Managing of Missed Meal Bolus by HCL Systems

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 1

• Registration Number: NCT06230276
• Lead Sponsor: Zdeněk Šumník

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-17
• Status Verified: 2024-01
• Study Start: 2024-01-01
• Study First Submitted QC: 2024-01-19
• Last Update Submitted: 2024-01-19
• Study First Posted: 2024-01-30
• Last Update Posted: 2024-01-30
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Difference in CGM parameters after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using insulin ultra-rapid lispro	4 hours after a meal	time in range TIR (3.9-10.0 mmol/L; 70-180 mg/dL) time above range level 1 TAR1 (10.1-13.9 mmol/L; 181-250 mg/dL) time above range level 2 TAR2 (\> 13.9 mmol/L; \>250 mg/dL) time below range level 1 TBR1 (3.0-3.8 mmol/L; 54-69 mg/dL) time below range level 2 TBR2 (\< 3.0 mmol/L; \<54 mg/dL) time in tight range TITR (3.9-7.8 mmol/L; 70-140 mg/dL)
Difference in CGM parameters after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using insulin aspart.	4 hours after a meal	time in range TIR (3.9-10.0 mmol/L; 70-180 mg/dL) time above range level 1 TAR1 (10.1-13.9 mmol/L; 181-250 mg/dL) time above range level 2 TAR2 (\> 13.9 mmol/L; \>250 mg/dL) time below range level 1 TBR1 (3.0-3.8 mmol/L; 54-69 mg/dL) time below range level 2 TBR2 (\< 3.0 mmol/L; \<54 mg/dL) time in tight range TITR (3.9-7.8 mmol/L; 70-140 mg/dL)
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 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	insulin analogs - aspart and ultra-rapid lispro
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 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	insulin analogs - aspart and ultra-rapid lispro
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	time in range TIR (3.9-10.0 mmol/L; 70-180 mg/dL) time above range level 1 TAR1 (10.1-13.9 mmol/L; 181-250 mg/dL) time above range level 2 TAR2 (\> 13.9 mmol/L; \>250 mg/dL) time below range level 1 TBR1 (3.0-3.8 mmol/L; 54-69 mg/dL) time below range level 2 TBR2 (\< 3.0 mmol/L; \<54 mg/dL) time in tight range TITR (3.9-7.8 mmol/L; 70-140 mg/dL)
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 using two different types of insulin analogs	4 hours after a meal	insulin analogs - aspart and ultra-rapid lispro

Trial Locations

Locations (1)

Motol University Hospital; 🇨🇿 Prague, Czechia