Study on the Effect of Influenza Vaccine on Preserving Beta Cell Function in Early Type 1 Diabetes Patients

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What is this study about?

The INVITED trial is a clinical study focused on Type 1 diabetes, a condition where the body’s immune system attacks the cells in the pancreas that produce insulin. This study is investigating whether the Vaxigrip Tetra vaccine, which is a type of flu shot, can help preserve the function of these insulin-producing cells in people who have recently been diagnosed with Type 1 diabetes. The vaccine is given as an injection into the muscle.

The purpose of the study is to see if getting the flu vaccine can help maintain the body’s ability to produce insulin in people with early Type 1 diabetes. Participants in the study will receive either the flu vaccine or a placebo. The study will track changes in the body’s ability to produce insulin over a period of 12 months. This will be measured by looking at levels of a substance called C-peptide, which indicates how well the pancreas is working. Other factors, such as blood sugar levels and insulin needs, will also be monitored.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the vaccine. The study aims to provide valuable information on whether the flu vaccine can be a helpful treatment in managing early Type 1 diabetes by preserving the function of insulin-producing cells.

1 joining the trial

Upon joining the INVITED trial, you will be required to provide written informed consent. This consent must be given by your parents or legal guardian if you are under 18 years of age.

You must be between 7 and 18 years old and have been recently diagnosed with type 1 diabetes to participate in this trial.

2 initial assessment

An initial assessment will be conducted to establish baseline measurements. This includes measuring your fasting C-peptide levels, which help assess your body’s ability to produce insulin.

Your HbA1c levels, which indicate your average blood sugar levels over the past three months, will also be recorded.

3 vaccination

You will receive the Vaxigrip Tetra vaccine, which is an influenza vaccine given as an intramuscular injection. This vaccine is intended to help determine if it can preserve your body’s ability to produce insulin.

The vaccine is administered as a single dose using a pre-filled syringe.

4 follow-up assessments

Follow-up assessments will occur at various intervals to monitor changes in your fasting C-peptide levels and HbA1c levels over time.

These assessments will take place at 6 months and 12 months after the initial vaccination.

5 continuous glucose monitoring

At 12 months, your glucose levels will be continuously monitored over a 14-day period. This will help assess the time your glucose levels remain within the target range of 3.9-10.0 mmol/L.

The variation in your glucose levels will also be measured to understand how stable your blood sugar levels are over this period.

6 final evaluation

A final evaluation will be conducted to assess any changes in your insulin requirements. This will be measured as the total insulin dose per kilogram of body weight per day, averaged over the last 14 days.

The trial aims to determine if the influenza vaccination has helped preserve your body’s ability to produce insulin over the course of 12 months.

Who Can Join the Study?

Patients who have been hospitalized with newly diagnosed type 1 diabetes.
Both male and female participants are eligible.
Participants must be 7 years old or older but younger than 18 years.
Written informed consent is required from parents or a legal guardian. This means that the parents or legal guardian must agree in writing for the child to participate in the study.

Who Cannot Join the Study?

Patients who do not have Type 1 diabetes cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are not willing to receive an influenza vaccination cannot participate.
Patients with any other medical condition that might interfere with the study cannot participate.
Patients who are pregnant or planning to become pregnant during the study cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have a history of severe allergic reactions to vaccines cannot participate.
Patients who have received an influenza vaccine within the last 6 months cannot participate.
Patients who have a compromised immune system cannot participate.
Patients who are unable to comply with the study procedures cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Steno Diabetes Center Copenhagen	Herlev	Denmark
Slagelse Hospital	Slagelse	Denmark
Aalborg University Hospital	Aalborg	Denmark
Holbaek Sygehus	Holbæk	Denmark
Region Midtjylland	Aarhus	Denmark
Region Sjaelland	Holbæk	Denmark
Nykoebing F Sygehus	Nykobing	Denmark
Region Midtjylland	Randers	Denmark
Akbcom Upqnjmwjxb Hzwojxtr	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.09.2022

Trial locations

Investigated drugs:

Influenza Vaccine is a type of vaccine designed to protect against the influenza virus, commonly known as the flu. In this clinical trial, the vaccine is being used to see if it can help preserve the function of certain cells in the pancreas, called beta cells, in people who are in the early stages of type 1 diabetes. These beta cells are important because they produce insulin, which helps control blood sugar levels. The goal is to find out if getting the flu vaccine can help keep these cells working better for longer in people with type 1 diabetes.

Type 1 diabetes – Type 1 diabetes is a chronic condition where the pancreas produces little or no insulin, a hormone needed to allow sugar (glucose) to enter cells to produce energy. The disease typically begins in childhood or young adulthood, but it can develop at any age. It progresses as the immune system mistakenly attacks and destroys insulin-producing beta cells in the pancreas. Over time, this leads to high blood sugar levels, which can cause various symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. As the disease advances, it requires careful management of blood sugar levels through lifestyle adjustments and monitoring.

Trial ID:

2022-500906-17-01

Protocol code:

INVITED-2022

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effect of Influenza Vaccine on Preserving Beta Cell Function in Early Type 1 Diabetes Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?