experienced more than 15 minutes of hypoglycaemia within the 10-day sensor lifespan and data capture period.
Time frame: 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitoring | Proportion of Participants With Captured Hypoglycaemia | 3 Participants |
Secondary
Emergency Department Re-attendances and/or Hospital Re-admissions for Falls, Fractures, Heart Attacks, Ischaemic Strokes and Death Within 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.
Time frame: 30 days
Population: Completers analysed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitoring | Emergency Department Re-attendances and/or Hospital Re-admissions for Falls, Fractures, Heart Attacks, Ischaemic Strokes and Death Within 30 Days | 1 Participants |
Secondary
Overall Time in Range (Average)
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.
Time frame: 10 days
Population: Completers of the monitoring period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring | Overall Time in Range (Average) | 52 percentage of Time in Range | Standard Deviation 23 |
Other Pre-specified
For Participants Who Experienced Hypoglycaemic Events, the Amount of Time (Minutes) They Were in the Hypoglycaemic Range
Number of minutes the blood glucose was within the hypoglycaemic range in the participants who experienced hypoglycaemic events.
Time frame: 10 days
Population: Subgroup of participants who were found to have hypoglycaemic events
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Continuous Glucose Monitoring | For Participants Who Experienced Hypoglycaemic Events, the Amount of Time (Minutes) They Were in the Hypoglycaemic Range | 40 minutes |