Extended Bolus for Meals in a Closed-loop System

• ClinicalTrials.gov Identifier: NCT05454891
• Recruitment Status: Recruiting
• First Posted: July 12, 2022
• Last Update Posted: April 10, 2024
• Sponsor: University of California, San Francisco
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): University of California, San Francisco

Tracking Information

• First Submitted Date: June 24, 2022
• First Posted Date: July 12, 2022
• Last Update Posted Date: April 10, 2024
• Actual Study Start Date: July 15, 2022
• Estimated Primary Completion Date: July 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 8, 2022)

Glucose Area Under Curve [AUC] [ Time Frame: Baseline and 5 hours post-bolus ]

Area under the curve between glucose trace and starting glucose (mg/dL* hour)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 8, 2022)

• Percentage of time between 70-180 mg/dL [ Time Frame: Baseline and 5 hours post-bolus ]
  Percentage of time spent between 70-180 mg/dl based on Continuous Glucose Monitor (CGM) values
• Percentage of time in hypoglycemic range (defined as < 70 mg/dL) [ Time Frame: Baseline and 5 hours post-bolus ]
  Percentage of time spent with blood sugar less than 70 mg/dL based on Continuous Glucose Monitor (CGM) values
• Average glucose [ Time Frame: Baseline and 5 hours post-bolus ]
  Average glucose value based on Continuous Glucose Monitor (CGM) values
• Percentage of time in hyperglycemic range (defined as ≥180 mg/dL); [ Time Frame: Baseline and 5 hours post-bolus ]
  Percentage of time spent with blood sugar higher than 180 mg/dL based on Continuous Glucose Monitor (CGM) values
• Insulin dosage [ Time Frame: Baseline and 5 hours post-bolus ]
  Total insulin received during 5 hrs ( manual bolus as well as automated)
• Time to target [ Time Frame: Baseline and 5 hours post-bolus ]
  Time spent till blood glucose returns to range
• Time to baseline [ Time Frame: Baseline and 5 hours post-bolus ]
  Time spent till blood glucose returns to baseline
• Time to peak glucose [ Time Frame: Baseline and 5 hours post-bolus ]
  Time spent till blood glucose reaches the maximum value after meal
• Change in glucose [ Time Frame: Baseline and 5 hours post-bolus ]
  The difference between baseline to max glucose value
• Peak glucose concentration [ Time Frame: Baseline and 5 hours post-bolus ]
  Max blood glucose
• Percentage of time between 70-140 mg/dL [ Time Frame: Baseline and 5 hours post-bolus ]
  Percent of glucose readings from CGM system between 70-140 mg/dL per unit of time

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Type 1 Diabetes

Intervention

• Drug: 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.
• 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.

Study Arms

• Experimental: 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.
  Intervention: Drug: Extended bolus of insulin then standard bolus of insulin
• Experimental: 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.
  Intervention: Drug: Standard bolus of insulin then extended bolus of insulin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 8, 2022): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2024
• Estimated Primary Completion Date: July 30, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years to 19 Years (Child, Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Laya Ekhlaspour, MD; 415-514-8531; laya.ekhlaspour@ucsf.edu

Contact: Rebecca Wesch; (415) 476-5984; Rebecca.wesch@ucsf.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05454891
• Other Study ID Numbers: 58992; 5K23DK121942-02 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of California, San Francisco
• Original Responsible Party: Same as current
• Current Study Sponsor: University of California, San Francisco
• Original Study Sponsor: Same as current
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Laya Ekhlaspour, MD; University of California, San Francisco

• PRS Account: University of California, San Francisco
• Verification Date: April 2024