Recruiting

Simplified Meal Boluses vs. Carbohydrate Counting

Sponsor:

University of Colorado, Denver

Code:

NCT06575790

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 14 - 26

Healthy Volunteers: Not accepted

Interventions

Simple Meal Bolusing

Carbohydrate counting

Study Details

Brief summary:

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

Conditions

Type 1 Diabetes

Study ID

NCT06575790

Start date

Nov 25, 2024

Status verified date

Dec, 2024

Completion date

Sep 30, 2025

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 26

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Simple Meal Bolusing

Participants will be instructed to enter a set number of carbohydrates before meals based on if they are having a small, medium, or large meal. The preset numbers for meals will be based on their average total daily dose (TDD) determined during the 2-week usual care observation period. The participants will have their insulin to carbohydrate ratios set based on the standard formula of 450/TDD for all meals initially (e.g. a child with a TDD of 50 u/day would have 450/50=9 so an I:C of 1:9). They enter a carbohydrate amount of 30 g for small meals, 60 g for regular meals, and 90 g for large meals.

active comparator: Precise Carbohydrate counting

Participants will be instructed to enter a precise carbohydrate count before meals to the best of their ability. Pump settings may be adjusted per provider discretion and typical clinical care during this time period.

Interventions

Simple Meal Bolusing

Participants will enter pre-determined numbers for small, medium, or large carbohydrate meals rather than using precise carbohydrate counting

Carbohydrate counting

Participants will be instructed to enter accurate carbohydrate counts to the best of their ability for all meals and snacks

Primary outcome measure

  • Time in Range [ Time Frame: Measured during the duration of the study period, up to 12 weeks ]

Central Contacts and Locations

Central contacts

Alexandra Sawyer, MD, MPH

303-724-2323alexandra.sawyer@childrenscolorado.org

Locations

Barbara Davis Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Alexandra Sawyer, MD, MPH

720-724-2323alexandra.sawyer@childrenscolorado.org

Principal Investigator:

Alexandra Sawyer, MD, MPH

More Information

Sponsor

University of Colorado, Denver

Last update posted

Dec 10, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-12-10.