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

NCT06575790 | Recruiting

• 1 other identifier: 24-1159
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time in Range

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

  Measured during the duration of the study period, up to 12 weeks

Secondary Outcomes (3)

• Hypoglycemia

  Measured during the duration of the study period, up to 12 weeks

• Hyperglycemia

  Measured during the duration of the study period, up to 12 weeks

• Feasibility, acceptability, and self-reported mealtime insulin bolus burden

  Given 3 times during the duration of the study period, up to 12 weeks

Study Arms (2)

Simple Meal Bolusing

EXPERIMENTAL

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.

Behavioral: Simple Meal Bolusing

Precise Carbohydrate counting

ACTIVE COMPARATOR

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.

Behavioral: Carbohydrate counting

Interventions

Simple Meal Bolusing BEHAVIORAL

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

Simple Meal Bolusing

Carbohydrate counting BEHAVIORAL

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

Precise Carbohydrate counting

Eligibility Criteria

• Age: 14 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Barbara Davis Center

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Alexandra Sawyer, MD, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 28, 2024
• Study Start: November 25, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)