Extended Bolus for Meals in a Closed-loop System

NCT ID: NCT05454891

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2025-09-30

Brief Summary

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Extended bolus of insulin then standard bolus of insulin

Intervention Type: DRUG

For a standardized HFHP breakfast, participants will receive an extended meal bolus of insulin on the first morning and a standard meal bolus of insulin on the second morning of the study.

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

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

Group Type: EXPERIMENTAL

Standard bolus of insulin then extended bolus of insulin

Intervention Type: DRUG

For a standardized HFHP breakfast, participants will receive a standard bolus of insulin on the first morning and an extended bolus of insulin on the second morning of the study.

Interventions

Extended bolus of insulin then standard bolus of insulin

For a standardized HFHP breakfast, participants will receive an extended meal bolus of insulin on the first morning and a standard meal bolus of insulin on the second morning of the study.

Intervention Type: DRUG

Standard bolus of insulin then extended bolus of insulin

For a standardized HFHP breakfast, participants will receive a standard bolus of insulin on the first morning and an extended bolus of insulin on the second morning of the study.

Intervention Type: DRUG

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laya Ekhlaspour, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Laya Ekhlaspour, MD

Role: CONTACT

laya.ekhlaspour@ucsf.edu

415-514-8531

Rebecca Wesch

Role: CONTACT

Rebecca.wesch@ucsf.edu

(415) 476-5984

Facility Contacts

Rebecca Wesch

Role: primary

Other Identifiers

5K23DK121942-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

58992

Identifier Type: -

Identifier Source: org_study_id