Trial Outcomes & Findings for Context Aware Data Gathering Study (NCT NCT04154904)

Last Updated: 2023-08-01

Results Overview

We used our recently published long short term memory neural network (LSTM) to predict sensor glucose 30-minutes in advance across the entire 4-week study duration when glucose was \< 70 mg/dL. We then used the context-aware pattern recognition algorithm to predict when hypoglycemia would occur 30-minutes in the future, and if hypoglycemia was predicted, we included a bias correction that is specific to the hypogylcemia region of glucose measurements. The outcome measure shows the reduction of MARD when the LSTM is corrected using the pattern-based bias correction algorithm. MARD is calculated by subtracting the new sensor glucose - reference value dividing by the reference value. A negative value means that the MARD was reduced. The LSTM is being compared with Dexcom G6 CGM values to determine the MARD. Physiologically relevant thresholds are less than 55 mg/dl, less than 70 mg/dl, above 180 mg/dl and above 250 mg/dl. The Dexcom G6 target range is 70-180 mg/dl.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

28 days

Results posted on

2023-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	Aerobic Exercise Exercise: Subjects will be randomized to complete either aerobic, high intensity interval training, or resistance exercise videos twice weekly at home.	Resistance Exercise Exercise: Subjects will be randomized to complete either aerobic, high intensity interval training, or resistance exercise videos twice weekly at home.	High Intensity Interval Exercise Exercise: Subjects will be randomized to complete either aerobic, high intensity interval training, or resistance exercise videos twice weekly at home.
Study Start-up Visit STARTED	10	10	10
Study Start-up Visit COMPLETED	10	10	10
Study Start-up Visit NOT COMPLETED	0	0	0
At Home Period (28 Days) STARTED	10	10	10
At Home Period (28 Days) COMPLETED	10	10	9
At Home Period (28 Days) NOT COMPLETED	0	0	1
Study Close-out Visit STARTED	10	10	9
Study Close-out Visit COMPLETED	10	10	9
Study Close-out Visit NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Aerobic Exercise Exercise: Subjects will be randomized to complete either aerobic, high intensity interval training, or resistance exercise videos twice weekly at home.	Resistance Exercise Exercise: Subjects will be randomized to complete either aerobic, high intensity interval training, or resistance exercise videos twice weekly at home.	High Intensity Interval Exercise Exercise: Subjects will be randomized to complete either aerobic, high intensity interval training, or resistance exercise videos twice weekly at home.
At Home Period (28 Days) Withdrawal by Subject	0	0	1

Baseline Characteristics

Context Aware Data Gathering Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aerobic Exercise n=10 Participants Exercise: Subjects will be randomized to complete either aerobic, high intensity interval training, or resistance exercise videos twice weekly at home.	Resistance Exercise n=10 Participants Exercise: Subjects will be randomized to complete either aerobic, high intensity interval training, or resistance exercise videos twice weekly at home.	High Intensity Interval Exercise n=10 Participants Exercise: Subjects will be randomized to complete either aerobic, high intensity interval training, or resistance exercise videos twice weekly at home.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	37.1 years STANDARD_DEVIATION 12.9 • n=5 Participants	36.5 years STANDARD_DEVIATION 12.9 • n=7 Participants	34.7 years STANDARD_DEVIATION 12.3 • n=5 Participants	36.1 years STANDARD_DEVIATION 12.3 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	18 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	29 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	25 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	30 participants n=4 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Each arm had participants that completed the study but had incomplete insulin data which prevented inclusion in the analysis of outcome measures: 5 from aerobic arm, 4 from resistance arm, 3 from HIIT arm.

Outcome measures

Outcome measures
Measure	Aerobic Exercise n=5 Participants This analysis includes 5 study participants that were randomized to aerobic exercise for this study.	Resistance Exercise n=6 Participants This analysis includes 6 participants randomized to resistance exercise for this study.	High Intensity Interval (HIIT) Exercise n=6 Participants This analysis includes 6 participants randomized to HIIT exercise for the study.
Comparison of the Mean Absolute Relative Difference When Including Patterns in Hypoglycemia Prediction.	-0.5 percent difference of MARD Standard Deviation 7.6	-3.1 percent difference of MARD Standard Deviation 1.4	-2.8 percent difference of MARD Standard Deviation 2.4

PRIMARY outcome

Timeframe: 28 days

We used our recently published long short term memory neural network (LSTM) to predict glucose 30-minutes in advance across the entire 4-week study duration when glucose was \< 70 mg/dL. We then used the context-aware pattern recognition algorithm to predict when hypoglycemia would occur 30-minutes in the future, and if hypoglycemia was predicted, we included a bias correction that is specific to the hypogylcemia region of glucose measurements. The outcome measure shows the reduction of mean relative difference (MRD) when the LSTM is corrected using the pattern-based bias correction algorithm. MARD is calculated by subtracting the new sensor glucose - reference value dividing by the reference value. A negative value means that the MARD was reduced. The LSTM is being compared with Dexcom G6 CGM values to determine the MARD. Physiologically relevant thresholds are less than 55 mg/dl, less than 70 mg/dl, above 180 mg/dl and above 250 mg/dl. The Dexcom G6 target range is 70-180 mg/dl.

Outcome measures

Outcome measures
Measure	Aerobic Exercise n=5 Participants This analysis includes 5 study participants that were randomized to aerobic exercise for this study.	Resistance Exercise n=6 Participants This analysis includes 6 participants randomized to resistance exercise for this study.	High Intensity Interval (HIIT) Exercise n=6 Participants This analysis includes 6 participants randomized to HIIT exercise for the study.
Comparison of the Mean Relative Difference When Including Patterns in Hypoglycemia Prediction.	-8.1 percent difference of MRD Standard Deviation 5.1	-4.8 percent difference of MRD Standard Deviation 2.4	-4.0 percent difference of MRD Standard Deviation 3.2

Adverse Events

Aerobic Exercise

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Resistance Exercise

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

High Intensity Interval Exercise

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Aerobic Exercise n=10 participants at risk Exercise: Subjects will be randomized to complete either aerobic, high intensity interval training, or resistance exercise videos twice weekly at home.	Resistance Exercise n=10 participants at risk Exercise: Subjects will be randomized to complete either aerobic, high intensity interval training, or resistance exercise videos twice weekly at home.	High Intensity Interval Exercise n=10 participants at risk Exercise: Subjects will be randomized to complete either aerobic, high intensity interval training, or resistance exercise videos twice weekly at home.
Infections and infestations urinary tract infection	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
Infections and infestations upper respiratory infection	10.0% 1/10 • Number of events 1 • 28 days	10.0% 1/10 • Number of events 1 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
Skin and subcutaneous tissue disorders rash at sensor site	10.0% 1/10 • Number of events 1 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days
Musculoskeletal and connective tissue disorders Knee pain	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
Skin and subcutaneous tissue disorders rash from antibiotics	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
Skin and subcutaneous tissue disorders Hives	10.0% 1/10 • Number of events 1 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days

Additional Information

Jessica Castle

Oregon Health and Science University

Phone: 1503-494-7072

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place