NCT06230276

Brief Summary

The goal of this interventional study is to compare glycemic outcomes after missed meal bolus in children and adolescents with type 1 diabetes (CwD) treated by one of the three most common used types of hybrid closed loop (HCL) systems - Medtronic MiniMed 780G, Tandem Control-IQ, Ypsomed CamAPS. The main questions it aims to answer are:

  • 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

December 17, 2023

Last Update Submit

January 19, 2024

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Difference in an area under the curve of a glucose concentration change 4 hours after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems.

    4 hour after a meal

Secondary Outcomes (8)

  • Difference in a maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems.

    4 hours after a meal

  • Difference in time to maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems.

    4 hours after a meal

  • Difference in CGM parameters 4 hours after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems.

    4 hours after a meal

  • Difference in an area under the curve of a glucose concentration change 4 hours after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using different types of insulin analogs

    4 hours after a meal

  • Difference in a maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using two different types of insulin analogs

    4 hours after a meal

  • +3 more secondary outcomes

Study Arms (1)

Intervention with and without premeal bolus

EXPERIMENTAL
Other: enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast

Interventions

enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfastOTHER

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.

Intervention with and without premeal bolus

Eligibility Criteria

Age9 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Motol University Hospital

Prague, 15006, Czechia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Enteral NutritionBreakfast

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition TherapyMealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Alžbeta Šantová, MD

CONTACT

+420 773 707 270alzbetkasantova@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of the Department of Pediatrics

Study Record Dates

First Submitted

December 17, 2023

First Posted

January 30, 2024

Study Start

January 1, 2024

Primary Completion

September 30, 2024

Study Completion

December 1, 2024

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations

CZ(1)