Trial Outcomes & Findings for Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm (NCT NCT06728059)
NCT ID: NCT06728059
Last Updated: 2026-05-28
Results Overview
CGM-measured time in range (TIR, 70-180 mg/dL) during the 18-hour hotel sessions on AIDANET or AIDANET+BPS\_RL. The time periods begin at 6 PM and end at noon on the next day, thereby covering two meals - dinner and breakfast.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
36 hours total (18 hours for Group A and 18 hours for Group B)
Results posted on
2026-05-28
Participant Flow
Three participants were determined to be ineligible. One withdrew before randomization.
Participant milestones
| Measure |
AIDANET→AIDANET+ BPS_RL
Group A: AIDANET (Automated Insulin Delivery Adaptive NETwork) followed by AIDANET+ BPS\_RL during the hotel session
Group A participants will use the AIDANET system at home for 7 days/6 nights. During the hotel session, they will continue to use the AIDANET system for 18 hours, followed by 18 hours of use of AIDANET+BPS\_RL.
They will continue to use AIDANET+ BPS\_RL system at home for 7 days/6 nights.
|
AIDANET+ BPS_RL→AIDANET
Group B: AIDANET+BPS\_RL followed by AIDANET during the hotel session
Group B participants will use the AIDANET system at home for 7 days/6 nights. Then, during the hotel session, they will use the AIDANET+BPS\_RL system for 18 hours, followed by 18 hours with the AIDANET system.
They will then continue to use AIDANET+BPS\_RL system at home for 7 days/6 nights.
|
|---|---|---|
|
Overall
STARTED
|
8
|
7
|
|
Overall
COMPLETED
|
8
|
7
|
|
Overall
NOT COMPLETED
|
0
|
0
|
|
AIDANET training and 1-week at-home use
STARTED
|
8
|
7
|
|
AIDANET training and 1-week at-home use
COMPLETED
|
8
|
7
|
|
AIDANET training and 1-week at-home use
NOT COMPLETED
|
0
|
0
|
|
Hotel admission intervention
STARTED
|
8
|
7
|
|
Hotel admission intervention
COMPLETED
|
8
|
7
|
|
Hotel admission intervention
NOT COMPLETED
|
0
|
0
|
|
AIDANET+BPS-RL 1-week at-home use
STARTED
|
8
|
7
|
|
AIDANET+BPS-RL 1-week at-home use
COMPLETED
|
8
|
7
|
|
AIDANET+BPS-RL 1-week at-home use
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm
Baseline characteristics by cohort
| Measure |
AIDANET→AIDANET+ BPS_RL
n=8 Participants
Group A: AIDANET followed by AIDANET+ BPS\_RL during the hotel session
Automated Insulin Delivery Adaptive NETwork (AIDANET): Group A participants will use the AIDANET system at home for 7 days/6 nights. They will continue use of AIDANET system for 18 hours during the hotel session and then use AIDANET+BPS\_RL for 18 hours during the hotel session.
|
AIDANET+ BPS_RL→AIDANET
n=7 Participants
Group B: AIDANET+BPS\_RL followed by AIDANET during the hotel session
AIDANET+ BPS\_RL→AIDANET: Group B participant will use the AIDANET+BPS\_RL system for 18 hours during the hotel session and will then use AIDANET system for 18 hours during the hotel session. They will continue to use AIDANET+BPS\_RL system at home for 7 days/6 night and then use the AIDANET system at home for 7 days/6 nights.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
14 Participants
n=65 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
|
Age, Continuous
|
42.8 Years
STANDARD_DEVIATION 11.1 • n=51 Participants
|
45.7 Years
STANDARD_DEVIATION 13.2 • n=14 Participants
|
44.1 Years
STANDARD_DEVIATION 11.8 • n=65 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=51 Participants
|
5 Participants
n=14 Participants
|
9 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=51 Participants
|
2 Participants
n=14 Participants
|
6 Participants
n=65 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=51 Participants
|
7 Participants
n=14 Participants
|
14 Participants
n=65 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
14 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=51 Participants
|
7 Participants
n=14 Participants
|
15 Participants
n=65 Participants
|
PRIMARY outcome
Timeframe: 36 hours total (18 hours for Group A and 18 hours for Group B)Population: 12 instead of 15 are included here because 3 participants had a software error that did not allow evaluation in this part of the study, primarily due to changes in meals
CGM-measured time in range (TIR, 70-180 mg/dL) during the 18-hour hotel sessions on AIDANET or AIDANET+BPS\_RL. The time periods begin at 6 PM and end at noon on the next day, thereby covering two meals - dinner and breakfast.
Outcome measures
| Measure |
AIDANET With BPRL
n=12 Participants
Intervention arm: Aidanet with BPRL
|
AIDANET
n=12 Participants
Intervention arm: AIDANET
|
|---|---|---|
|
CGM-measured Time in Range (TIR, 70-180 mg/dL) During the 18-hour Hotel Sessions.
|
85.7 percentage of time
Standard Deviation 8.7
|
86.5 percentage of time
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 18 hoursPopulation: 12 instead of 15 are included here because 3 participants had a software error that did not allow evaluation in this part of the study, primarily due to changes in meals.
CGM-measured Time below range \<70mg/dL during the 18-hour hotel session on AIDANET or AIDANET+BPS\_RL
Outcome measures
| Measure |
AIDANET With BPRL
n=12 Participants
Intervention arm: Aidanet with BPRL
|
AIDANET
n=12 Participants
Intervention arm: AIDANET
|
|---|---|---|
|
CGM-measured Time Below Range <70mg/dL During Hotel Session
|
0 percentage of time
Interval 0.0 to 1.4
|
0 percentage of time
Interval 0.0 to 1.9
|
SECONDARY outcome
Timeframe: 7 daysCGM-measured Time in range (70-180 mg/dL) for at-home sessions using AIDANET
Outcome measures
| Measure |
AIDANET With BPRL
n=15 Participants
Intervention arm: Aidanet with BPRL
|
AIDANET
n=15 Participants
Intervention arm: AIDANET
|
|---|---|---|
|
CGM-measured Time in Range (70-180 mg/dL) for At-home
|
71.7 percentage of time
Standard Deviation 9.0
|
77.0 percentage of time
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: 1 weekCGM-measured Time below range 70 mg/dL for at-home sessions using AIDANET or AIDANET BPS-RL
Outcome measures
| Measure |
AIDANET With BPRL
n=15 Participants
Intervention arm: Aidanet with BPRL
|
AIDANET
n=15 Participants
Intervention arm: AIDANET
|
|---|---|---|
|
CGM-measured Time Below Range 70 mg/dL for At-home
|
2.3 percentage of time
Standard Deviation 1.3
|
2.2 percentage of time
Standard Deviation 1.5
|
Adverse Events
AIDANET
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AIDANET BPS_RL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place