Trial Outcomes & Findings for Evaluation of Physician-based Decision Support (NCT NCT03443713)
NCT ID: NCT03443713
Last Updated: 2020-03-18
Results Overview
Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using values uploaded to Dexcom Clarity. The percent of time with sensed glucose 70-180 mg/dl was averaged across days 1-7.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Days 1-7
Results posted on
2020-03-18
Participant Flow
Participant milestones
| Measure |
Aerobic Exercise
Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.
Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study.
|
Anaerobic Exercise
Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.
Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study.
|
High Intensity Interval Exercise
Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.
Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study.
|
|---|---|---|---|
|
Start up Visit (2 Hours)
STARTED
|
8
|
8
|
9
|
|
Start up Visit (2 Hours)
COMPLETED
|
8
|
8
|
9
|
|
Start up Visit (2 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
|
First at Home Period (9-14 Days)
STARTED
|
8
|
8
|
9
|
|
First at Home Period (9-14 Days)
COMPLETED
|
8
|
8
|
8
|
|
First at Home Period (9-14 Days)
NOT COMPLETED
|
0
|
0
|
1
|
|
First Exercise Visit (1 Hour)
STARTED
|
8
|
8
|
8
|
|
First Exercise Visit (1 Hour)
COMPLETED
|
8
|
8
|
8
|
|
First Exercise Visit (1 Hour)
NOT COMPLETED
|
0
|
0
|
0
|
|
Dexcom Insertion Visit (30 Minutes)
STARTED
|
8
|
8
|
8
|
|
Dexcom Insertion Visit (30 Minutes)
COMPLETED
|
8
|
8
|
8
|
|
Dexcom Insertion Visit (30 Minutes)
NOT COMPLETED
|
0
|
0
|
0
|
|
Second at Home Period (2-11 Days)
STARTED
|
8
|
8
|
8
|
|
Second at Home Period (2-11 Days)
COMPLETED
|
8
|
8
|
8
|
|
Second at Home Period (2-11 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Exercise Visit (1 Hour)
STARTED
|
8
|
8
|
8
|
|
Second Exercise Visit (1 Hour)
COMPLETED
|
8
|
8
|
8
|
|
Second Exercise Visit (1 Hour)
NOT COMPLETED
|
0
|
0
|
0
|
|
Third at Home Period (8-12 Days)
STARTED
|
8
|
8
|
8
|
|
Third at Home Period (8-12 Days)
COMPLETED
|
8
|
8
|
8
|
|
Third at Home Period (8-12 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Close-out Visit (30 Minutes)
STARTED
|
8
|
8
|
8
|
|
Close-out Visit (30 Minutes)
COMPLETED
|
8
|
8
|
8
|
|
Close-out Visit (30 Minutes)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Aerobic Exercise
Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.
Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study.
|
Anaerobic Exercise
Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.
Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study.
|
High Intensity Interval Exercise
Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.
Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study.
|
|---|---|---|---|
|
First at Home Period (9-14 Days)
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Evaluation of Physician-based Decision Support
Baseline characteristics by cohort
| Measure |
Aerobic Exercise
n=8 Participants
All study subjects were randomized to either aerobic, anaerobic or high intensity interval training. Subjects were on study for 28 days.
|
Anaerobic Exercise
n=8 Participants
All study subjects were randomized to either aerobic, anaerobic or high intensity interval training. Subjects were on study for 28 days.
|
High Intensity Interval Exercise
n=9 Participants
All study subjects were randomized to either aerobic, anaerobic or high intensity interval training. Subjects were on study for 28 days.
|
Total
n=25 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
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 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
|
31.8 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
28.6 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
29 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
29.8 years
STANDARD_DEVIATION 5.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 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
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
25 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Days 1-7Population: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.
Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using values uploaded to Dexcom Clarity. The percent of time with sensed glucose 70-180 mg/dl was averaged across days 1-7.
Outcome measures
| Measure |
Aerobic Exercise
n=8 Participants
Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
Anaerobic Exercise
n=8 Participants
Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
High Intensity Interval Exercise
n=8 Participants
Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
|---|---|---|---|
|
Percent of Time With Sensed Glucose 70-180 mg/dl
|
58.8 percentage of time
Standard Deviation 18.9
|
51.2 percentage of time
Standard Deviation 10.8
|
59.3 percentage of time
Standard Deviation 14.6
|
PRIMARY outcome
Timeframe: Days 1-7Population: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less than 70 mg/dl was averaged across days 1-7.
Outcome measures
| Measure |
Aerobic Exercise
n=8 Participants
Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
Anaerobic Exercise
n=8 Participants
Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
High Intensity Interval Exercise
n=8 Participants
Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
|---|---|---|---|
|
Percent of Time With Sensed Glucose Less Than 70 mg/dl
|
3.3 percentage of time
Standard Deviation 3.5
|
2.4 percentage of time
Standard Deviation 1.4
|
3.3 percentage of time
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: Days 22-28Population: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.
Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose 70-180 mg/dl was averaged across days 22-28.
Outcome measures
| Measure |
Aerobic Exercise
n=8 Participants
Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
Anaerobic Exercise
n=8 Participants
Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
High Intensity Interval Exercise
n=8 Participants
Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
|---|---|---|---|
|
Percent of Time With Sensed Glucose 70-180 mg/dl
|
53.6 percentage of time
Standard Deviation 13.6
|
51.0 percentage of time
Standard Deviation 16.0
|
50.4 percentage of time
Standard Deviation 13.4
|
PRIMARY outcome
Timeframe: Days 22-28Population: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 70 mg/dl was averaged across days 22-28.
Outcome measures
| Measure |
Aerobic Exercise
n=8 Participants
Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
Anaerobic Exercise
n=8 Participants
Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
High Intensity Interval Exercise
n=8 Participants
Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
|---|---|---|---|
|
Percent of Time With Sensed Glucose Less Than 70 mg/dl
|
3.8 percentage of time
Standard Deviation 3.4
|
2.2 percentage of time
Standard Deviation 2.4
|
3.1 percentage of time
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Days 1-7Population: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 54 mg/dl was averaged across days 1-7.
Outcome measures
| Measure |
Aerobic Exercise
n=8 Participants
Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
Anaerobic Exercise
n=8 Participants
Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
High Intensity Interval Exercise
n=8 Participants
Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
|---|---|---|---|
|
Percent of Time With Sensed Glucose Less Than 54 mg/dl
|
0.5 percentage of time
Standard Deviation 0.8
|
0.4 percentage of time
Standard Deviation 0.3
|
0.5 percentage of time
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Days 1-7Population: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.
Assess the mean Dexcom G6 reported sensor glucose values using values uploaded to Dexcom Clarity.The mean sensed glucose was averaged across days 1-7.
Outcome measures
| Measure |
Aerobic Exercise
n=8 Participants
Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
Anaerobic Exercise
n=8 Participants
Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
High Intensity Interval Exercise
n=8 Participants
Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
|---|---|---|---|
|
Mean Sensed Glucose
|
168.4 mg/dl
Standard Deviation 28.7
|
177.7 mg/dl
Standard Deviation 14.5
|
166.4 mg/dl
Standard Deviation 25.7
|
SECONDARY outcome
Timeframe: Days 22-28Population: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 54 mg/dl was averaged across days 22-28.
Outcome measures
| Measure |
Aerobic Exercise
n=8 Participants
Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
Anaerobic Exercise
n=8 Participants
Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
High Intensity Interval Exercise
n=8 Participants
Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
|---|---|---|---|
|
Percent of Time With Sensed Glucose Less Than 54 mg/dl
|
0.7 percentage of time
Standard Deviation 0.8
|
0.5 percentage of time
Standard Deviation 1.1
|
0.8 percentage of time
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Days 22-28Population: 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.
Assess the mean Dexcom G6 reported sensor glucose values using values uploaded to Dexcom Clarity.The mean sensed glucose was averaged across days 22-28.
Outcome measures
| Measure |
Aerobic Exercise
n=8 Participants
Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
Anaerobic Exercise
n=8 Participants
Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
High Intensity Interval Exercise
n=8 Participants
Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
|
|---|---|---|---|
|
Mean Sensed Glucose
|
174.0 mg/dl
Standard Deviation 22.1
|
184.1 mg/dl
Standard Deviation 25.2
|
183.0 mg/dl
Standard Deviation 33.1
|
Adverse Events
Aerobic Exercise
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Anaerobic Exercise
Serious events: 0 serious events
Other events: 0 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
| Measure |
Aerobic Exercise
n=8 participants at risk
Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.
Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study.
|
Anaerobic Exercise
n=8 participants at risk
Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.
Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study.
|
High Intensity Interval Exercise
n=9 participants at risk
Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.
Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Shoulder injury
|
0.00%
0/8 • 28 days
All participants that started a visit are included in the adverse events. All subjects completed all visits except one. That subject only completed the start up visit.
|
0.00%
0/8 • 28 days
All participants that started a visit are included in the adverse events. All subjects completed all visits except one. That subject only completed the start up visit.
|
11.1%
1/9 • Number of events 1 • 28 days
All participants that started a visit are included in the adverse events. All subjects completed all visits except one. That subject only completed the start up visit.
|
|
Skin and subcutaneous tissue disorders
redness and swelling at sensor site
|
12.5%
1/8 • Number of events 1 • 28 days
All participants that started a visit are included in the adverse events. All subjects completed all visits except one. That subject only completed the start up visit.
|
0.00%
0/8 • 28 days
All participants that started a visit are included in the adverse events. All subjects completed all visits except one. That subject only completed the start up visit.
|
0.00%
0/9 • 28 days
All participants that started a visit are included in the adverse events. All subjects completed all visits except one. That subject only completed the start up visit.
|
|
Infections and infestations
upper respiratory infection
|
12.5%
1/8 • Number of events 1 • 28 days
All participants that started a visit are included in the adverse events. All subjects completed all visits except one. That subject only completed the start up visit.
|
0.00%
0/8 • 28 days
All participants that started a visit are included in the adverse events. All subjects completed all visits except one. That subject only completed the start up visit.
|
11.1%
1/9 • Number of events 1 • 28 days
All participants that started a visit are included in the adverse events. All subjects completed all visits except one. That subject only completed the start up visit.
|
|
Vascular disorders
lightheadedness
|
0.00%
0/8 • 28 days
All participants that started a visit are included in the adverse events. All subjects completed all visits except one. That subject only completed the start up visit.
|
0.00%
0/8 • 28 days
All participants that started a visit are included in the adverse events. All subjects completed all visits except one. That subject only completed the start up visit.
|
11.1%
1/9 • Number of events 1 • 28 days
All participants that started a visit are included in the adverse events. All subjects completed all visits except one. That subject only completed the start up visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee OHSU shall submit for Dexcom's review and comment all publications which result from this Trial. Written copies of results shall be submitted to the Dexcom no later than 45 days before publication and Dexcom shall provide its comments within 30 days, which OHSU will incorporate and honor.
- Publication restrictions are in place
Restriction type: OTHER