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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

Ages 14 to 26 · All sexes

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

About the 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

What is being tested

• Simple Meal Bolusing (behavioral)
• Carbohydrate counting (behavioral)

Sponsor: University of Colorado, Denver · Participants: 40 · Started: Nov 25, 2024

Contact the study team

• Alexandra Sawyer, MD, MPH · Phone: 303-724-2323

Official record on ClinicalTrials.gov — NCT06575790

Locations in the U.S.

Conditions

• Type 1 Diabetes

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.