Whilst the COVID-19 pandemic continues, hospitals are discouraging well patients from visiting the hospital so that they do not catch COVID-19 there. Also, in many hospitals the doctors, nurses and facilities usually used for clinical trials are being re-directed to supporting sick patients or performing research only on COVID-19. This means that at many sites it is not possible for children in clinical trials to attend the hospital for check ups and to receive their study drug treatments.
As result of these changes, the three clinical trials for children and young people running in the Consortium – USTEKID, ITAD and PROTECT have all been paused for new recruitment and arrangements are being put in place to allow people to continue to be monitored in the study, if necessary involving study treatments given at home. Your study team will keep you up to date on any changes.
All the trial teams and their monitoring committees are also continually checking to ensure that there is no extra risk for young people continuing in the studies. It is re-assuring that despite evidence that older people with type 2 diabetes are at increased risk from COVID-19, the latest information from China and Italy suggests that children and young people with type 1 diabetes are at no greater risk than other children and indeed no cases of severe COVID-19 in children with type 1 diabetes have been reported:
Keep Calm: Under 25s With Diabetes Not Hospitalized Due to COVID-19
The International Society for Pediatric and Adolescent Diabetes has recent released the following statement:
COVID-19 in children with diabetes Resources
Continuing in any clinical trial is always voluntary. Please discuss any concerns you have with your study team. If you decide to not continue with the study treatments, your wish will be fully respected, you do not have to give a reason, no-one will be upset and it will not affect the ongoing medical care you receive. If you decide to continue, the data you provide will continue to be of great value in developing new treatments for the future.