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COMPLETEDNA

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

NCT05528770•Marc Breton

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.

Detailed Description

Study participants will be admitted to the hotel for a 4-night study, receiving the two sessions in random order: 1) Fully control loop (FCL) with the bolus priming system (BPS) activated, 2) FCL without the BPS, with a 24-hour washout period in between. During the admission, participants will receive structured meals and have blood glucose control followed to compare time in range 70-180 mg/dL between Controller sessions. After the first 24 hour period on the first FCL approach (BPS vs. no BPS,) that the participant has been randomized to, there will be a 24 hour challenge period before shifting to the other randomized approach; during this session participants will undergo further testing of the control algorithm, including meal challenges and a high-intensity interval training bout.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18.0 and ≤65 years old at time of consent
•2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
•3. Currently using insulin for at least six months
•4. Currently using insulin pump for at least three months
•5. Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
•6. Current regular exercise (e.g. walk, bike, jog) and be able to participate in a high intensity interval training activity.
•7. Access to internet and willingness to upload data during the study as needed
•8. For females, not currently known to be pregnant or breastfeeding
•9. 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.
•10. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
+7 more criteria

Exclusion Criteria

•1. History of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
•2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
•3. Pregnancy or intent to become pregnant during the trial
•4. Currently being treated for a seizure disorder
•5. Planned surgery during study duration.
•6. Treatment with meglitinides/sulfonylureas at the time of hotel study.
•7. 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.
•8. 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
•9. 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)
•10. Clinically significant electrocardiogram (ECG) at time of Screening, as interpreted by the study medical physician.
+8 more criteria

Locations (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

Key Dates

Start Date

October 20, 2022

Primary Completion Date

January 13, 2023

Completion Date

January 15, 2023

Last Updated

September 8, 2025

Enrollment

ACTUAL participants

Conditions

Type 1 Diabetes

Interventions

FCL+BPS

DEVICE

FCL

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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