Diabetes Mellitus, Type 1NOELLENCT06230276
Managing of Missed Meal Bolus by HCL Systems
A study testing enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast in people with Diabetes Mellitus, Type 1, run by Zdeněk Šumník at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 9 to 19 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Motol University Hospital
Prague, 15006
Alžbeta Šantová, MD, +420773707270, alzbetkasantova@gmail.com
About this study
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
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention with and without premeal bolus | Experimental | Not described Receives: Other: enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 4 hours after a meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Jan 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zdeněk Šumník
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zdeněk Šumník, University Hospital, Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230276
- Sponsor's protocol ID
- 1B_23N01
- Acronym
- NOELLE
- Status last verified
- Jan 2024
- First submitted
- 17 Dec 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06230276
- Acronym / sponsor ID
- NOELLE / 1B_23N01
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Zdeněk ŠumníkUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention with and without premeal bolus | Experimental | Other: enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast |
Who may qualify
- Ages
- 9 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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%)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfastParticipants 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. | Other | Intervention with and without premeal bolus |
Primary outcome
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.
Time frame: 4 hour after a meal
8 secondary outcomes
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.
Time frame: 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.
Time frame: 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 frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 frame: 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 frame: 4 hours after a meal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast in people with Diabetes Mellitus, Type 1, run by Zdeněk Šumník at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alžbeta Šantová, MD (+420 773 707 270, alzbetkasantova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 4 hour after a meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.