Description
- 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
Ages Eligible for Study:
13 Years to 19 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No