NCT04304963

Hypo-METRICS: Hypoglycaemia - Measurement, ThResholds and ImpaCtS

Hypo-METRICS: Hypoglycaemia - Measurement, ThResholds and ImpaCtS A Clinical Study to Determine the Optimal Threshold and Duration of Low Interstitial Glucose Events That Have an Impact on Patient Experienced Hypoglycaemia, Quality of Life and Health Economic Outcomes.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 602 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: —

Summary

Hypoglycaemia or low blood glucose, and its fear are major barriers to achieving optimal glucose control. New technology, such as continuous glucose monitors (CGM), help to better identify hypoglycaemia and develop strategies to avoid it. These devices measure glucose in the skin, rather than in the blood, and provide information not only on how low glucose is, but also for how long. Recent studies showed that over half of episodes of low glucose with these systems are not recognised by people with diabetes, and even people without diabetes have sensor values that are below the current thresholds for hypoglycaemia \[ low blood glucose\] that we measure with traditional monitors. In this study, the investigators will evaluate the impact of symptomatic as well as asymptomatic episodes of low sensor glucose on a variety of clinical, patient-related and health economic outcomes such as mood, quality of sleep and productivity. The investigators will test different levels and durations of low sensor glucose to identify the one that best matches episodes that are symptomatic to best define hypoglycaemia using these systems. The investigators will also look at factors that influence this such as sleep or activity as well as diabetes management behaviours (such as insulin dosing, carb counting, etc). At the end of this study, the investigators will be able to provide a better definition of clinically relevant low sensor glucose readings that will help inform clinical as well as academic interpretation of CGM data.

Conditions

• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Hypoglycemia
• Hypoglycemia Unawareness

Interventions

Type	Name	Description
OTHER	NO intervention - observational study	NO intervention - observational study

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2020-03-12
• Last updated: 2023-10-11

Locations

1 site across 1 country: United Kingdom