- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05528770
Evaluation of The Postprandial Impact of Automated Priming Bolus for Full Closed Loop Insulin Delivery (Rocket-BPS)
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22903
- University of Virginia Center for Diabetes Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- An understanding and willingness to follow the protocol and signed informed consent
- Willingness to follow COVID-19 protocols in place at the time of study.
Exclusion Criteria:
- 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
- Musculoskeletal or other condition that limits participation in exercise portion of study
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
- Positive Covid-19 test result
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Full closed-loop (FCL) with Bolus Priming System (BPS) followed by FCL without BPS
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:
|
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
Other Names:
The automated insulin delivery system does not include the Bolus Priming System, and therefore does not automatically command priming boluses.
Other Names:
|
Active Comparator: Full closed-loop (FCL) without Bolus Priming System (BPS) followed by FCL with BPS
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:
|
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
Other Names:
The automated insulin delivery system does not include the Bolus Priming System, and therefore does not automatically command priming boluses.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Daytime Time-in-range
Time Frame: 18 hours
|
Percent of CGM values falling between 70 and 180 mg/dL during daytime (6am to midnight)
|
18 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Overall Time-in-range
Time Frame: 24 hours
|
Percent of CGM values falling between 70 and 180 mg/dL
|
24 hours
|
Difference in Daytime Time-below-range
Time Frame: 18 hours
|
Percent of CGM values falling below 70mg/dL during daytime (6am to midnight)
|
18 hours
|
Difference in Overall Time-below-range
Time Frame: 24 hours
|
Percent of CGM values falling below 70mg/dL
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sue Brown, MD, University of Virginia Center for Diabetes Technology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 220261
- R01DK129553 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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