CGM (Continuous Glucose Monitoring) Use in Diagnosis of Spontaneous and Reactive Hypoglycaemia

Barts & The London NHS Trust

Status

Terminated

Conditions

Hypoglycemia, Reactive

Insulinoma

Hypoglycaemia Night

Hypoglycemia Non-Diabetic

Hypoglycemia Unawareness

Insulinoma; Malignant, Pancreas

Insulin Resistance

Spontaneous Hypoglycemia

Neuro Endocrine Tumours

Insulin Hypoglycemia

Treatments

Device: use of continuous glucose monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT04452396

265405

Details and patient eligibility

About

Use of CGM to determine diagnosis in possible spontaneous or reactive hypoglycaemia.

Use of CGM to aid treatment optimisation in spontaneous or reactive hypoglycaemia

Full description

The human body's blood sugar levels are tightly controlled by the hormone insulin, produced by the pancreas. If the pancreas produces too much insulin, then the blood sugar will fall to low levels (hypoglycaemia). Insulin overproduction can happen as a result of the body misreading a change in blood sugar levels after eating (such as after obesity surgery) or through tumours of the pancreas which overproduce insulin (insulinomas).

Hypoglycaemia can cause subtle symptoms such as tiredness, poor concentration, or dizziness and if untreated more severe symptoms including fits, coma and death. Low blood sugars can go unnoticed at night and if levels fall frequently, people can lose their ability to notice subtle symptoms.

People suspected of having hypoglycaemia require a series of investigations to try and reproduce a low blood sugar under controlled conditions. This often requires an admission to hospital for a few days and multiple finger pricks to test the blood sugar - which patients often find painful. If low blood sugars caused by too much insulin are confirmed then medical treatment is started in the first instance, with surgery possibly following later. The only way to check whether these medications are working is by home fingerprick glucose measurements. If people have low sugars at night or have lost their ability to notice symptoms of low blood sugar, it is very difficult to be sure that the medical treatment is working.

The investigators plan to use continuous glucose monitoring probes to measure patient's blood sugar prior to and during admission for formal investigation for hypoglycaemia (alongside conventional fingerprick and blood testing). This might allow us to exclude hypoglycaemia as a cause of their symptoms, avoiding lengthy admissions.

The investigators will also use this technology (alongside fingerprick testing) to test how well medical treatment is working in patients with proven hypoglycaemia.

Enrollment

7 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

phase 1 - under investigation for possible/probable hypoglycaemia
phase 2 - on medical therapy for established hypoglycaemia
Must be Able and willing to give informed consent. No vulnerable adults will be included.
Must be Aged >18 years

Can be;

Any ethnicity
Any socio economic group
Either conventional gender, or non-binary.

Exclusion criteria

Must not be unwilling or unable to give consent
Must not be unable to speak sufficient English to give consent and understand study requirements
Must not be Aged<18 or >90 years
Must not be lack capacity to consent
Must not have an underlying hepatic condition
Must not have a current excessive alcohol consumption (men regularly consuming >50 units/week, women >35 units/week)
Must not have Diabetes Mellitus
Must not be currently using Diabetic medication or insulin
Must not be currently pregnant
Must not be on haemo or peritoneal dialysis