Hypoglycemia, ReactiveNCT04452396
CGM (Continuous Glucose Monitoring) Use in Diagnosis of Spontaneous and Reactive Hypoglycaemia
A study testing use of continuous glucose monitoring in people with Hypoglycemia, Reactive and Hypoglycaemia Night, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypoglycemia, Reactive, Hypoglycaemia Night, Hypoglycemia Non-Diabetic
- What is being tested?
- use of continuous glucose monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2019to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Bartholomew's Hospital, dept of endocrinology
London, EC1A 7BE
About this study
Official title: 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
Use of CGM to determine diagnosis in possible spontaneous or reactive hypoglycaemia.
Use of CGM to aid treatment optimisation in spontaneous or reactive hypoglycaemia
Read the 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.
- Conditions
- Hypoglycemia, Reactive, Hypoglycaemia Night, Hypoglycemia Non-Diabetic, Hypoglycemia Unawareness, Insulinoma, Insulinoma; Malignant, Pancreas
- Being tested
- use of continuous glucose monitoring
- Keywords
- hypoglycaemia, insulinoma
- Medical subject headings
- Hypoglycemia, Insulinoma, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of continuous glucose monitoringDevice
Patients will wear a CGM device whilst undergoing diagnostic testing for reactive/spontaneous hypoglycaemia and then optimisation of anti-hypoglycaemic medication.
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | patients undergoing CGM monitoring Receives: Device: use of continuous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
study arm 1 - diagnosing hypoglycaemic episodes using Continuous Glucose Monitoring of interstitial fluid as a proxy marker of blood glucose
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
Measured: 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
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
Measured: 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
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)
Measured: up to 30 days
Secondary outcomes (1)
assessing concordance between CGMS and lab/finger prick glucose testing
To determine whether CGM systems accurately record hypoglycaemia and can be used in this context
Measured: up to 10 days (study arm 1) or up to 30 days (study arm 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start1 Dec 2019
- Primary completion1 Mar 2020
- Study completion31 Jan 2023
Why it stopped: Due to the Covid crisis: clinical changes in staff, bed pressures and time restraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoglycemia, ReactiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452396
- Sponsor's protocol ID
- 265405
- Status last verified
- Dec 2023
- First submitted
- 18 Nov 2019
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04452396
- Acronym / sponsor ID
- 265405
- Conditions
- Hypoglycemia, Reactive, Hypoglycaemia Night, Hypoglycemia Non-Diabetic, Hypoglycemia Unawareness, Insulinoma, Insulinoma; Malignant, Pancreas
- Keywords
- hypoglycaemia, insulinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the Covid crisis: clinical changes in staff, bed pressures and time restraints.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Device: use of continuous glucose monitoringpatients undergoing CGM monitoring |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of continuous glucose monitoringPatients will wear a CGM device whilst undergoing diagnostic testing for reactive/spontaneous hypoglycaemia and then optimisation of anti-hypoglycaemic medication. | Device | patients |
Primary outcome
study arm 1 - diagnosing hypoglycaemic episodes using Continuous Glucose Monitoring of interstitial fluid as a proxy marker of blood glucose
Time frame: up to 5 days prior to admission for hypoglycaemia investigations
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
study arm 1 - diagnosing hypoglycaemic episodes (glucose measurement <4mmol/L) using Continuous Glucose Monitoring of interstitial fluid as a proxy marker of blood glucose
Time frame: up to 5 days in hospital during investigations for hypoglycaemia
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
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
Time frame: up to 30 days
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)
1 secondary outcome
assessing concordance between CGMS and lab/finger prick glucose testing
Time frame: up to 10 days (study arm 1) or up to 30 days (study arm 2)
Results and safety
The study was stopped early (reason given: Due to the Covid crisis: clinical changes in staff, bed pressures and time restraints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of continuous glucose monitoring in people with Hypoglycemia, Reactive and Hypoglycaemia Night, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to the Covid crisis: clinical changes in staff, bed pressures and time restraints.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
study arm 1 - diagnosing hypoglycaemic episodes using Continuous Glucose Monitoring of interstitial fluid as a proxy marker of blood glucose (time frame: up to 5 days prior to admission for hypoglycaemia investigations). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.