CGM (Continuous Glucose Monitoring) Use in Diagnosis of Spontaneous and Reactive Hypoglycaemia
NCT ID: NCT04452396
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2019-12-01
2023-01-31
Brief Summary
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Use of CGM to aid treatment optimisation in spontaneous or reactive hypoglycaemia
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
Phase 1 - CGM monitoring of people with suspected spontaneous/reactive hypoglycaemia phase 2 - CGM monitoring of patients with medically managed spontaneous/reactive hypoglycaemia
DIAGNOSTIC
NONE
Study Groups
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patients
patients undergoing CGM monitoring
use of continuous glucose monitoring
Patients will wear a CGM device whilst undergoing diagnostic testing for reactive/spontaneous hypoglycaemia and then optimisation of anti-hypoglycaemic medication.
Interventions
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use of continuous glucose monitoring
Patients will wear a CGM device whilst undergoing diagnostic testing for reactive/spontaneous hypoglycaemia and then optimisation of anti-hypoglycaemic medication.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
90 Years
ALL
No
Sponsors
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Barts & The London NHS Trust
OTHER
Responsible Party
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Locations
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St Bartholomew's Hospital, dept of endocrinology
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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265405
Identifier Type: -
Identifier Source: org_study_id