Extended Bolus for Meals in a Closed-loop System

University of California San Francisco (UCSF)

Status and phase: Enrolling; Phase 4

Conditions: Type 1 Diabetes

Treatments: Drug: Extended bolus of insulin then standard bolus of insulin; Drug: Standard bolus of insulin then extended bolus of insulin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05454891

5K23DK121942-02 (U.S. NIH Grant/Contract)

58992

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 13 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

High Fat High Protein (HFHP) Meal- extended then standard insulin bolus arm

Experimental group

Description:

Subjects will receive extended meal bolus for breakfast on the first day and standard meal bolus on the second day of the study.

Treatment:

Drug: Extended bolus of insulin then standard bolus of insulin

High Fat High Protein (HFHP) Meal- standard then extended insulin bolus arm

Experimental group

Description:

Subjects will receive standard meal bolus for breakfast on the first day and extended meal bolus on the second day.

Treatment:

Drug: Standard bolus of insulin then extended bolus of insulin