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

Sponsors

Lead Sponsor: Barts & The London NHS Trust

Source Barts & The London NHS Trust
Brief 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

Detailed 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.

Overall Status Recruiting
Start Date December 1, 2019
Completion Date March 1, 2021
Primary Completion Date November 18, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
study arm 1 - diagnosing hypoglycaemic episodes using Continuous Glucose Monitoring of interstitial fluid as a proxy marker of blood glucose up to 5 days prior to admission for hypoglycaemia investigations
study arm 1 - diagnosing hypoglycaemic episodes (glucose measurement <4mmol/L) using Continuous Glucose Monitoring of interstitial fluid as a proxy marker of blood glucose up to 5 days in hospital during investigations for hypoglycaemia
study arm 2 - using Continuous Glucose Monitoring of interstitial fluid as a proxy marker of blood glucose to optimise hypoglycaemia treatment in patients with an established diagnosis of spontaneous or reactive hypoglycaemia up to 30 days
Secondary Outcome
Measure Time Frame
assessing concordance between CGMS and lab/finger prick glucose testing up to 10 days (study arm 1) or up to 30 days (study arm 2)
Enrollment 30
Condition
Intervention

Intervention Type: Device

Intervention Name: use of continuous glucose monitoring

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

Arm Group Label: patients

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Healthy Volunteers: No

Overall Contact

Last Name: Scott Akker, MBBS

Phone: 0207 377 7000

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: St Bartholomew's Hospital, dept of endocrinology Scott Akker, MBBS 02073777000 [email protected]
Location Countries

United Kingdom

Verification Date

August 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: patients

Type: Experimental

Description: patients undergoing CGM monitoring

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: 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

Primary Purpose: Diagnostic

Masking: None (Open Label)

Masking Description: 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

Source: ClinicalTrials.gov