Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2024-01-01
2024-12-01
Brief Summary
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* Do the glycemic outcomes (area under the curve of glucose concentration change, maximal glucose rise from baseline, time to maximal glucose rise from baseline, CGM parameters) vary after missed meal bolus among different types of HCL systems?
* Does the type of insulin analog influence glycemic outcomes after a missed meal bolus?
Participants will have a precisely defined amount of enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast during eight different days under predetermined conditions. They will administer premeal bolus only for half of these meals.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention with and without premeal bolus
enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast
Participants who are already treated by one of the HCL systems (MiniMed 780G, Tandem Control-IQ, Ypsomed CamAPS) will have a precisely defined amount of enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast during eight different days under predetermined conditions. They will administer premeal bolus only for half of these meals.
Interventions
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enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast
Participants who are already treated by one of the HCL systems (MiniMed 780G, Tandem Control-IQ, Ypsomed CamAPS) will have a precisely defined amount of enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast during eight different days under predetermined conditions. They will administer premeal bolus only for half of these meals.
Eligibility Criteria
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Inclusion Criteria
* 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
9 Years
19 Years
ALL
No
Sponsors
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Zdeněk Šumník
OTHER
Responsible Party
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Zdeněk Šumník
Head of the Department of Pediatrics
Locations
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Motol University Hospital
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1B_23N01
Identifier Type: -
Identifier Source: org_study_id
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