CLEAR
Study title
Closed Loop and Education for hypoglycaemia Awareness Restoration (CLEAR)
Background
Hypoglycaemia unawareness is a condition where people with type 1 diabetes can’t feel low blood glucose levels, which means someone else might need to provide assistance to normalise that person’s blood glucose. This is because their body’s response to low blood sugar has weakened. The purpose of this study is to learn how to improve awareness of hypoglycaemia.
Study aims
This study will use different types of education and devices to see if they can help you become more aware of when your blood sugar is low and reduce the number of times that you experience hypoglycaemia.
Study summary
The CLEAR study is a research study being carried out in the USA, Australia and the United Kingdom. The main study is composed of Year 1 and Year 2.
In Year 1, depending on whether or not you already use a hybrid closed loop insulin delivery system (HCL pump), you will be randomly placed (like flipping a coin) to one of four groups:
1. You will begin to use a study HCL pump
OR
2. You will receive an educational course called MyHypoCompass (MyHC) to help you better recognise, understand and manage your hypoglycaemia.
OR
3. You will continue to use an HCL pump (study or yours) and will receive an educational course (MyHC) help you better recognise, understand and manage your hypoglycaemia.
OR
4. You will continue to use an HCL pump (study or yours).
For Year 2, you will be assigned to either continuing your usual care, continuing to use a study HCL pump, starting a study HCL pump or continuing your treatment with the addition of a different psycho-educational course called HARPdoc. The purpose of the second year of treatment is to establish whether the effects of treatment are maintained over a longer time, whether there is any further benefit from longer treatment, and whether a combination of treatments can give someone more benefit.
Watch our video for more information.
Study progress
Recruiting research participants.
Funding and sponsorship
The CLEAR study is a research study being carried out in the USA, Australia and the United Kingdom. It is funded by the National Institutes of Health (NIH), part of the US Department of Health and Human Services, which is the their medical research agency. The Penn State University (PSU) is the sponsor of the study. CLEAR stands for Closed Loop and Education for hypoglycaemia Awareness Restoration. In the UK, Sheffield Teaching Hospitals NHS Foundation Trust and University Hospitals of Leicester NHS Trust are working together, in collaboration with the University of Sheffield and University of Leicester, to perform the study.
Registration number (Clinicaltrials.gov): NCT06325202
Study publications
None yet.
Data Protection
Research team
Principal Investigator: Prof Pratik Choudhary
Project Manager: Mahfuja Ahmed
For more information, please contact: uhl-tr.t1andtechresearch@nhs.net or call: 0116 258 8575