The Impact of Daily Carbohydrate Intake on Glycemic Control in Children and Adolescents With Type… (NCT05866900) | Clinical Trial Compass
CompletedNot Applicable
The Impact of Daily Carbohydrate Intake on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-loop System
Italy, Slovenia347 participantsStarted 2023-05-15
Plain-language 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. 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.
Who can participate
Age range
7 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time in range (%)
Timeframe: 6 months
2
Time above range level 1 (%)
Timeframe: 6 months
3
Time above range level 2 (%)
Timeframe: 6 months
4
Time below range level 1 (%)
Timeframe: 6 months
5
Time below range level 2 (%)
Timeframe: 6 months
6
Mean sensor glucose (mg/dl or mmol/L)
Timeframe: 6 months
7
Coefficient of variation (%)
Timeframe: 6 months
Trial details
NCT IDNCT05866900
SponsorUniversity of Ljubljana, Faculty of Medicine