Managing of Missed Meal Bolus by HCL Systems (NOELLE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Other: enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alžbeta Šantová, MD; Phone Number: +420 773 707 270; Email: alzbetkasantova@gmail.com

Study Locations

• Czechia
  • Prague, Czechia, 15006
    • Recruiting
    • Motol University Hospital
    • Contact: Alžbeta Šantová, MD; Phone Number: +420773707270; Email: alzbetkasantova@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention with and without premeal bolus

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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.	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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Zdeněk Šumník

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 1B_23N01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No