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Patients will wear a CGM device whilst undergoing diagnostic testing for reactive/spontaneous hypoglycaemia and then optimisation of anti-hypoglycaemic medication.

use of continuous glucose monitoring

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

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

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.

2 phases to study. Patients can enter at start of either phase and start phase 2 at the end of phase 1.

Phase 1 - CGM monitoring of people with suspected spontaneous/reactive hypoglycaemia phase 2 - CGM monitoring of patients with medically managed spontaneous/reactive hypoglycaemia

Phase 1 - (diagnostic) The CGM device will be blinded to the patient and physician until investigations into hypoglycaemia are complete phase 2 - (treatment optimisation) The CGM device will be blinded to the patient and physician for the first 10 days of treatment, medication will be optimised and the patient will continue with CGM in an unblinded way for up to 20 further days to aid further treatment optimisation

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

Continuous Glucose Monitoring: An Evaluation of Impact on Improving the Efficiency of Diagnostic Processes and Enhancing Patient Safety in the Management of Reactive and Spontaneous Hypoglycaemia

outpatient - CGM findings reflect patient's fingerprick glucose readings

* Episodes of true hypoglycaemia (glucose measurement \<4, \<3.0, \<2.2mmol/L as decided by finger prick glucose testing) are captured by the CGM device

inpatient - CGM findings reflect patient's fingerprick glucose readings

* Episodes of true hypoglycaemia (glucose measurement \<4, \<3.0, \<2.2mmol/L, as decided by finger prick glucose testing) are captured by the CGM device Inpatient - 72 hour fast - CGM device calls hypoglycaemia (glucose measurement \<4, \<3.0, \<2.2mmol/L) when fingerprick/lab glucoses also do

blinded phase - CGM findings reflect patient's fingerprick glucose readings- any episodes of true hypoglycaemia (as decided by fingerprick glucose testing) are captured by CGM device unblinded phase - CGM recordings help with titration of anti hypoglycaemic medications and this reduces overall incidence of hypoglycaemic episodes or duration of time spent in hypoglycaemic range (\<4, \<3.0, \<2.2 mmol/L)

To determine whether CGM systems accurately record hypoglycaemia and can be used in this context

Barts & The London NHS Trust

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CGM (Continuous Glucose Monitoring) Use in Diagnosis of Spontaneous and Reactive Hypoglycaemia	NCT04452396	Hypoglycemia, R... Hypoglycaemia N... Hypoglycemia No... Hypoglycemia Un... Insulinoma Insulinoma; Mal... Insulin Hypogly... Insulin Resista... Spontaneous Hyp... Neuro Endocrine...	use of continuo...	18 Years - 90 Years	Barts & The London NHS Trust
CGM (Continuous Glucose Monitoring) Use in Diagnosis of Spontaneous and Reactive Hypoglycaemia	NCT04452396	Hypoglycemia, R... Hypoglycaemia N... Hypoglycemia No... Hypoglycemia Un... Insulinoma Insulinoma; Mal... Insulin Hypogly... Insulin Resista... Spontaneous Hyp... Neuro Endocrine...	use of continuo...	18 Years - 90 Years	Barts & The London NHS Trust

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