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

RecruitingNAAges 14 Years - 26 YearsAllUniversity of Colorado, Denver
NCT06575790 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Simple Meal Bolusing
  • Carbohydrate counting
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Where

1 site
Barbara Davis Center
Aurora, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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