Extended Bolus for Meals in a Closed-loop System

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jul 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how a specific method of delivering insulin, called an "extended bolus," can help people with type 1 diabetes better manage their blood sugar levels after eating meals that are high in fat and protein. The trial uses a closed-loop system, which is a type of technology that automatically adjusts insulin delivery based on real-time glucose levels. By testing this method, researchers hope to find ways to reduce the risk of high blood sugar (hyperglycemia) or low blood sugar (hypoglycemia) after meals.

To participate in the study, you need to be between 13 and 19 years old, have been diagnosed with type 1 diabetes for at least a year, and currently use the Control IQ closed-loop system. You should also have an average blood sugar level (A1C) above 6% and take a certain amount of insulin daily. Participants will be expected to follow specific meal guidelines and attend training sessions. It's important to note that this trial is looking for participants who live in the United States and can commit to the study for its duration. If you're interested, this could be a valuable opportunity to help improve diabetes care.

Gender

ALL

Eligibility criteria

• • 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