Trial Outcomes & Findings for Feasibility Studies of Personalized Closed Loop (NCT NCT04203823)
NCT ID: NCT04203823
Last Updated: 2023-05-09
Results Overview
Number of severe hypoglycemic events occurred in the study in Cohort A
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
126 participants
Primary outcome timeframe
approximately 3.5 months
Results posted on
2023-05-09
Participant Flow
Participant milestones
| Measure |
Cohort A
The main purpose of this cohort is to test the Digital Twin insulin delivery algorithm adaptation
Cloud-based Digital Twin algorithms: Test safety and effectiveness of the Digital Twin algorithms
|
Cohort C
The main purpose of this cohort is to test a meal prediction algorithm
Cloud-based Meal Prediction algorithms: Test safety and effectiveness of the Meal Prediction algorithms
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
72
|
|
Overall Study
COMPLETED
|
51
|
65
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
Cohort A
The main purpose of this cohort is to test the Digital Twin insulin delivery algorithm adaptation
Cloud-based Digital Twin algorithms: Test safety and effectiveness of the Digital Twin algorithms
|
Cohort C
The main purpose of this cohort is to test a meal prediction algorithm
Cloud-based Meal Prediction algorithms: Test safety and effectiveness of the Meal Prediction algorithms
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Parent/Guardian
|
0
|
4
|
Baseline Characteristics
Feasibility Studies of Personalized Closed Loop
Baseline characteristics by cohort
| Measure |
Cohort A
n=54 Participants
The main purpose of this cohort is to test the Digital Twin insulin delivery algorithm adaptation
Cloud-based Digital Twin algorithms: Test safety and effectiveness of the Digital Twin algorithms
|
Cohort C
n=72 Participants
The main purpose of this cohort is to test a meal prediction algorithm
Cloud-based Meal Prediction algorithms: Test safety and effectiveness of the Meal Prediction algorithms
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.2 years
STANDARD_DEVIATION 19.2 • n=5 Participants
|
34.8 years
STANDARD_DEVIATION 19.5 • n=7 Participants
|
35.0 years
STANDARD_DEVIATION 19.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
50 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native, White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
72 participants
n=7 Participants
|
126 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: approximately 3.5 monthsNumber of severe hypoglycemic events occurred in the study in Cohort A
Outcome measures
| Measure |
Cohort A
n=54 Participants
The main purpose of this cohort is to test the Digital Twin insulin delivery algorithm adaptation
Cloud-based Digital Twin algorithms: Test safety and effectiveness of the Digital Twin algorithms
|
|---|---|
|
Number of Severe Hypoglycemic Event - Cohort A
|
0 events
|
PRIMARY outcome
Timeframe: approximately 3.5 monthsNumber of Diabetic Ketoacidosis (DKA) event occurred in the study in Cohort A
Outcome measures
| Measure |
Cohort A
n=54 Participants
The main purpose of this cohort is to test the Digital Twin insulin delivery algorithm adaptation
Cloud-based Digital Twin algorithms: Test safety and effectiveness of the Digital Twin algorithms
|
|---|---|
|
Number of Diabetic Ketoacidosis (DKA) Event - Cohort A
|
0 events
|
PRIMARY outcome
Timeframe: approximately 3.5 monthsPopulation: Participants in Cohort A with device data (1 did not have device data)
The overall mean percentage of time in Euglycemia (70-180 mg/dL) in Cohort A
Outcome measures
| Measure |
Cohort A
n=53 Participants
The main purpose of this cohort is to test the Digital Twin insulin delivery algorithm adaptation
Cloud-based Digital Twin algorithms: Test safety and effectiveness of the Digital Twin algorithms
|
|---|---|
|
Percentage of Time in Euglycemia - Cohort A
|
70.5 percentage of time
Standard Deviation 10.7
|
PRIMARY outcome
Timeframe: approximately 3.5 monthsNumber of severe hypoglycemic events occurred in the study in Cohort C
Outcome measures
| Measure |
Cohort A
n=72 Participants
The main purpose of this cohort is to test the Digital Twin insulin delivery algorithm adaptation
Cloud-based Digital Twin algorithms: Test safety and effectiveness of the Digital Twin algorithms
|
|---|---|
|
Number of Severe Hypoglycemic Event - Cohort C
|
0 events
|
PRIMARY outcome
Timeframe: approximately 3.5 monthsNumber of Diabetic Ketoacidosis (DKA) event occurred in the study in Cohort C
Outcome measures
| Measure |
Cohort A
n=72 Participants
The main purpose of this cohort is to test the Digital Twin insulin delivery algorithm adaptation
Cloud-based Digital Twin algorithms: Test safety and effectiveness of the Digital Twin algorithms
|
|---|---|
|
Number of Diabetic Ketoacidosis (DKA) Event - Cohort C
|
0 events
|
PRIMARY outcome
Timeframe: approximately 3.5 monthsPopulation: Participants in Cohort C with device data (10 did not have device data)
The overall mean percentage of time in Euglycemia (70-180 mg/dL) in Cohort C
Outcome measures
| Measure |
Cohort A
n=62 Participants
The main purpose of this cohort is to test the Digital Twin insulin delivery algorithm adaptation
Cloud-based Digital Twin algorithms: Test safety and effectiveness of the Digital Twin algorithms
|
|---|---|
|
Percentage of Time in Euglycemia - Cohort C
|
77 percentage of time
Standard Deviation 8
|
Adverse Events
Cohort A
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Cohort C
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort A
n=54 participants at risk
The main purpose of this cohort is to test the Digital Twin insulin delivery algorithm adaptation
Cloud-based Digital Twin algorithms: Test safety and effectiveness of the Digital Twin algorithms
|
Cohort C
n=72 participants at risk
The main purpose of this cohort is to test a meal prediction algorithm
Cloud-based Meal Prediction algorithms: Test safety and effectiveness of the Meal Prediction algorithms
|
|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
1.4%
1/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
1.9%
1/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
0.00%
0/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Infections and infestations
Respiratory tract infection
|
3.7%
2/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
0.00%
0/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Infections and infestations
COVID-19
|
0.00%
0/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
2.8%
2/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
1.4%
1/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
2.8%
2/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Infections and infestations
Viral infection
|
0.00%
0/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
1.4%
1/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
1.4%
1/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
2.8%
2/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Immune system disorders
Immunisation reaction
|
0.00%
0/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
1.4%
1/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
1.4%
1/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Investigations
Epstein-Barr virus test positive
|
1.9%
1/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
0.00%
0/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.6%
3/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
8.3%
6/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
1.4%
1/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
1.4%
1/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.9%
1/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
0.00%
0/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
0.00%
0/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
1.4%
1/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.9%
1/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
0.00%
0/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.9%
1/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
0.00%
0/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
1.9%
1/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
0.00%
0/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
1.9%
1/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
0.00%
0/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
1.4%
1/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
|
Vascular disorders
Hypertension
|
1.9%
1/54 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
0.00%
0/72 • Individual subjects were participating in Feasibility 2 for approximately 3.5 months.
Investigators were instructed to monitor the subjects throughout the course of the study for the occurrence of an adverse event. Adverse events were to be documented in the subject study file and reported to the sponsor on an eCRF. Medtronic study Monitors conducted study site visits and monitored subject source documents to reconcile reported adverse events and for possible detection of additional adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60