RecruitingNAINTERVENTIONAL

Closed Loop and Education for Hypoglycemia Awareness Restoration

The CLEAR study is for adults with type 1 diabetes who struggle to feel when their blood sugar levels are dropping too low. This problem, called 'impaired awareness of hypoglycaemia' (IAH), can make managing diabetes harder and increase the risk of serious low blood sugar events. The study aims to find out if using advanced insulin pumps like Omnipod 5 or Medtronic 780G, or taking part in special education programmes (My HypoCOMPaSS or HARPdoc), can help people regain their ability to recognise these low blood sugar symptoms. Researchers want to compare these approaches to see which is most effective in making people more aware and improving their body's natural response to low blood sugar, ultimately making diabetes management safer.

At a glance

Status

Recruiting

Phase

Sponsor

Milton S. Hershey Medical Center

Enrolment target

324

Start

03 Oct 2025

Estimated completion

31 Jul 2029

Diabetes Mellitus, Type 1

What is this study about?

For many people with type 1 diabetes, knowing when your blood sugar is dropping too low is crucial. Your body usually gives you warning signs like shakiness, sweating, or confusion. However, some people, especially those who have had type 1 diabetes for a long time, find it harder to notice these symptoms. This is called 'impaired awareness of hypoglycaemia' or IAH, and it can be a real worry because it increases the risk of dangerously low blood sugar incidents.

This study, called CLEAR, wants to help. It's looking at different ways to help people get back their ability to feel these low blood sugar signs. Researchers are testing two main approaches: using advanced insulin pumps (like the Omnipod 5 or Medtronic 780G), which can automatically adjust insulin delivery, and participating in special educational courses designed to teach you more about managing low blood sugar. The aim is to see if these methods can reduce how often severe low blood sugar happens and improve your body's natural warning signals.

Experts believe that by strictly avoiding low blood sugar for a period, or by learning new ways to manage it, people can become more sensitive to the early signs again. This study is really important because it will help us understand which treatments work best for different people, including older adults who are often not included in such research. Ultimately, the goal is to find effective ways to help more people with type 1 diabetes live safer, healthier lives by improving their awareness of low blood sugar.

Key takeaways

The CLEAR study helps people with type 1 diabetes who struggle to feel low blood sugar.
It compares advanced insulin pumps and special education to improve awareness.
The aim is to reduce dangerous low blood sugar episodes.
Participants will have physical checks, questionnaires, and a controlled blood sugar test.
It helps us understand which treatments work best for different people.
You can leave the study at any time if you wish.

Who may be eligible?

This study is looking for adults aged 18 to 75 who have type 1 diabetes. You would need to have had type 1 diabetes for at least 10 years and have clear signs that you struggle to recognise when your blood sugar levels are getting too low, based on specific health scores. Your average blood sugar (HbA1c) should be below 10.5%, and you should be able to read and speak English.

There are certain health conditions or situations that would prevent someone from joining the study. For example, if you have other serious medical conditions like certain kidney or liver problems, uncontrolled heart conditions, or are undergoing cancer treatment, you likely wouldn't be able to participate. Also, if you use certain medications like steroids often, or if you are pregnant, planning to get pregnant, or breastfeeding, you wouldn't be eligible.

The researchers also need to make sure you can fully take part in all study activities. This means they would check for things like significant vision or hearing problems, or if there are major social challenges like homelessness or a lack of support that might make it hard to keep up with the study's requirements.

Quick self-check

Do I have type 1 diabetes?
Am I between 18 and 75 years old?
Have I had type 1 diabetes for at least 10 years?
Do I often not notice when my blood sugar is low?
Is my average blood sugar (HbA1c) usually below 10.5%?
Am I able to read and speak English comfortably?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in the CLEAR study, you'll first be assessed to make sure it's suitable for you. If you qualify and haven't used a hybrid closed-loop system (a type of insulin pump) before, you'll be randomly assigned to either receive one of these new pumps (Omnipod 5 or Medtronic 780G) or to take part in one of the educational programmes (My HypoCOMPaSS or HARPdoc).

Throughout the study, you'll have regular visits where doctors and nurses will check your health, blood sugar levels, and how well you're managing your diabetes. A key part of the study involves a special test called an 'experimental hypoglycaemia clamp procedure'. This is a controlled way for doctors to carefully lower your blood sugar in a safe environment to see how your body responds and how well you recognise the symptoms. There will also be questionnaires to fill out about your awareness of low blood sugars.

Your participation will involve careful monitoring and assessments over a period determined by the study design, potentially involving different stages of treatment or education. The total duration of your involvement will be clearly explained to you before you agree to join.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as improved awareness of low blood sugar, which might lead to fewer severe episodes and better overall diabetes control. You also might gain access to advanced insulin pump technology or specialised education not otherwise available. However, there are potential risks, including those associated with any changes in diabetes management, such as the possibility of low or high blood sugar, even with careful monitoring. The 'hypoglycaemia clamp' test, while done under strict medical supervision, involves deliberately lowering blood sugar, which carries inherent risks, although every precaution will be taken to ensure your safety. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (8)

University of California, San Diego
La Jolla, United States· Recruiting
AdventHealth
Orlando, United States· Recruiting
University of Kentucky
Lexington, United States· Recruiting
University of Minnesota
Minneapolis, United States· Recruiting
University of Pennsylvania
Philadelphia, United States· Recruiting
University of Melbourne
Fitzroy, Australia· Recruiting
University of Leicester
Leicester, United Kingdom· Recruiting
University of Sheffield
Sheffield, United Kingdom· Recruiting

Common questions

What is 'impaired awareness of hypoglycaemia'?

It's when you have type 1 diabetes but you don't easily or quickly recognise the signs or symptoms of your blood sugar dropping too low.

What are 'closed-loop systems'?

These are advanced insulin pumps that work with a sensor to automatically adjust your insulin dose based on your blood sugar readings, helping to keep it in range.

Will I have to pay for the pumps or education?

No, if you're selected to receive one of the interventions as part of the study, it will be provided to you without cost.

Is this study safe?

Yes, all procedures, especially those involving blood sugar changes, are conducted under strict medical supervision by experienced healthcare professionals to ensure your safety.

How long will I be in the study?

The exact duration will depend on which group you're in and the study's design, but it will be clearly explained to you before you agree to participate.

How to find out more

Abid Kazi, PhD

akazi@pennstatehealth.psu.edu 717-531-0003 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.