Trial Outcomes & Findings for Evaluation of The Postprandial Impact of Automated Priming Bolus for Full Closed Loop Insulin Delivery (NCT NCT05528770)
NCT ID: NCT05528770
Last Updated: 2025-09-08
Results Overview
Percentage of CGM values falling between 70 and 180 mg/dL during daytime (6am to midnight)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
18 hours
Results posted on
2025-09-08
Participant Flow
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.
Participant milestones
| Measure |
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:
* A session of high-intensity interval training
* A high-carbohydrate, high-fat meal
* Ingestion of a bolus of simple sugar
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.
|
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:
* A session of high-intensity interval training
* A high-carbohydrate, high-fat meal
* Ingestion of a bolus of simple sugar
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.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of The Postprandial Impact of Automated Priming Bolus for Full Closed Loop Insulin Delivery
Baseline characteristics by cohort
| Measure |
Full Closed-loop (FCL) With Bolus Priming System (BPS) Followed by FCL Without BPS
n=6 Participants
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
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.
|
Full Closed-loop (FCL) Without Bolus Priming System (BPS) Followed by FCL With BPS
n=5 Participants
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
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.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.8 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 14.9 • n=7 Participants
|
38.4 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Baseline Hemoglobin A1c
|
6.3 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.9 • n=5 Participants
|
7.2 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.3 • n=7 Participants
|
6.7 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 18 hoursPercentage of CGM values falling between 70 and 180 mg/dL during daytime (6am to midnight)
Outcome measures
| Measure |
FCL With BPS
n=11 Participants
Fully closed-loop insulin delivery with bolus priming system
|
FCL Without BPS
n=11 Participants
Fully closed-loop insulin delivery without BPS
|
|---|---|---|
|
Difference in Daytime Percent Time-in-range
|
67.4 percentage of CGM values
Standard Deviation 15.1
|
65.1 percentage of CGM values
Standard Deviation 18.5
|
SECONDARY outcome
Timeframe: 24 hoursPercentage of CGM values falling between 70 and 180 mg/dL
Outcome measures
| Measure |
FCL With BPS
n=11 Participants
Fully closed-loop insulin delivery with bolus priming system
|
FCL Without BPS
n=11 Participants
Fully closed-loop insulin delivery without BPS
|
|---|---|---|
|
Difference in Overall Percent Time-in-range
|
74.3 percentage of CGM values
Standard Deviation 13.6
|
73.1 percentage of CGM values
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: 18 hoursPercentage of CGM values falling below 70mg/dL during daytime (6am to midnight)
Outcome measures
| Measure |
FCL With BPS
n=11 Participants
Fully closed-loop insulin delivery with bolus priming system
|
FCL Without BPS
n=11 Participants
Fully closed-loop insulin delivery without BPS
|
|---|---|---|
|
Difference in Daytime Percent Time-below-range
|
0 percentage of CGM values
Interval 0.0 to 2.1
|
0 percentage of CGM values
Interval 0.0 to 1.3
|
SECONDARY outcome
Timeframe: 24 hoursPercentage of CGM values falling below 70mg/dL
Outcome measures
| Measure |
FCL With BPS
n=11 Participants
Fully closed-loop insulin delivery with bolus priming system
|
FCL Without BPS
n=11 Participants
Fully closed-loop insulin delivery without BPS
|
|---|---|---|
|
Difference in Overall Percent Time-below-range
|
0 percentage of CGM values
Interval 0.0 to 1.6
|
0 percentage of CGM values
Interval 0.0 to 1.0
|
Adverse Events
Full Closed-loop (FCL) With Bolus Priming System (BPS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Full Closed-loop (FCL) Without Bolus Priming System (BPS)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Full Closed-loop (FCL) With Bolus Priming System (BPS)
n=11 participants at risk
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
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.
|
Full Closed-loop (FCL) Without Bolus Priming System (BPS)
n=11 participants at risk
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
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.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • 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.
|
9.1%
1/11 • Number of events 2 • 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.
|
Additional Information
Manager of Clinical Research
Center for Diabetes Technology
Phone: 434-982-0602
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place