Trial Outcomes & Findings for Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics (NCT NCT03966911)
NCT ID: NCT03966911
Last Updated: 2021-06-07
Results Overview
Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™\*) reference value (within 20 mg/dL if sensor values \< 80 mg/dL), across all participants and all Frequent Sample Testing (FST) days. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
335 participants
Primary outcome timeframe
7 days (170 hours)
Results posted on
2021-06-07
Participant Flow
335 subjects (188 adult subjects and 147 pediatric subjects) consented and enrolled in the overall study. Of them, 311 subjects (169 adult subjects and 142 pediatric subjects) were eligible.
Participant milestones
| Measure |
Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3)
Adult subjects (age 18-80) wear Guardian™ Sensor (3) over 7 days and participate in FSTs.
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing
|
Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3)
Pediatric subjects (age 2-17) wear Guardian™ Sensor (3) over 7 days and participate in FSTs.
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing
|
|---|---|---|
|
Overall Study
STARTED
|
169
|
142
|
|
Overall Study
COMPLETED
|
160
|
126
|
|
Overall Study
NOT COMPLETED
|
9
|
16
|
Reasons for withdrawal
| Measure |
Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3)
Adult subjects (age 18-80) wear Guardian™ Sensor (3) over 7 days and participate in FSTs.
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing
|
Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3)
Pediatric subjects (age 2-17) wear Guardian™ Sensor (3) over 7 days and participate in FSTs.
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
2
|
|
Overall Study
Unable to complete study visits due to COVID-19
|
0
|
13
|
Baseline Characteristics
Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics
Baseline characteristics by cohort
| Measure |
Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3)
n=169 Participants
Adult subjects (age 18-80) wear Guardian™ Sensor (3) over 7 days and participate in FSTs.
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing
|
Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3)
n=142 Participants
Pediatric subjects (age 2-17) wear Guardian™ Sensor (3) over 7 days and participate in FSTs.
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing
|
Total
n=311 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 17.8 • n=99 Participants
|
10.9 years
STANDARD_DEVIATION 4.0 • n=107 Participants
|
29.9 years
STANDARD_DEVIATION 22.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
161 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
148 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
273 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
169 participants
n=99 Participants
|
142 participants
n=107 Participants
|
311 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 7 days (170 hours)Population: Subjects with at least 1 sensor-YSI (or sensor-SMBG for subjects 2-6 years) paired point during the sensor wear
Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™\*) reference value (within 20 mg/dL if sensor values \< 80 mg/dL), across all participants and all Frequent Sample Testing (FST) days. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI.
Outcome measures
| Measure |
Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3) on the Arm
n=169 Participants
Adult subjects (age 18-80) wear Guardian™ Sensor (3) on the arm over 7 days and participate in FSTs. Zero calibration sensor algorithm applied to raw sensor data.
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing
|
Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3) on the Abdomen
n=169 Participants
Adult subjects (age 18-80) wear Guardian™ Sensor (3) on the abdomen over 7 days and participate in FSTs. Zero calibration sensor algorithm applied to raw sensor data.
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing
|
Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3) on the Arm
n=142 Participants
Pediatric subjects (age 2-17) wear Guardian™ Sensor (3) on the arm over 7 days and participate in FSTs. Zero calibration sensor algorithm applied to raw sensor data.
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing
|
Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3) on the Buttock
n=142 Participants
Pediatric subjects (age 2-17) wear Guardian™ Sensor (3) on the buttock over 7 days and participate in FSTs. Zero calibration sensor algorithm applied to raw sensor data.
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing
|
|---|---|---|---|---|
|
Percentage of Readings Within 20% Agreement
|
88.00 Percentage of Readings
Interval 86.05 to 89.95
|
87.96 Percentage of Readings
Interval 86.13 to 89.8
|
84.59 Percentage of Readings
Interval 82.02 to 87.17
|
81.05 Percentage of Readings
Interval 77.58 to 84.53
|
Adverse Events
Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3)
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3)
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3)
n=169 participants at risk
Adult subjects (age 18-80) wear Guardian™ Sensor (3) over 7 days and participate in FSTs.
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing
|
Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3)
n=142 participants at risk
Pediatric subjects (age 2-17) wear Guardian™ Sensor (3) over 7 days and participate in FSTs.
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing
|
|---|---|---|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
0.70%
1/142 • Number of events 1 • Throughout the course of the study, up to 91 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
0.70%
1/142 • Number of events 1 • Throughout the course of the study, up to 91 days
|
Other adverse events
| Measure |
Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3)
n=169 participants at risk
Adult subjects (age 18-80) wear Guardian™ Sensor (3) over 7 days and participate in FSTs.
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing
|
Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3)
n=142 participants at risk
Pediatric subjects (age 2-17) wear Guardian™ Sensor (3) over 7 days and participate in FSTs.
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
0.70%
1/142 • Number of events 1 • Throughout the course of the study, up to 91 days
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
0.70%
1/142 • Number of events 1 • Throughout the course of the study, up to 91 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.70%
1/142 • Number of events 1 • Throughout the course of the study, up to 91 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
1.4%
2/142 • Number of events 2 • Throughout the course of the study, up to 91 days
|
|
Infections and infestations
Ear infection
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
0.70%
1/142 • Number of events 1 • Throughout the course of the study, up to 91 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
0.70%
1/142 • Number of events 1 • Throughout the course of the study, up to 91 days
|
|
Infections and infestations
Folliculitis
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
0.70%
1/142 • Number of events 1 • Throughout the course of the study, up to 91 days
|
|
Infections and infestations
Fungal skin infection
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
0.70%
1/142 • Number of events 1 • Throughout the course of the study, up to 91 days
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
1.4%
2/142 • Number of events 2 • Throughout the course of the study, up to 91 days
|
|
Nervous system disorders
Headache
|
2.4%
4/169 • Number of events 4 • Throughout the course of the study, up to 91 days
|
1.4%
2/142 • Number of events 2 • Throughout the course of the study, up to 91 days
|
|
Vascular disorders
Hot flush
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
2.8%
4/142 • Number of events 5 • Throughout the course of the study, up to 91 days
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
0.70%
1/142 • Number of events 1 • Throughout the course of the study, up to 91 days
|
|
Infections and infestations
Influenza
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
0.70%
1/142 • Number of events 1 • Throughout the course of the study, up to 91 days
|
|
General disorders
Infusion site pain
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
0.70%
1/142 • Number of events 1 • Throughout the course of the study, up to 91 days
|
|
General disorders
Medical device site bruise
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
General disorders
Medical device site haemorrhage
|
2.4%
4/169 • Number of events 4 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
0.70%
1/142 • Number of events 1 • Throughout the course of the study, up to 91 days
|
|
General disorders
Medical device site pain
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
1.4%
2/142 • Number of events 2 • Throughout the course of the study, up to 91 days
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
4.9%
7/142 • Number of events 8 • Throughout the course of the study, up to 91 days
|
|
Gastrointestinal disorders
Nausea
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Infections and infestations
Oral herpes
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
0.70%
1/142 • Number of events 1 • Throughout the course of the study, up to 91 days
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
0.70%
1/142 • Number of events 1 • Throughout the course of the study, up to 91 days
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
0.70%
1/142 • Number of events 1 • Throughout the course of the study, up to 91 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
0.70%
1/142 • Number of events 1 • Throughout the course of the study, up to 91 days
|
|
Nervous system disorders
Presyncope
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.2%
2/169 • Number of events 2 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Infections and infestations
Sinusitis
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Nervous system disorders
Syncope
|
1.8%
3/169 • Number of events 4 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Infections and infestations
Tooth infection
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
4/169 • Number of events 4 • Throughout the course of the study, up to 91 days
|
0.70%
1/142 • Number of events 1 • Throughout the course of the study, up to 91 days
|
|
Infections and infestations
Urinary tract infection
|
0.59%
1/169 • Number of events 1 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/169 • Throughout the course of the study, up to 91 days
|
1.4%
2/142 • Number of events 2 • Throughout the course of the study, up to 91 days
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
2/169 • Number of events 2 • Throughout the course of the study, up to 91 days
|
0.00%
0/142 • Throughout the course of the study, up to 91 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60