Clinical trial · Interventional
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
NCT04452396CI-TRIAL-00072151terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to the Covid crisis: clinical changes in staff, bed pressures and time restraints.
Summary
Brief summary (as posted)
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
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypoglycaemia Night | — | UNRESOLVED | — |
| Hypoglycemia Non-Diabetic | — | UNRESOLVED | — |
| Hypoglycemia, Reactive | — | UNRESOLVED | — |
| Hypoglycemia Unawareness | — | UNRESOLVED | — |
| Insulin Hypoglycemia | — | UNRESOLVED | — |
| Insulinoma | Pancreatic Insulinoma | ALIAS | 0.90 |
| Insulinoma; Malignant, Pancreas | Malignant Pancreatic Insulinoma | ALIAS | 0.85 |
| Insulin Resistance | — | UNRESOLVED | — |
| Neuro Endocrine Tumours | — | UNRESOLVED | — |
| Spontaneous Hypoglycemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| use of continuous glucose monitoring | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- patients
- description
- patients undergoing CGM monitoring
- interventionNames
- Device: use of continuous glucose monitoring
Primary outcomes (3)
- measure
- study arm 1 - diagnosing hypoglycaemic episodes using Continuous Glucose Monitoring of interstitial fluid as a proxy marker of blood glucose
- timeFrame
- up to 5 days prior to admission for hypoglycaemia investigations
- description
- 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
- measure
- study arm 1 - diagnosing hypoglycaemic episodes (glucose measurement <4mmol/L) using Continuous Glucose Monitoring of interstitial fluid as a proxy marker of blood glucose
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.