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Using Simplified Meal Boluses Versus Carbohydrate Counting in Adolescents With Hybrid Closed Loop Systems

Using Simplified Meal Boluses Versus Carbohydrate Counting in Adolescents With Hybrid Closed Loop Systems: A Randomized Crossover Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
14 Years to 26 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will: Use the simple meal bolus plan for 4 weeks."
  • "Do precise carbohydrate counting for 4 weeks."
  • "Provide their continuous glucose monitor and pump data Take surveys about the experience of meal bolusing during the study"
  • "At the first study visit, patients will upload their pump/CGM data, take pre-study surveys, and review carbohydrate counting or simple meal boluses."
  • "Both groups will be instructed to use their systems as they typically would for 4 weeks with the exception of what is entered for carbohydrates for meal boluses."
  • "Participants will have a final study visit to upload data and take post-study surveys."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

The goal of this trial is to evaluate blood sugar control in patients with type 1 diabetes when using a simple meal bolus strategy (small, medium, large meals) compared to carbohydrate counting when on a hybrid closed loop system. The main question it aims to answer are: What is the blood sugar time in range when using simple meal boluses versus carbohydrate counting? Participants will: Use the simple meal bolus plan for 4 weeks. Do precise carbohydrate counting for 4 weeks. Provide their continuous glucose monitor and pump data Take surveys about the experience of meal bolusing during the study

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * Clinical diagnosis of T1D of at least 1 year duration * Using a commercial HCL system * Willingness to not start any new non-insulin glucose-lowering agent during trial * Willingness to participate in all study procedures * Investigator has confidence that participant can successfully operate all study devices and adhere to protocol Exclusion Criteria: * History of \>1 severe hypoglycemic event with seizure or loss of consciousness in the last 6 months or \>1 DKA event in the last 6 months not related to illness or infusion set failure * History of chronic renal disease or currently on hemodialysis, adrenal insufficiency, hypothyroidism that is not adequately treated, use of oral or injectable steroids within the last 8 weeks, or known ongoing adhesive intolerance * A condition, which in the opinion of the investigator or designee, would put the participant or study at risk * Participation in another interventional trial at the time of enrollment * Pregnancy

Study sites (1)

CO