Hypo-METRICS: Hypoglycaemia - Measurement, ThResholds and ImpaCtS

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

OTHER

NO intervention - observational study

NO intervention - observational study

Sponsors & Collaborators

• University of Southern Denmark

  collaborator OTHER

• Sheffield Teaching Hospitals NHS Foundation Trust

  collaborator OTHER

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• Ninewells Hospital

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Nordsjaellands Hospital

  collaborator OTHER

• Medical University of Graz

  collaborator OTHER

• University Hospital, Montpellier

  collaborator OTHER

• Innovative Medicines Initiative

  collaborator OTHER

• The Leona M. and Harry B. Helmsley Charitable Trust

  collaborator OTHER

• Juvenile Diabetes Research Foundation

  collaborator OTHER

• International Diabetes Federation

  collaborator OTHER

• Novo Nordisk A/S

  collaborator INDUSTRY

• Abbott Diabetes Care

  collaborator INDUSTRY

• Medtronic Diabetes

  collaborator INDUSTRY

• King's College London

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-01

Primary Completion

2022-10-31

Completion

2022-10-31

Countries

• United Kingdom

Study Locations