Overview
This study aims to evaluate whether the use of an extended bolus will improve glucose control with high-fat high protein meals using a closed-loop system. The new knowledge gained from this study may provide a method to allow for the proper administration of insulin over an extended period to mitigate the risk of prolonged hyperglycemia or early hypoglycemia.
Eligibility
Inclusion Criteria
- Age between 13 and 19 years old, A1C > 6% at screening
- Diagnosed with type 1 diabetes for at least one year
- Total daily dose (TDD) of insulin ≥ 0.3 units/kg/day
- Currently using the Control IQ closed-loop system
- Willing to abide by meal recommendations and study procedures
- Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF
- Use an Android or Apple smartphone
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
- Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff
- Parent/guardian proficient in reading and writing English
- Live in the United States, with no plans to move outside the United States during the study period
Exclusion Criteria
- A1C >10%
- One or more episodes of severe hypoglycemia or DKA requiring ER visit or hospitalization within the past three months
- Used non-insulin anti-diabetic medication within the last 30 days other than metformin
- Known history of gastroparesis, seizure disorder, adrenal insufficiency, or ongoing renal or hepatic disease
- Pregnancy or lactation
- Untreated or unstable hypothyroidism
- Currently undergoing cancer treatment or systemic treatment with steroids
- Untreated or inadequately treated mental illness
- Current alcohol abuse
- Current illness that would interfere with participation in the study
- Delayed gastric emptying or any concurrent conditions that can be associated with delayed gastric emptying or altered digestion; and the use of any medication that affects gastric emptying
- Celiac Disease