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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK129553 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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|
| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Overall Percent Time-in-range | Percentage of CGM values falling between 70 and 180 mg/dL | 24 hours |
| Difference in Daytime Percent Time-below-range | Percentage of CGM values falling below 70mg/dL during daytime (6am to midnight) |
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Inclusion Criteria:
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:
A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
Positive Covid-19 test result
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| Name | Affiliation | Role |
|---|---|---|
| Sue Brown, MD | University of Virginia Center for Diabetes Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | 22903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39501832 | Result | 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. |
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15 participants signed informed consent for the main study. 2 screen failed and 2 withdrew prior to randomization to arms. Results reported on 11 participants who were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
FCL+BPS: 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 FCL: The automated insulin delivery system does not include the Bolus Priming System, and therefore does not automatically command priming boluses. |
| FG001 | 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:
FCL+BPS: 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 FCL: The automated insulin delivery system does not include the Bolus Priming System, and therefore does not automatically command priming boluses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
FCL+BPS: 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 FCL: The automated insulin delivery system does not include the Bolus Priming System, and therefore does not automatically command priming boluses. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Daytime Percent Time-in-range | Percentage of CGM values falling between 70 and 180 mg/dL during daytime (6am to midnight) | Posted | Mean | Standard Deviation | percentage of CGM values | 18 hours |
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From protocol entry through last study date which is approximately one month per participant
Adverse Event definitions are the same as clinicaltrials.gov. Please see protocol for further details of adverse event reporting.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Full Closed-loop (FCL) With Bolus Priming System (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:
FCL+BPS: 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 FCL: The automated insulin delivery system does not include the Bolus Priming System, and therefore does not automatically command priming boluses. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | Vomiting induced by exercise, not device-related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Clinical Research | Center for Diabetes Technology | 434-982-0602 | mc7m@uvahealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2022 | Jan 17, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 11, 2022 | Jan 17, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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| FCL | Device | The automated insulin delivery system does not include the Bolus Priming System, and therefore does not automatically command priming boluses. |
|
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| 18 hours |
| Difference in Overall Percent Time-below-range | Percentage of CGM values falling below 70mg/dL | 24 hours |
| BG001 | 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:
FCL+BPS: 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 FCL: The automated insulin delivery system does not include the Bolus Priming System, and therefore does not automatically command priming boluses. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Hemoglobin A1c | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
|
| Participants |
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| Secondary | Difference in Overall Percent Time-in-range | Percentage of CGM values falling between 70 and 180 mg/dL | Posted | Mean | Standard Deviation | percentage of CGM values | 24 hours |
|
|
|
| Secondary | Difference in Daytime Percent Time-below-range | Percentage of CGM values falling below 70mg/dL during daytime (6am to midnight) | Posted | Median | Inter-Quartile Range | percentage of CGM values | 18 hours |
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|
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| Secondary | Difference in Overall Percent Time-below-range | Percentage of CGM values falling below 70mg/dL | Posted | Median | Inter-Quartile Range | percentage of CGM values | 24 hours |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Full Closed-loop (FCL) Without Bolus Priming System (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:
FCL+BPS: 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 FCL: The automated insulin delivery system does not include the Bolus Priming System, and therefore does not automatically command priming boluses. | 0 | 11 | 0 | 11 | 1 | 11 |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |