Trial Outcomes & Findings for Neural-net Artificial Pancreas (NAP) (NCT NCT05876273)
NCT ID: NCT05876273
Last Updated: 2024-07-31
Results Overview
The primary outcome is percent of time in 70 to 180 mg/dL range on NAP vs UMPC.
COMPLETED
NA
15 participants
36 hours (two 18-hour experiments)
2024-07-31
Participant Flow
This study is intended to assess a Neural-net Artificial Pancreas (NAP) implementation of an established AP controller - the University of Virginia Model Predictive Control Algorithm (UMPC). The health outcomes achieved on NAP will be compared to the health outcomes achieved on UMPC in a randomized crossover design. The investigators will consent up to 20 participants, ages ≥18.0, with a goal of completing 15 participants.
Participant milestones
| Measure |
NAP First, Then UMPC
Participants will use the Neural Net Artificial Pancreas (NAP) algorithm for 18 hours. Then switch to the University of Virginia Model-Predictive Control (UMPC) for 18 hours.
|
UMPC First, Then NAP
Participants will use the UMPC for 18 hours, then switch to NAP for 18 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neural-net Artificial Pancreas (NAP)
Baseline characteristics by cohort
| Measure |
All Participants
n=15 Participants
Participants completed two consecutive 20-hour hotel sessions, receiving in random order either NAP or UMPC
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
47.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
|
Percent Time in Range (70-180 mg/dL)
|
69.3 Percent of time between 70-180 mg/dl
STANDARD_DEVIATION 13.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 36 hours (two 18-hour experiments)The primary outcome is percent of time in 70 to 180 mg/dL range on NAP vs UMPC.
Outcome measures
| Measure |
Overall Study
n=15 Participants
All subjects randomized
|
|---|---|
|
Percent of Time-in-Range (TIR) on NAP Versus UMPC.
Time in Range (NAP)
|
86.08 Percent of time between 70-180 mg/dl
Standard Deviation 6.5
|
|
Percent of Time-in-Range (TIR) on NAP Versus UMPC.
Time in Range (UMPC)
|
87.25 Percent of time between 70-180 mg/dl
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: 36 hours (two 18-hour experiments)Percent CGM readings above 180 mg/dL.
Outcome measures
| Measure |
Overall Study
n=15 Participants
All subjects randomized
|
|---|---|
|
Percent of Time in Hyperglycemia.
Percent CGM readings above 180 mg/dL (NAP)
|
11.93 Percent of time above 180 mg/dl
Standard Deviation 6.4
|
|
Percent of Time in Hyperglycemia.
Percent CGM readings above 180 mg/dL (UMPC)
|
10.96 Percent of time above 180 mg/dl
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: 36 hours (two 18-hour experiments)Percent CGM readings below 70 mg/dL.
Outcome measures
| Measure |
Overall Study
n=15 Participants
All subjects randomized
|
|---|---|
|
Percent of Time in Hypoglycemia.
Percent CGM readings below 70 mg/dL (NAP)
|
1.88 Percent of time below 70 mg/dl
Standard Deviation 2.25
|
|
Percent of Time in Hypoglycemia.
Percent CGM readings below 70 mg/dL (UMPC)
|
1.79 Percent of time below 70 mg/dl
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 36 hours (two 18-hour experiments)The investigator will observe, record, and tabulate any system malfunctions requiring study team intervention.
Outcome measures
| Measure |
Overall Study
n=15 Participants
All subjects randomized
|
|---|---|
|
System Functionality
|
0 Number of reportable device malfunctions
|
SECONDARY outcome
Timeframe: 36 hours (two 18-hour experiments)Population: Data were not collected
The investigator will obtain qualitative feedback form the participants regarding system functionality.
Outcome measures
Outcome data not reported
Adverse Events
NAP First, Then UMPC
UMPC First, Then NAP
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boris Kovatchev, PhD
Center for Diabetes Technology, University of Virginia School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place