Evaluation of The Postprandial Impact of Automated Priming Bolus for Full Closed Loop Insulin Delivery

NCT05528770 | Completed Results FDA Device

• 2 other identifiers: 220261R01DK129553
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand the impact of the automated priming boluses on the safety and feasibility of a new fully automated AP controller.

Conditions

Type 1 Diabetes

Keywords

Continuous Glucose Monitor (CGM); Continuous subcutaneous insulin infusion (CSII); Closed Loop Control (CLC); Hybrid Closed Loop (HCL); High-intensity interval training (HIIT); Bolus Priming System (BPS); Fully Automated Closed Loop (FCL); Artificial Pancreas (AP)

Outcome Measures

Primary Outcomes (1)

• Difference in Daytime Percent Time-in-range

  Percentage of CGM values falling between 70 and 180 mg/dL during daytime (6am to midnight)

  18 hours

Secondary Outcomes (3)

• Difference in Overall Percent Time-in-range

  24 hours

• Difference in Daytime Percent Time-below-range

  18 hours

• Difference in Overall Percent Time-below-range

  24 hours

Study Arms (2)

Full closed-loop (FCL) with Bolus Priming System (BPS) followed by FCL without BPS

ACTIVE COMPARATOR

Two separate 24-hour periods during where fully closed loop (FCL) control is used with \& without the Bolus Priming system (BPS) active (BPS is designed to recognize meal ingestion \& deliver a quick priming dose of insulin prior to extreme blood sugar excursions.) These will be separated by a 24-hour challenge period which will involve further meal \& exercise challenges. During these 24-hour periods, participants will be followed for the experimental meals as part of the Study Controller Sessions to compare blood glucose control with \& without the BPS. The study meals \& activities will be standardized between study sessions. During a washout period, we will test the RocketAP system in FCL with further challenges: * A session of high-intensity interval training * A high-carbohydrate, high-fat meal * Ingestion of a bolus of simple sugar

Device: FCL+BPS; Device: FCL

Full closed-loop (FCL) without Bolus Priming System (BPS) followed by FCL with BPS

ACTIVE COMPARATOR

Two separate 24-hour periods during where fully closed loop (FCL) control is used with \& without the Bolus Priming system (BPS) active (BPS is designed to recognize meal ingestion \& deliver a quick priming dose of insulin prior to extreme blood sugar excursions.) These will be separated by a 24-hour challenge period which will involve further meal \& exercise challenges. During these 24-hour periods, participants will be followed for the experimental meals as part of the Study Controller Sessions to compare blood glucose control with \& without the BPS. The study meals \& activities will be standardized between study sessions. During a washout period, we will test the RocketAP system in FCL with further challenges: * A session of high-intensity interval training * A high-carbohydrate, high-fat meal * Ingestion of a bolus of simple sugar

Device: FCL+BPS; Device: FCL

Interventions

FCL+BPS DEVICE

The automated insulin delivery system includes the Bolus Priming System, a software automatically analyzing past continuous glucose monitoring values to trigger priming insulin bolus delivery isn the suspected presence of meal like glycemic disturbances

Also known as: Full closed-loop (FCL) with Bolus Priming System

Full closed-loop (FCL) with Bolus Priming System (BPS) followed by FCL without BPS; Full closed-loop (FCL) without Bolus Priming System (BPS) followed by FCL with BPS

FCL DEVICE

The automated insulin delivery system does not include the Bolus Priming System, and therefore does not automatically command priming boluses.

Also known as: Full closed-loop (FCL) without Bolus Priming System

Full closed-loop (FCL) with Bolus Priming System (BPS) followed by FCL without BPS; Full closed-loop (FCL) without Bolus Priming System (BPS) followed by FCL with BPS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18.0 and ≤65 years old at time of consent
• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
• Currently using insulin for at least six months
• Currently using insulin pump for at least three months
• Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
• Current regular exercise (e.g. walk, bike, jog) and be able to participate in a high intensity interval training activity.
• Access to internet and willingness to upload data during the study as needed
• For females, not currently known to be pregnant or breastfeeding
• If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
• Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
• Willingness to use the UVa closed-loop system throughout study admission
• Willingness to use personal lispro (Humalog) or aspart (Novolog) during the study admission.
• Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin/biguanides, GLP-1 receptor agonists, pramlintide, DPP-4 inhibitors, sulfonylureas and naturaceuticals)
• Willingness to eat at least 1 g/kg of carbohydrate per day during the hotel admission
• Willingness to reschedule if placed on oral steroids

You may not qualify if:

• History of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
• Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
• Pregnancy or intent to become pregnant during the trial
• Currently being treated for a seizure disorder
• Planned surgery during study duration.
• Treatment with meglitinides/sulfonylureas at the time of hotel study.
• Use of metformin/biguanides, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, or naturaceuticals with a change in dose in the past month.
• Coronary artery disease or heart failure, unless written clearance is received from a cardiologist or personal health care provider allowing clearance for high-intensity interval training and documentation of a negative stress test within the year
• History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted or previous ablation of arrhythmia without recurrence which may be permitted)
• Clinically significant electrocardiogram (ECG) at time of Screening, as interpreted by the study medical physician.
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
• Inpatient psychiatric treatment in the past 6 months
• Presence of a known adrenal disorder
• Abnormal liver function test results (Transaminase \>2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
• Uncontrolled thyroid disease

Sponsors & Collaborators

• Marc Breton: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• Moscoso-Vasquez M, Colmegna P, Barnett C, Fuller M, Koravi CLK, Brown SA, DeBoer MD, Breton MD. Evaluation of an Automated Priming Bolus for Improving Prandial Glucose Control in Full Closed Loop Delivery. Diabetes Technol Ther. 2025 Feb;27(2):93-100. doi: 10.1089/dia.2024.0315. Epub 2024 Nov 6.

  PMID: 39501832 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Manager of Clinical Research
• Organization: Center for Diabetes Technology

mc7m@uvahealth.org

434-982-0602

Study Officials

• Sue Brown, MD

  University of Virginia Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Director for Research, Center for Diabetes Technology

Model Details: Participants will be randomized to the order that they experience the use of the Bolus Priming System (BPS) in fully automated closed loop (FCL) (for 24 hours each, with a 24-hour challenge period in between): 1) with the BPS active, 2) BPS inactive.

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 6, 2022
• Study Start: October 20, 2022
• Primary Completion: January 13, 2023
• Study Completion: January 15, 2023
• Last Updated: September 8, 2025
• Results First Posted: July 9, 2024

Record last verified: 2025-08

Locations

US (1)