Comparing simple meal boluses to carbohydrate counting for blood sugar control in adolescents with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates blood sugar control in adolescents and adults with type 1 diabetes using a simplified meal bolus strategy versus traditional carbohydrate counting while on hybrid closed loop systems. Participants will follow a simple meal bolus plan for four weeks and then switch to precise carbohydrate counting for another four weeks. The study aims to assess glycemic control, feasibility, and the impact on the burden of diabetes management. By simplifying meal bolusing, the study seeks to make diabetes management more accessible for individuals with low numeracy skills.

Why it matters

Who can join: the full rules

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

Where it's running

• Barbara Davis Center
  Aurora, Colorado, United States Recruiting

Study contacts

• Study coordinator: Alexandra Sawyer, MD, MPH
• Email: alexandra.sawyer@childrenscolorado.org
• Phone: 303-724-2323

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.