Simplified Meal Boluses vs. Carbohydrate Counting for Type 1 Diabetes

This study is looking at how well two different ways of managing meals work for adolescents and young adults (ages 14-26) with type 1 diabetes who use a hybrid closed loop (HCL) system. You would either use a "Simplified Meal Bolusing" method, where you pick pre-set numbers for small, medium, or large meals, or "Carbohydrate Counting," where you accurately count carbohydrates for all meals and snacks. The main goal is to see which method helps you stay in your target blood sugar range (Time in Range) for up to 12 weeks. The study is currently recruiting 40 participants.

Study design
This is a randomized crossover study, meaning participants will try both methods for a period of time. It involves 40 participants at a single location.
What's involved
You would use the simple meal bolus plan for 4 weeks and then precise carbohydrate counting for 4 weeks. You would also provide your continuous glucose monitor and pump data, and complete surveys.
Compensation
Not stated in the trial record.
Follow-up
Your Time in Range will be measured during the study period, up to 12 weeks.

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NCT06575790

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

Recruiting
NAAges 14–26InterventionalTreatment
University of Colorado, Denver
~40 participants
Updated 2024-12-10 on ClinicalTrials.gov
What's tested:Simple Meal BolusingCarbohydrate counting

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time in Range
Measured over Measured during the duration of the study period, up to 12 weeks
Type 1 Diabetes
1 sites across 1 states
Colorado1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Time in RangeMeasured during the duration of the study period, up to 12 weeks

    % of time sensor glucose values are between 70-180 mg/dL