Trial Outcomes & Findings for Exercise-Induced Hypoglycemia Prevention in Adults With Type 1 Diabetes Using an Artificial Pancreas (NCT NCT03859401)
NCT ID: NCT03859401
Last Updated: 2026-05-05
Results Overview
Number of hypoglycemic occurrences immediately before, during, and immediately after exercise (\~5-7pm) as defined by more than one consecutive CGM values below 70 mg/dL or hypoglycemic treatment per glycemic guidelines.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
2 Hours
Results posted on
2026-05-05
Participant Flow
Participant milestones
| Measure |
Experimental: Control - Experimental Admissions
Subjects will be randomized following the Data Collection Phase in a 1:1 ratio. Subjects in the Control-Experimental Arm will undergo the Control Admission first, utilizing an artificial pancreas (AP) controller that does not anticipate exercise (rMPC - naïve model predictive control), followed by the Experimental Admission, which will utilize an AP controller that has the ability to anticipate exercise (EnMPC - ensemble model predictive control). During the 36-hour admissions, subjects will begin using the study AP system (control or experimental) on Day 1 around midday with a scheduled exercise activity in the evening. Day 2 will consist of minimal activity and subjects will be discharged in the evening on Day 2.
|
Experimental: Experimental - Control Admissions
Subjects will be randomized following the Data Collection Phase in a 1:1 ratio. Subjects in the Experimental-Control Arm will undergo the Experimental Admission first, utilizing an artificial pancreas (AP) controller that has the ability to anticipate exercise (EnMPC), followed by the Control Admission, which will utilize an AP controller that does not have the ability to anticipate exercise (rMPC). During the 36-hour admissions, subjects will begin using the study AP system (control or experimental) on Day 1 around midday with a scheduled exercise activity in the evening. Day 2 will consist of minimal activity and subjects will be discharged in the evening on Day 2.
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|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise-Induced Hypoglycemia Prevention in Adults With Type 1 Diabetes Using an Artificial Pancreas
Baseline characteristics by cohort
| Measure |
Experimental: Control - Experimental Admissions
n=7 Participants
Subjects will be randomized following the Data Collection Phase in a 1:1 ratio. Subjects in the Control-Experimental Arm will undergo the Control Admission first, utilizing an artificial pancreas (AP) controller that does not anticipate exercise (rMPC - naïve model predictive control), followed by the Experimental Admission, which will utilize an AP controller that has the ability to anticipate exercise (EnMPC - ensemble model predictive control). During the 36-hour admissions, subjects will begin using the study AP system (control or experimental) on Day 1 around midday with a scheduled exercise activity in the evening. Day 2 will consist of minimal activity and subjects will be discharged in the evening on Day 2.
|
Experimental: Experimental - Control Admissions
n=8 Participants
Subjects will be randomized following the Data Collection Phase in a 1:1 ratio. Subjects in the Experimental-Control Arm will undergo the Experimental Admission first, utilizing an artificial pancreas (AP) controller that has the ability to anticipate exercise (EnMPC), followed by the Control Admission, which will utilize an AP controller that does not have the ability to anticipate exercise (rMPC). During the 36-hour admissions, subjects will begin using the study AP system (control or experimental) on Day 1 around midday with a scheduled exercise activity in the evening. Day 2 will consist of minimal activity and subjects will be discharged in the evening on Day 2.
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Total
n=15 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
42.9 years
STANDARD_DEVIATION 10.9 • n=54 Participants
|
41.6 years
STANDARD_DEVIATION 16.3 • n=60 Participants
|
42.2 years
STANDARD_DEVIATION 13.5 • n=114 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
10 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
5 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=54 Participants
|
8 Participants
n=60 Participants
|
15 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Weight
|
86.9 kg
STANDARD_DEVIATION 11.5 • n=54 Participants
|
78.7 kg
STANDARD_DEVIATION 16.7 • n=60 Participants
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82.5 kg
STANDARD_DEVIATION 14.6 • n=114 Participants
|
|
Height
|
164.1 cm
STANDARD_DEVIATION 11.3 • n=54 Participants
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173.2 cm
STANDARD_DEVIATION 10.2 • n=60 Participants
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168.9 cm
STANDARD_DEVIATION 11.3 • n=114 Participants
|
|
HbA1c
|
6.7 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.3 • n=54 Participants
|
6.6 percentage of glycated hemoglobin
STANDARD_DEVIATION 1.1 • n=60 Participants
|
6.6 percentage of glycated hemoglobin
STANDARD_DEVIATION 1.0 • n=114 Participants
|
|
Type 1 Diabetes Duration
|
30.6 years
STANDARD_DEVIATION 13.3 • n=54 Participants
|
21.9 years
STANDARD_DEVIATION 14.2 • n=60 Participants
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26.8 years
STANDARD_DEVIATION 13.6 • n=114 Participants
|
PRIMARY outcome
Timeframe: 2 HoursNumber of hypoglycemic occurrences immediately before, during, and immediately after exercise (\~5-7pm) as defined by more than one consecutive CGM values below 70 mg/dL or hypoglycemic treatment per glycemic guidelines.
Outcome measures
| Measure |
APEX (Experimental)
n=15 Participants
Multi-stage Model Predictive Control (MS-MPC/APEX) exercise-aware, controller (experimental condition)
|
HCL (Control)
n=15 Participants
state-of-the-art, Regular Model Predictive Control Hybrid (HCL) (control condition)
|
|---|---|---|
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Number of Hypoglycemic Occurrences in Relation to Exercise Activity
|
0 occurence
Interval 0.0 to 1.0
|
1 occurence
Interval 0.0 to 1.7
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SECONDARY outcome
Timeframe: 36 HoursAverage CGM value
Outcome measures
| Measure |
APEX (Experimental)
n=15 Participants
Multi-stage Model Predictive Control (MS-MPC/APEX) exercise-aware, controller (experimental condition)
|
HCL (Control)
n=15 Participants
state-of-the-art, Regular Model Predictive Control Hybrid (HCL) (control condition)
|
|---|---|---|
|
Average CGM
|
141.9 mg/dl
Standard Deviation 20.3
|
136.9 mg/dl
Standard Deviation 19.9
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SECONDARY outcome
Timeframe: 36 HoursPercentage of time CGM was below 54 mg/dL
Outcome measures
| Measure |
APEX (Experimental)
n=15 Participants
Multi-stage Model Predictive Control (MS-MPC/APEX) exercise-aware, controller (experimental condition)
|
HCL (Control)
n=15 Participants
state-of-the-art, Regular Model Predictive Control Hybrid (HCL) (control condition)
|
|---|---|---|
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Percent Time CGM Below 54 mg/dL
|
0 percentage of time
Interval 0.0 to 0.0
|
0 percentage of time
Interval 0.0 to 0.3
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SECONDARY outcome
Timeframe: 36 HoursPercentage of time CGM was below 70 mg/dL
Outcome measures
| Measure |
APEX (Experimental)
n=15 Participants
Multi-stage Model Predictive Control (MS-MPC/APEX) exercise-aware, controller (experimental condition)
|
HCL (Control)
n=15 Participants
state-of-the-art, Regular Model Predictive Control Hybrid (HCL) (control condition)
|
|---|---|---|
|
Percent Time CGM Below 70 mg/dL
|
0 percentage of time
Interval 0.0 to 0.7
|
1.3 percentage of time
Interval 0.0 to 2.7
|
SECONDARY outcome
Timeframe: 36 HoursPercentage of time CGM was between 70 and 180 mg/dL
Outcome measures
| Measure |
APEX (Experimental)
n=15 Participants
Multi-stage Model Predictive Control (MS-MPC/APEX) exercise-aware, controller (experimental condition)
|
HCL (Control)
n=15 Participants
state-of-the-art, Regular Model Predictive Control Hybrid (HCL) (control condition)
|
|---|---|---|
|
Percent Time CGM Between 70 and 180 mg/dL
|
81 percentage of time
Standard Deviation 15.7
|
81 percentage of time
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: 36 HoursPercentage of time CGM was between 70 and 140 mg/dL
Outcome measures
| Measure |
APEX (Experimental)
n=15 Participants
Multi-stage Model Predictive Control (MS-MPC/APEX) exercise-aware, controller (experimental condition)
|
HCL (Control)
n=15 Participants
state-of-the-art, Regular Model Predictive Control Hybrid (HCL) (control condition)
|
|---|---|---|
|
Percent Time CGM Between 70 and 140 mg/dL
|
58.4 percentage of time
Standard Deviation 15.3
|
62 percentage of time
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: 36 HoursPercentage of time CGM was above 180 mg/dL
Outcome measures
| Measure |
APEX (Experimental)
n=15 Participants
Multi-stage Model Predictive Control (MS-MPC/APEX) exercise-aware, controller (experimental condition)
|
HCL (Control)
n=15 Participants
state-of-the-art, Regular Model Predictive Control Hybrid (HCL) (control condition)
|
|---|---|---|
|
Percent Time CGM Above 180 mg/dL
|
18.5 percentage of time
Standard Deviation 15.9
|
16.6 percentage of time
Standard Deviation 112.6
|
SECONDARY outcome
Timeframe: 36 HoursPercentage of time CGM was above 250 mg/dL
Outcome measures
| Measure |
APEX (Experimental)
n=15 Participants
Multi-stage Model Predictive Control (MS-MPC/APEX) exercise-aware, controller (experimental condition)
|
HCL (Control)
n=15 Participants
state-of-the-art, Regular Model Predictive Control Hybrid (HCL) (control condition)
|
|---|---|---|
|
Percent Time CGM Above 250 mg/dL
|
0 percentage of time
Interval 0.0 to 4.4
|
0 percentage of time
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 36 HoursCoefficient of Variation of the CGM Values
Outcome measures
| Measure |
APEX (Experimental)
n=15 Participants
Multi-stage Model Predictive Control (MS-MPC/APEX) exercise-aware, controller (experimental condition)
|
HCL (Control)
n=15 Participants
state-of-the-art, Regular Model Predictive Control Hybrid (HCL) (control condition)
|
|---|---|---|
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CGM Coefficient of Variation
|
29.1 percentage of coefficient of variation
Standard Deviation 6.3
|
30.5 percentage of coefficient of variation
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: 36 HoursCGM-based Low Blood Glucose Index (LBGI) which is a metric used to quantify the risk of hypoglycemia (low blood sugar) based on self-monitored blood glucose (SMBG) data. LBGI is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values \<1 suggest low risk of hypoglycemia.
Outcome measures
| Measure |
APEX (Experimental)
n=15 Participants
Multi-stage Model Predictive Control (MS-MPC/APEX) exercise-aware, controller (experimental condition)
|
HCL (Control)
n=15 Participants
state-of-the-art, Regular Model Predictive Control Hybrid (HCL) (control condition)
|
|---|---|---|
|
CGM-based Low Blood Glucose Index
|
0.3 Index
Interval 0.3 to 0.7
|
0.6 Index
Interval 0.4 to 0.9
|
SECONDARY outcome
Timeframe: 36 HoursStandard Deviation of the CGM Values
Outcome measures
| Measure |
APEX (Experimental)
n=15 Participants
Multi-stage Model Predictive Control (MS-MPC/APEX) exercise-aware, controller (experimental condition)
|
HCL (Control)
n=15 Participants
state-of-the-art, Regular Model Predictive Control Hybrid (HCL) (control condition)
|
|---|---|---|
|
CGM Standard Deviation
|
42 mg/dl
Standard Deviation 12.2
|
42 mg/dl
Standard Deviation 11.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 HoursTotal Amount of Insulin Used, units
Outcome measures
| Measure |
APEX (Experimental)
n=15 Participants
Multi-stage Model Predictive Control (MS-MPC/APEX) exercise-aware, controller (experimental condition)
|
HCL (Control)
n=15 Participants
state-of-the-art, Regular Model Predictive Control Hybrid (HCL) (control condition)
|
|---|---|---|
|
Total Amount of Insulin Used
|
46.2 unit
Standard Deviation 13
|
50.6 unit
Standard Deviation 18.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 HoursNumber of Hypoglycemic Episodes as defined by contiguous CGM below 70 mg/dL
Outcome measures
| Measure |
APEX (Experimental)
n=15 Participants
Multi-stage Model Predictive Control (MS-MPC/APEX) exercise-aware, controller (experimental condition)
|
HCL (Control)
n=15 Participants
state-of-the-art, Regular Model Predictive Control Hybrid (HCL) (control condition)
|
|---|---|---|
|
Number of Hypoglycemic Episodes
|
0 Episodes
Interval 0.0 to 1.0
|
1 Episodes
Interval 1.0 to 3.0
|
Adverse Events
HCL (Control)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
APEX (Experimental)
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 |
HCL (Control)
n=15 participants at risk
Subjects will be randomized following the Data Collection Phase in a 1:1 ratio. Subjects in the Control-Experimental Arm will undergo the Control Admission first, utilizing an artificial pancreas (AP) controller that does not anticipate exercise (rMPC - naïve model predictive control), followed by the Experimental Admission, which will utilize an AP controller that has the ability to anticipate exercise (EnMPC - ensemble model predictive control). During the 36-hour admissions, subjects will begin using the study AP system (control or experimental) on Day 1 around midday with a scheduled exercise activity in the evening. Day 2 will consist of minimal activity and subjects will be discharged in the evening on Day 2.
|
APEX (Experimental)
n=15 participants at risk
Subjects will be randomized following the Data Collection Phase in a 1:1 ratio. Subjects in the Experimental-Control Arm will undergo the Experimental Admission first, utilizing an artificial pancreas (AP) controller that has the ability to anticipate exercise (EnMPC), followed by the Control Admission, which will utilize an AP controller that does not have the ability to anticipate exercise (rMPC). During the 36-hour admissions, subjects will begin using the study AP system (control or experimental) on Day 1 around midday with a scheduled exercise activity in the evening. Day 2 will consist of minimal activity and subjects will be discharged in the evening on Day 2.
|
|---|---|---|
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Skin and subcutaneous tissue disorders
Skin infection on arm
|
6.7%
1/15 • Enrollment to second admission day, ~ 2 months
|
0.00%
0/15 • Enrollment to second admission day, ~ 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place