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

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Recruiting
participants needed

30
sponsor

Barts & The London NHS Trust

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Updated on 19 February 2024

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medical therapy

Summary

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

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

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.

Details

Condition	Insulin Resistance, insulinoma, Hypoglycemia, Insulin Hypoglycemia, Hypoglycaemia Night, Hypoglycemia Non-Diabetic, Hypoglycemia Unawareness, Insulinoma; Malignant, Pancreas, Spontaneous Hypoglycemia, Neuro Endocrine Tumours
Age	18years - 90years
Treatment	use of continuous glucose monitoring
Clinical Study Identifier	NCT04452396
Sponsor	Barts & The London NHS Trust
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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

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