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

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Barts & The London NHS Trust
Updated on 19 February 2024
medical therapy

Summary

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 18-90 years
Treatment use of continuous glucose monitoring
Clinical Study IdentifierNCT04452396
SponsorBarts & The London NHS Trust
Last Modified on19 February 2024

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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