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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06575790
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
14 Years - 26 Years
Healthy Volunteers
Not accepted

Interventions

  • Simple Meal Bolusing — BEHAVIORAL
    Participants will enter pre-determined numbers for small, medium, or large carbohydrate meals rather than using precise carbohydrate counting
  • Carbohydrate counting — BEHAVIORAL
    Participants will be instructed to enter accurate carbohydrate counts to the best of their ability for all meals and snacks

Study Details

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

Key Dates

Start date
Nov 25, 2024
Status verified
Dec 2024
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Barbara Davis CenterAuroraColorado80045
Alexandra Sawyer, MD, MPH
[email protected]
720-724-2323
Alexandra Sawyer, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Barbara Davis Center· Aurora, CO

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