Diabetes Mellitus, Type 1CHOco-AIDNCT05866900
The Impact of Daily Carbohydrate Intake on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-loop System
An observational study of Diabetes Mellitus, Type 1, run by University of Ljubljana, Faculty of Medicine at 2 sites in 2 countries.
Trial summary
Lifestyle factors, including diet, play an important role in the achievement of glycemic targets in patients with diabetes, even with the use of automated insulin delivery (AID) systems. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- MiniMed 780G with SmartGuard activated
- Type of treatment
- Medical device
- How many people
- 347 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 May 2023to 31 Oct 2023
- Phase
- Observational
- 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 7 to 18 years
- All sexes
- Child, Adult
Study population: Participants will be recruited from electronical records of two Pediatric Diabetes departments located in Slovenia and Italy
Who may be able to join
- Patients with type 1 diabetes
- Patients aged 7-18 years
- Patients using Medtronic MiniMed 780G with SmartGuard activated
- Patients whose informed consent has been obtained
- >70% CGM data during observational period
Who cannot join
- Patients with partial clinical remission according to the Hvidovre Study Group definition
- Concomitant treatment with steroids or other drugs known to interfere with blood glucose levels
- Previous diagnosis of psychological or eating disorders
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site
1Department of Human Pathology in Adult and Developmental Age "Gaetano Barresi," University ofMessina
Messina
About this study
Official title: The Impact of Daily CarboHydrate Intake on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-loop System (Medtronic MiniMed 780G): a Multi-center Real-world Observational Study
Lifestyle factors, including diet, play an important role in the achievement of glycemic targets in patients with diabetes, even with the use of automated insulin delivery (AID) systems. Advanced hybrid closed-loop systems (AHCL), by implementing innovative and powerful control algorithms, have been shown to improve the post-meal glycemic control in their users through the delivery of automatic correction boluses. However, data about the influence of the daily amount of carbohydrate intake on glycemic outcomes in youth with type 1 diabetes using AHCL are missing. Therefore, this study will evaluate the association between daily carbohydrate intakes and meal patterns on glycemic control of young people living with type 1 diabetes using an AHCL system (Medtronic MiniMed 780G; Medtronic, Northridge, California) under real-life conditions.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- MiniMed 780G with SmartGuard activated
- Keywords
- MiniMed 780G, automated insulin delivery, nutrition, diet, time in range, insulin pump
- 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.
MiniMed 780G with SmartGuard activatedDevice
The MiniMed 780G system consists of a MiniMed 780G Insulin Pump connected to Guardian 4 Sensor or Guardian 3 Sensor, using an automated insulin delivery algorithm called SmartGuard.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range (%)
Time spent with sensor glucose between 70 and 180 mg/dl (3.9 and 10 mmol/L)
Measured: 6 months
Time above range level 1 (%)
Time spent with sensor glucose between 180 and 250 mg/dl (10.1 and 13.9 mmol/L)
Measured: 6 months
Time above range level 2 (%)
Time spent with sensor glucose > 250 mg/dl (13.9 mmol/L)
Measured: 6 months
Time below range level 1 (%)
Time spent with sensor glucose between 54 and 70 mg/dl (3.0 and 3.8 mmol/L)
Measured: 6 months
Time below range level 2 (%)
Time spent with sensor glucose < 54 mg/dl (3.0 mmol/L)
Measured: 6 months
Mean sensor glucose (mg/dl or mmol/L)
Measured: 6 months
Coefficient of variation (%)
Measured: 6 months
Secondary outcomes (3)
BMI Z-score
Measured: Baseline, 3 months, 6 months
Weight Z-score
Measured: Baseline, 3 months, 6 months
Height Z-score
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start15 May 2023
- Primary completion31 Aug 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana, Faculty of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Messina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866900
- Sponsor's protocol ID
- CHOco-AID
- Acronym
- CHOco-AID
- Status last verified
- May 2023
- First submitted
- 10 May 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Bombaci B, Hropot T, Bratina N, Smigoc Schweiger D, Passanisi S, Salzano G, Di Candia F, Lombardo F, Battelino T, Dovc K. Daily Carbohydrate Entries and Glycemic Outcomes Following Automated Insulin Delivery System Initiation in Youth With Type 1 Diabetes: A Real-World Multinational Longitudinal Study. Diabetes Care. 2025 Aug 1;48(8):1434-1437. doi: 10.2337/dc25-0283.
PubMed 40478457
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Daily CarboHydrate Intake on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-loop System (Medtronic MiniMed 780G): a Multi-center Real-world Observational Study
- ClinicalTrials.gov ID
- NCT05866900
- Acronym / sponsor ID
- CHOco-AID / CHOco-AID
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- MiniMed 780G, automated insulin delivery, nutrition, diet, time in range, insulin pump
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- University of Ljubljana, Faculty of MedicineUniversity, hospital or other
- Collaborators
- University of Messina
- Study start
- 15 May 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 19 May 2023 (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.
Lifestyle factors, including diet, play an important role in the achievement of glycemic targets in patients with diabetes, even with the use of automated insulin delivery (AID) systems. Advanced hybrid closed-loop systems (AHCL), by implementing innovative and powerful control algorithms, have been shown to improve the post-meal glycemic control in their users through the delivery of automatic correction boluses. However, data about the influence of the daily amount of carbohydrate intake on glycemic outcomes in youth with type 1 diabetes using AHCL are missing. Therefore, this study will evaluate the association between daily carbohydrate intakes and meal patterns on glycemic control of young people living with type 1 diabetes using an AHCL system (Medtronic MiniMed 780G; Medtronic, Northridge, California) under real-life conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Participants will be recruited from electronical records of two Pediatric Diabetes departments located in Slovenia and Italy
Key inclusion criteria (5 listed)
- Patients with type 1 diabetes
- Patients aged 7-18 years
- Patients using Medtronic MiniMed 780G with SmartGuard activated
- Patients whose informed consent has been obtained
- >70% CGM data during observational period
Key exclusion criteria (3 listed)
- Patients with partial clinical remission according to the Hvidovre Study Group definition
- Concomitant treatment with steroids or other drugs known to interfere with blood glucose levels
- Previous diagnosis of psychological or eating disorders
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 |
|---|---|---|
| MiniMed 780G with SmartGuard activatedThe MiniMed 780G system consists of a MiniMed 780G Insulin Pump connected to Guardian 4 Sensor or Guardian 3 Sensor, using an automated insulin delivery algorithm called SmartGuard. | Device | – |
Primary outcome
Time in range (%)
Time frame: 6 months
Time spent with sensor glucose between 70 and 180 mg/dl (3.9 and 10 mmol/L)
Time above range level 1 (%)
Time frame: 6 months
Time spent with sensor glucose between 180 and 250 mg/dl (10.1 and 13.9 mmol/L)
Time above range level 2 (%)
Time frame: 6 months
Time spent with sensor glucose > 250 mg/dl (13.9 mmol/L)
Time below range level 1 (%)
Time frame: 6 months
Time spent with sensor glucose between 54 and 70 mg/dl (3.0 and 3.8 mmol/L)
Time below range level 2 (%)
Time frame: 6 months
Time spent with sensor glucose < 54 mg/dl (3.0 mmol/L)
Mean sensor glucose (mg/dl or mmol/L)
Time frame: 6 months
Coefficient of variation (%)
Time frame: 6 months
3 secondary outcomes
BMI Z-score
Time frame: Baseline, 3 months, 6 months
Weight Z-score
Time frame: Baseline, 3 months, 6 months
Height Z-score
Time frame: Baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Results publication: PubMed 40478457Bombaci B, Hropot T, Bratina N, Smigoc Schweiger D, Passanisi S, Salzano G, Di Candia F, Lombardo F, Battelino T, Dovc K. Daily Carbohydrate Entries and Glycemic Outcomes Following Automated Insulin Delivery System Initiation in Youth With Type 1 Diabetes: A Real-World Multinational Longitudinal Study. Diabetes Care. 2025 Aug 1;48(8):1434-1437. doi: 10.2337/dc25-0283.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by University of Ljubljana, Faculty of Medicine at 2 sites in 2 countries.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Slovenia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (%) (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05866900, which also lists 1 linked publication.
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 23 Jun 2026.