Trial Outcomes & Findings for Extended Bolus for Meals in a Closed-loop System (NCT NCT05454891)
NCT ID: NCT05454891
Last Updated: 2026-05-12
Results Overview
Area under the curve between glucose trace and starting glucose (mg/dL\* min)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
0 to 5 hours post-meal onset
Results posted on
2026-05-12
Participant Flow
A total of 30 participants were enrolled. Three participants were screen failures. Of the remaining 27 eligible participants, 22 were randomized and 5 withdrew or were withdrawn prior to randomization.
Participant milestones
| Measure |
High Fat High Protein (HFHP) Meal With Standard Insulin Bolus Then Extended Bolus
Subjects will receive standard meal bolus for the HFHP breakfast first. On a separate morning, subjects will receive an extended meal bolus for the HFHP breakfast.
|
High Fat High Protein (HFHP) Meal With Extended Insulin Bolus Then Standard Bolus
Subjects will receive extended meal bolus for the HFHP breakfast first. On a separate morning, subjects will receive a standard meal bolus for the HFHP breakfast.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
8
|
|
Overall Study
COMPLETED
|
11
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
High Fat High Protein (HFHP) Meal With Standard Insulin Bolus Then Extended Bolus
Subjects will receive standard meal bolus for the HFHP breakfast first. On a separate morning, subjects will receive an extended meal bolus for the HFHP breakfast.
|
High Fat High Protein (HFHP) Meal With Extended Insulin Bolus Then Standard Bolus
Subjects will receive extended meal bolus for the HFHP breakfast first. On a separate morning, subjects will receive a standard meal bolus for the HFHP breakfast.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Extended Bolus for Meals in a Closed-loop System
Baseline characteristics by cohort
| Measure |
High Fat High Protein (HFHP) Meal With Standard Insulin Bolus Then Extended Bolus
n=11 Participants
Subjects will receive standard meal bolus for the HFHP breakfast first. On a separate morning, subjects will receive an extended meal bolus for the HFHP breakfast.
|
High Fat High Protein (HFHP) Meal With Extended Insulin Bolus Then Standard Bolus
n=7 Participants
Subjects will receive extended meal bolus for the HFHP breakfast first. On a separate morning, subjects will receive a standard meal bolus for the HFHP breakfast.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=1512 Participants
|
7 Participants
n=504 Participants
|
18 Participants
n=2016 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=1512 Participants
|
4 Participants
n=504 Participants
|
10 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
8 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=1512 Participants
|
4 Participants
n=504 Participants
|
12 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
4 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
PRIMARY outcome
Timeframe: 0 to 5 hours post-meal onsetArea under the curve between glucose trace and starting glucose (mg/dL\* min)
Outcome measures
| Measure |
High Fat High Protein (HFHP) Meal With Extended Insulin Bolus
n=18 Participants
Subjects will receive extended meal bolus for the HFHP breakfast.
|
High Fat High Protein (HFHP) Meal With Standard Insulin Bolus
n=18 Participants
Subjects will receive standard meal bolus for the HFHP breakfast.
|
|---|---|---|
|
Glucose Area Under Curve [AUC]
|
48641.5 (mg/dL* min)
Standard Deviation 11789.8
|
45371.8 (mg/dL* min)
Standard Deviation 6737.0
|
SECONDARY outcome
Timeframe: 0 to 5 hours post-meal onsetPercentage of time spent between 70-180 mg/dl based on Continuous Glucose Monitor (CGM) values
Outcome measures
| Measure |
High Fat High Protein (HFHP) Meal With Extended Insulin Bolus
n=18 Participants
Subjects will receive extended meal bolus for the HFHP breakfast.
|
High Fat High Protein (HFHP) Meal With Standard Insulin Bolus
n=18 Participants
Subjects will receive standard meal bolus for the HFHP breakfast.
|
|---|---|---|
|
Percentage of Time Between 70-180 mg/dL
|
71.3 Percentage of time
Standard Deviation 33.2
|
73.6 Percentage of time
Standard Deviation 22.5
|
SECONDARY outcome
Timeframe: 0 to 5 hours post-meal onsetPercentage of time spent with blood sugar less than 70 mg/dL based on Continuous Glucose Monitor (CGM) values
Outcome measures
| Measure |
High Fat High Protein (HFHP) Meal With Extended Insulin Bolus
n=18 Participants
Subjects will receive extended meal bolus for the HFHP breakfast.
|
High Fat High Protein (HFHP) Meal With Standard Insulin Bolus
n=18 Participants
Subjects will receive standard meal bolus for the HFHP breakfast.
|
|---|---|---|
|
Percentage of Time in Hypoglycemic Range (Defined as < 70 mg/dL)
|
0.0 Percentage of time
Standard Deviation 0.0
|
0.0 Percentage of time
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: 0 to 5 hours post-meal onsetAverage glucose value based on Continuous Glucose Monitor (CGM) values
Outcome measures
| Measure |
High Fat High Protein (HFHP) Meal With Extended Insulin Bolus
n=18 Participants
Subjects will receive extended meal bolus for the HFHP breakfast.
|
High Fat High Protein (HFHP) Meal With Standard Insulin Bolus
n=18 Participants
Subjects will receive standard meal bolus for the HFHP breakfast.
|
|---|---|---|
|
Average Glucose
|
161.7 mg/dL
Standard Deviation 38.9
|
151.1 mg/dL
Standard Deviation 22.4
|
SECONDARY outcome
Timeframe: 0 to 5 hours post-meal onsetPercentage of time spent with blood sugar higher than 180 mg/dL based on Continuous Glucose Monitor (CGM) values
Outcome measures
| Measure |
High Fat High Protein (HFHP) Meal With Extended Insulin Bolus
n=18 Participants
Subjects will receive extended meal bolus for the HFHP breakfast.
|
High Fat High Protein (HFHP) Meal With Standard Insulin Bolus
n=18 Participants
Subjects will receive standard meal bolus for the HFHP breakfast.
|
|---|---|---|
|
Percentage of Time in Hyperglycemic Range (Defined as ≥180 mg/dL);
|
28.7 Percentage of time
Standard Deviation 33.2
|
26.0 Percentage of time
Standard Deviation 22.5
|
SECONDARY outcome
Timeframe: 0 to 5 hours post-meal onsetTotal insulin received during 5 hrs ( manual bolus as well as automated)
Outcome measures
| Measure |
High Fat High Protein (HFHP) Meal With Extended Insulin Bolus
n=18 Participants
Subjects will receive extended meal bolus for the HFHP breakfast.
|
High Fat High Protein (HFHP) Meal With Standard Insulin Bolus
n=18 Participants
Subjects will receive standard meal bolus for the HFHP breakfast.
|
|---|---|---|
|
Insulin Dosage
|
15.4 Units
Standard Deviation 3.7
|
15.9 Units
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 0 to 5 hours post-meal onsetTime spent till blood glucose returns to 110mg/dL
Outcome measures
| Measure |
High Fat High Protein (HFHP) Meal With Extended Insulin Bolus
n=18 Participants
Subjects will receive extended meal bolus for the HFHP breakfast.
|
High Fat High Protein (HFHP) Meal With Standard Insulin Bolus
n=18 Participants
Subjects will receive standard meal bolus for the HFHP breakfast.
|
|---|---|---|
|
Time to Target (110mg/dL)
|
284.3 Minutes
Standard Deviation 47.4
|
294.2 Minutes
Standard Deviation 17.0
|
SECONDARY outcome
Timeframe: 0 to 5 hours post-meal onsetTime spent till blood glucose returns to baseline
Outcome measures
| Measure |
High Fat High Protein (HFHP) Meal With Extended Insulin Bolus
n=18 Participants
Subjects will receive extended meal bolus for the HFHP breakfast.
|
High Fat High Protein (HFHP) Meal With Standard Insulin Bolus
n=18 Participants
Subjects will receive standard meal bolus for the HFHP breakfast.
|
|---|---|---|
|
Time to Baseline
|
285.2 Minutes
Standard Deviation 44.2
|
294.2 Minutes
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: 0 to 5 hours post-meal onsetTime spent till blood glucose reaches the maximum value after meal
Outcome measures
| Measure |
High Fat High Protein (HFHP) Meal With Extended Insulin Bolus
n=18 Participants
Subjects will receive extended meal bolus for the HFHP breakfast.
|
High Fat High Protein (HFHP) Meal With Standard Insulin Bolus
n=18 Participants
Subjects will receive standard meal bolus for the HFHP breakfast.
|
|---|---|---|
|
Time to Peak Glucose
|
160.3 Minutes
Standard Deviation 69.4
|
204.7 Minutes
Standard Deviation 70.4
|
SECONDARY outcome
Timeframe: 0 to 5 hours post-meal onsetThe difference between baseline to max glucose value
Outcome measures
| Measure |
High Fat High Protein (HFHP) Meal With Extended Insulin Bolus
n=18 Participants
Subjects will receive extended meal bolus for the HFHP breakfast.
|
High Fat High Protein (HFHP) Meal With Standard Insulin Bolus
n=18 Participants
Subjects will receive standard meal bolus for the HFHP breakfast.
|
|---|---|---|
|
Change in Glucose
|
72.3 mg/dL
Standard Deviation 41.2
|
80.1 mg/dL
Standard Deviation 37.8
|
SECONDARY outcome
Timeframe: 0 to 5 hours post-meal onsetMax blood glucose
Outcome measures
| Measure |
High Fat High Protein (HFHP) Meal With Extended Insulin Bolus
n=18 Participants
Subjects will receive extended meal bolus for the HFHP breakfast.
|
High Fat High Protein (HFHP) Meal With Standard Insulin Bolus
n=18 Participants
Subjects will receive standard meal bolus for the HFHP breakfast.
|
|---|---|---|
|
Peak Glucose Concentration
|
199.1 mg/dL
Standard Deviation 43.2
|
203.4 mg/dL
Standard Deviation 36.6
|
SECONDARY outcome
Timeframe: 0 to 5 hours post-meal onsetPercent of glucose readings from CGM system between 70-140 mg/dL per unit of time
Outcome measures
| Measure |
High Fat High Protein (HFHP) Meal With Extended Insulin Bolus
n=18 Participants
Subjects will receive extended meal bolus for the HFHP breakfast.
|
High Fat High Protein (HFHP) Meal With Standard Insulin Bolus
n=18 Participants
Subjects will receive standard meal bolus for the HFHP breakfast.
|
|---|---|---|
|
Percentage of Time Between 70-140 mg/dL
|
34.2 Percentage of time
Standard Deviation 30.0
|
41.5 Percentage of time
Standard Deviation 21.3
|
Adverse Events
High Fat High Protein (HFHP) Meal With Standard Insulin Bolus
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
High Fat High Protein (HFHP) Meal With Extended Insulin Bolus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Fat High Protein (HFHP) Meal With Standard Insulin Bolus
n=22 participants at risk
Subjects will receive standard meal bolus for the HFHP breakfast.
|
High Fat High Protein (HFHP) Meal With Extended Insulin Bolus
n=22 participants at risk
Subjects will receive extended meal bolus for the HFHP breakfast.
|
|---|---|---|
|
Gastrointestinal disorders
Emesis
|
4.5%
1/22 • Throughout the 5 hour monitoring period post-meal onset
|
0.00%
0/22 • Throughout the 5 hour monitoring period post-meal onset
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place