Managing of Missed Meal Bolus by HCL Systems

Diabetes Mellitus, Type 1 Clinical Trial

— NOELLE  

Official title:

How do the Currently Available HCL Systems Manage Missed Meal Bolus? The Comparison of Glycemic Outcomes After Missed Meal Bolus Between MiniMed 780G, Tandem Control-IQ and Ypsomed CamAPS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06230276
• Other study ID #: 1B_23N01
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Motol
• Contact: Alžbeta Šantová, MD
• Phone: +420 773 707 270
• Email: alzbetkasantova[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 1, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Czechia	Motol University Hospital	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Zdenek Šumník

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.	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)	4 hours after a meal
Secondary	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	insulin analogs - aspart and ultra-rapid lispro	4 hours after a meal
Secondary	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	insulin analogs - aspart and ultra-rapid lispro	4 hours after a meal
Secondary	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	insulin analogs - aspart and ultra-rapid lispro	4 hours after a meal
Secondary	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	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)	4 hours after a meal
Secondary	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.	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)	4 hours after a meal