Search / Trial NCT06230276

Managing of Missed Meal Bolus by HCL Systems

Launched by ZDENĚK ŠUMNÍK · Jan 19, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how different types of hybrid closed-loop (HCL) systems for managing diabetes can affect blood sugar levels when a meal bolus (a dose of insulin given before eating) is missed. The trial will involve children and adolescents aged 9 to 18 years who have type 1 diabetes and are already using one of three common HCL systems: Medtronic MiniMed 780G, Tandem Control-IQ, or Ypsomed CamAPS. Researchers want to see if the type of HCL system or the type of insulin used makes a difference in how blood sugar levels change after a missed meal bolus.

To participate, children need to have been diagnosed with type 1 diabetes for at least two years, weigh more than 30 kilograms, and use continuous glucose monitoring (a device that tracks blood sugar levels) more than 70% of the time. Participants will be given a specific amount of nutrition for breakfast on eight different days, and on half of those days, they will not take the insulin dose they usually would. This trial is currently recruiting participants, and those interested should be prepared to provide informed consent for their involvement.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • children with type 1 diabetes (CwD) 9.00-18.99 years old
  • use of continuous glucose monitoring (CGM) \>70% of the time 14 days before a regular check-up in the outpatient clinic
  • HCL use (MiniMed 780G, Tandem Control-IQ or Ypsomed CamAPS) \>3 months
  • duration of T1D \>2 years
  • baseline HbA1c level \<58 mmol/mol (7.5%)
  • weight \> 30 kilograms
  • without any medication influencing glycemia (f.e. gliflozins, systemic corticosteroids...)
  • signed informed consent form with the study

About Zdeněk šumník

Zdeněk Šumník is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on developing effective therapeutic solutions, the organization collaborates with a network of healthcare professionals and research institutions to conduct high-quality clinical trials. Zdeněk Šumník emphasizes ethical practices, patient safety, and adherence to regulatory standards, ensuring that all studies contribute valuable insights to the medical community while fostering a culture of transparency and collaboration. Through its rigorous approach to clinical research, Zdeněk Šumník aims to improve patient outcomes and drive progress in the field of healthcare.

Locations

Prague, , Czechia

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0