Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A single-center pilot study to establish a novel hypoglycemic clamp procedure to assess the time to spontaneous recovery from hypoglycemia in people with and without diabetes

This research aims to understand how the body recovers from very low blood sugar (hypoglycemia) in people with and without type 2 diabetes. They're using a new method to carefully control blood sugar levels. Participants receive insulin to gently lower their blood sugar, and then researchers observe how much insulin is needed for this, and importantly, how long it takes for the body to naturally bring blood sugar back up. The study will compare these responses between those with and without diabetes to learn more about this important aspect of managing blood sugar.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Medical University Of Graz

Enrolment target

Start

11 Jun 2025

Type 2 Diabetes Mellitus

What is this study about?

This study is designed to help us understand more about how our bodies deal with low blood sugar, also known as hypoglycemia. This is particularly important for people with diabetes, as sometimes their blood sugar can drop too low. Researchers are testing a new way to safely create and then observe low blood sugar levels in both people with and without type 2 diabetes.

The main aim is to see how much insulin is needed to lower blood sugar to certain levels, and then, crucially, how quickly a person's body can naturally recover from very low blood sugar. By comparing these responses between people with and without diabetes, we can learn valuable information about how these processes might differ. This knowledge could eventually help doctors better understand and manage low blood sugar episodes.

They're using a medication called NovoRapid, which is a fast-acting insulin, to carefully control blood sugar during the study. This is an early-stage study (Phase I and II), meaning they are checking if the new method for testing is safe and working as expected before it can be used more widely in future research.

Key takeaways

The study investigates how bodies recover from low blood sugar (hypoglycemia).
It involves people with and without type 2 diabetes.
Researchers use insulin (NovoRapid) to carefully lower blood sugar.
The goal is to understand how much insulin is needed and how quickly blood sugar naturally recovers.
This research could help improve how low blood sugar is understood and managed.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 or older. Both men and women are welcome to participate.

They are looking for people with type 2 diabetes and also people who do not have diabetes to take part. This allows researchers to compare how different bodies react to low blood sugar.

More specific details about your health will be checked by the study team to make sure it's safe for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have type 2 diabetes, or do you not have diabetes?
Are you able to attend appointments at the study center?
Are you willing to have your blood sugar closely monitored and receive insulin?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would visit the research center. During these visits, a fast-acting insulin medication called NovoRapid will be given to you to carefully lower your blood sugar. Medical staff will closely monitor your blood sugar levels throughout the process. They will observe how much insulin is needed to reach specific blood sugar targets and how long it takes for your body to naturally recover from low blood sugar. This will involve multiple blood sugar checks. If your blood sugar doesn't recover on its own or drops too low, you'll be given glucose (sugar) to bring it back up. The total number of visits and the overall duration of your participation will be explained by the study team.

Potential risks and benefits

Potential benefits of taking part include helping researchers better understand how our bodies handle low blood sugar, which could lead to improved care for people with diabetes in the future. The main risk involves experiencing low blood sugar, but this will be carefully managed by trained medical staff who will be prepared to give you glucose if needed to quickly bring your blood sugar back to a safe level. You will be closely monitored throughout the study. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Austria

Common questions

What is 'low blood sugar'?

Low blood sugar, or hypoglycemia, is when the amount of sugar (glucose) in your blood drops to a level that's too low for your body to work properly. This can make you feel weak, shaky, or confused.

Why is this study important for people with type 2 diabetes?

Understanding how people with type 2 diabetes recover from low blood sugar can help doctors manage the condition better and predict who might be at higher risk or need closer monitoring.

What is NovoRapid?

NovoRapid is a type of insulin medication that works quickly to lower blood sugar levels. It's commonly used by people with diabetes.

Will I be safe if my blood sugar gets too low?

Yes, your safety is the top priority. The medical team will be closely monitoring your blood sugar, and they are trained and ready to give you sugar (glucose) if your blood sugar drops to an unsafe level or doesn't recover on its own.

Is this a new medicine?

No, NovoRapid is an approved insulin. This study is testing a new way of observing how the body reacts to insulin and recovers from low blood sugar, not a new medicine itself.