Insulin Resistance Clinical Trial
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
Verified date | December 2023 |
Source | Barts & The London NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Use of CGM to determine diagnosis in possible spontaneous or reactive hypoglycaemia. Use of CGM to aid treatment optimisation in spontaneous or reactive hypoglycaemia
Status | Terminated |
Enrollment | 7 |
Est. completion date | January 31, 2023 |
Est. primary completion date | March 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | St Bartholomew's Hospital, dept of endocrinology | London |
Lead Sponsor | Collaborator |
---|---|
Barts & The London NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
up to 5 days prior to admission for hypoglycaemia investigations | |
Primary | 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 |
up to 5 days in hospital during investigations for hypoglycaemia | |
Primary | 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) | up to 30 days | |
Secondary | 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 | up to 10 days (study arm 1) or up to 30 days (study arm 2) |
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