Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of California, San Francisco
With
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Age
13–19
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Extended Bolus for Meals in a Closed-loop System
