Using extended insulin boluses to improve glucose control in type 1 diabetes
Postprandial Glucose Control Using an Extended Bolus for High-fat High Protein Meals in a Closed-loop System in Patients With Type 1 Diabetes
This study is testing if giving insulin in a special way during high-fat, high-protein meals can help teenagers with type 1 diabetes keep their blood sugar levels more stable.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 13 Years to 19 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05454891 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an extended bolus of insulin in managing glucose levels during high-fat, high-protein meals in adolescents with type 1 diabetes using a closed-loop system. Participants will receive either an extended bolus followed by a standard bolus or vice versa to determine which method provides better glucose control. The goal is to reduce the risk of prolonged hyperglycemia or early hypoglycemia by optimizing insulin delivery over an extended period. The study will involve participants aged 13 to 19 who are currently using the Control IQ closed-loop system.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 13 to 19 with type 1 diabetes, an A1C greater than 6%, and currently using a Control IQ closed-loop system.
Not a fit: Patients with an A1C greater than 10% or recent severe hypoglycemia or diabetic ketoacidosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved glucose management for adolescents with type 1 diabetes, particularly during challenging meal scenarios.
How similar studies have performed: Other studies have explored insulin delivery methods in diabetes management, but this specific approach using extended boluses in a closed-loop system is relatively novel.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
San Francisco, California
- University of California San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Laya Ekhlaspour, MD — University of California, San Francisco
- Study coordinator: Laya Ekhlaspour, MD
- Email: laya.ekhlaspour@ucsf.edu
- Phone: 415-514-8531
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.