NCT05454891Completed
Extended Bolus for Meals in a Closed-loop System
Postprandial Glucose Control Using an Extended Bolus for High-fat High Protein Meals in a Closed-loop System in Patients With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 24 Jun 2022
- Start date
- 15 Jul 2022
- Primary completion date
- 19 Dec 2024
- Lead sponsor
- University of California, San Francisco
- Diseases
- Type 1 diabetes
- NCT number
- NCT05454891
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 15 Jul 2022 to the primary completion date, 19 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Used non-insulin anti-diabetic medication within the last 30 days other than metformin
- Currently undergoing cancer treatment or systemic treatment with steroids
- 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
Other illness
- Known history of gastroparesis, seizure disorder, adrenal insufficiency, or ongoing renal or hepatic disease
- Untreated or inadequately treated mental illness
- Current illness that would interfere with participation in the study
- Celiac Disease
Other
- A1C \>10%
- One or more episodes of severe hypoglycemia or DKA requiring ER visit or hospitalization within the past three months
- Pregnancy or lactation
- Untreated or unstable hypothyroidism
- Current alcohol abuse
Who the study is looking for
- 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
Age in the registry: 13 years to 19 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.