Actively Recruiting
Using Simplified Meal Boluses Versus Carbohydrate Counting in Adolescents With Hybrid Closed Loop Systems
Led by University of Colorado, Denver · Updated on 2024-12-10
40
Participants Needed
1
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Using Simplified Meal Boluses Versus Carbohydrate Counting in Adolescents With Hybrid Closed Loop Systems
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of type 1 diabetes for at least 1 year
- Currently using a commercial hybrid closed loop insulin system
- Willing to not start any new non-insulin glucose-lowering medications during the study
- Willing to participate in all study procedures
- Investigator believes participant can operate study devices and follow the study protocol
You will not qualify if you...
- More than one severe hypoglycemic event with seizure or loss of consciousness in the last 6 months
- More than one diabetic ketoacidosis event in the last 6 months not related to illness or infusion set failure
- History of chronic kidney disease or currently on hemodialysis
- Untreated adrenal insufficiency or hypothyroidism
- Use of oral or injectable steroids within the last 8 weeks
- Known ongoing adhesive intolerance
- Any condition that would put the participant or study at risk in the opinion of the investigator
- Participation in another interventional trial at enrollment
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Barbara Davis Center
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
A
Alexandra Sawyer, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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