DiaBall Study

Together with the Bayreuth Center of Sport Science and Prof Dr Moser’s team, FC Diabetes e.V. is conducting an observational study on the influence of the ‘K1ck Without Limit’ football cup on the glucose progression of players with type 1 diabetes (T1D).
Prof Moser and Ulrike Thurm look after many competitive athletes with T1D in Germany and Austria as part of Challange – D, including our patron Sandra Starke, and have already gained a lot of experience in the connection between sport and diabetes in adults. Unfortunately, there is still far too little information about children and adolescents with T1D in connection with sport.

The DiaBall study aims to fill this gap. It is the first study of its kind in the world and will provide important information about how safely and effectively children and adolescents with T1D can control their blood glucose levels at multi-day football camps.

There is no direct personal benefit to you from taking part in the study. However, you will be making a valuable contribution to diabetes research and helping not only yourself, but also people with T1D around the world to play sports safely and effectively. We hope that the results of this study will improve treatment in the medium term and, in particular, be incorporated into insulin pump algorithms.

Procedure

The study consists of an observation period (= tournament from 25 to 27 October) and two comparison periods (three days before and three days after the tournament). Blood glucose levels during the camp will be compared to those before and after the camp in order to detect short and long term changes.
Only your blood glucose history will be ‚monitored‘ by your blood glucose meter, your insulin doses (pump, pen), when you train and play (tournament schedule, sport mode of the pump) or how many carbohydrates you eat during a hypo. The trial team won’t tell you when to do what. You do everything pretty well and independently anyway 🙂
At the end of the study (30 October), you will be asked to export your glucose values and insulin doses and send them to the study team. This may sound complicated, but it is not. Our study team will help you or your parents with this, as they have a lot of experience with the different systems.

If you have any questions about your treatment, you can always contact our diabetes team. Please also tell your coach or your parents if you have a hypo or if your value is too high.

If you have any questions about the study, please contact Mathias Walter. You can do this at almost any time before, during and after the tournament.

Entry requirements

  • You wear a glucose sensor,
  • you write down any special features, and
  • you and your parents sign the consent form.

As you can see, there is ‘actually’ nothing to do that you are hopefully not already doing 😉.

Documentation

As you may forget one or two things, it is important for the study that you write down the following points over the next few days and especially during the tournament. Your parents will certainly help you with this:

  • If you have an insulin pump, you enter almost everything into the pump anyway. Please continue to do so.
  • If you have a hypo, please also write down how much carbohydrate you eat and when. If you use an app for this, enter it into the app.
  • If you take your pump off before a match, please stop insulin delivery and start again when you put it back on.
  • Write down the times when you do not wear your pump (e.g. when you go to the swimming pool).
  • It would also be helpful if you could write down your actual training and match times. We have a tournament schedule that we use for this purpose. However, we don’t know if you will not be able to play or if you will be replaced early, for example because your blood glucose is too low or too high.

The trial team can provide a template for you to fill in to minimise the burden on you or your parents.

Privacy Policy

You may want to know what information we collect from you and how we protect it. Your data is very important to us and we adhere strictly to European data protection regulations. That’s why FC Diabetes only receives your data and forwards it immediately and in encrypted form to the University of Bayreuth, where it is stored in encrypted form. In addition, we separate your personal data from the measured values (glucose history, insulin doses) and store them securely on different computers. This means that they are pseudonymised and no one can link them back to you except the study management.

What exactly is needed for the study? The following list may seem quite extensive. However, it is the only way to systematically analyse the causes of hypos (including nocturnal or postprandial hypos).

  • Personal Data:
    • Name, date of birth
    • Language, city, country (exact address not important)
    • Sex, height, weight
    • Email address for queries or data exchange
  • Therapeutic data:
    • Insulin type(s)
    • Sensor type
    • Pump type, if used
    • HBA1c and/or time in target range (TIR) prior to study and whether measured by physician or calculated from last 14 days
    • Glucose data from the sensor system (curves or values including boluses & basal rate)
    • (Electronic) diary with all relevant entries from 22.10. to 30.10.2024 incl.
      • Hypo/Hyper treatment (glucose too low or too high)
      • Sensor and catheter changes, or when the last sensor was inserted before the start of the tournament
      • Match periods, special rest periods, other sporting activities (e.g. running from hotel to sports centre, swimming pool)
      • Pump disconnection and reconnection
        Pump failure, kinked catheter, etc.
      • Change or adjustment of basal rate or KE factors
      • Time difference if pump and/or telephone are not time-synchronised

The responsible ethics committee of the University of Bayreuth issued a positive opinion (application no.: 24-047) for this study on 27 September 2024. 🙂

Take part now!

We hope that you will not be overwhelmed by all the information and that you will still want to make an important contribution to safe sport with diabetes by taking part.

If you would like to take part, please read and complete the consent form with your parents, sign it with your parents and return it to diaball@fcdiabetes.de.
You can also sign the declaration of participation with us during the tournament. We will have plenty of copies and will be happy to discuss the details with you.
Don’t hesitate to contact us if you have any questions. Just send an email or message to Mathias Walter or call him on +49 176 20185994.

We look forward to your participation and the progress we can make with you in this study 🙂