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

NCT04452396 | Terminated DMC

• 1 other identifier: 265405
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

Hypoglycemia, Reactive; Hypoglycaemia Night; Hypoglycemia Non-Diabetic; Hypoglycemia Unawareness; Insulinoma; Insulinoma; Malignant, Pancreas; Insulin Hypoglycemia; Insulin Resistance; Spontaneous Hypoglycemia; Neuro Endocrine Tumours

Keywords

hypoglycaemia; insulinoma

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• 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)

Study Arms (1)

patients

EXPERIMENTAL

patients undergoing CGM monitoring

Device: use of continuous glucose monitoring

Interventions

use of continuous glucose monitoring DEVICE

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

patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

St Bartholomew's Hospital, dept of endocrinology

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Hypoglycemia; Insulinoma; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Adenoma, Islet Cell; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: June 30, 2020
• Study Start: December 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: January 31, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

GB (1)