Clinical trial NCT05454891: Extended Bolus for Meals in a Closed-loop System
Official title: Postprandial Glucose Control Using an Extended Bolus for High-fat High Protein Meals in a Closed-loop System in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Type 1 Diabetes
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomly assigned (1:1) in blocks of two to the order in which they receive the two premeal insulin boluses: extended followed by standard bolus or a standard followed by extended bolus.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Glucose Area Under Curve [AUC]
timeFrame: Baseline and 5 hours post-bolus
Secondary outcomes:
measure: Percentage of time between 70-180 mg/dL
timeFrame: Baseline and 5 hours post-bolus
measure: Percentage of time in hypoglycemic range (defined as < 70 mg/dL)
timeFrame: Baseline and 5 hours post-bolus
measure: Average glucose
timeFrame: Baseline and 5 hours post-bolus
measure: Percentage of time in hyperglycemic range (defined as ≥180 mg/dL);
timeFrame: Baseline and 5 hours post-bolus
measure: Insulin dosage
timeFrame: Baseline and 5 hours post-bolus
measure: Time to target
timeFrame: Baseline and 5 hours post-bolus
measure: Time to baseline
timeFrame: Baseline and 5 hours post-bolus
measure: Time to peak glucose
timeFrame: Baseline and 5 hours post-bolus
measure: Change in glucose
timeFrame: Baseline and 5 hours post-bolus
measure: Peak glucose concentration
timeFrame: Baseline and 5 hours post-bolus
measure: Percentage of time between 70-140 mg/dL
timeFrame: Baseline and 5 hours post-bolus
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Laya Ekhlaspour, MD
role: PRINCIPAL_INVESTIGATOR
References: