Trial Outcomes & Findings for Evaluation of the Accuracy of an Implanted Glucose Sensor (NCT NCT02647905)
NCT ID: NCT02647905
Last Updated: 2018-06-06
Results Overview
Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 90 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
90 days
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
Accuracy Assessment, CGMS
To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days
Continuous Glucose Monitoring System: Accuracy and safety assessment of a continuous glucose monitoring device
|
|---|---|
|
Overall Study
STARTED
|
90
|
|
Overall Study
COMPLETED
|
87
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Accuracy Assessment, CGMS
To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days
Continuous Glucose Monitoring System: Accuracy and safety assessment of a continuous glucose monitoring device
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Evaluation of the Accuracy of an Implanted Glucose Sensor
Baseline characteristics by cohort
| Measure |
Accuracy Assessment, CGMS
n=90 Participants
To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days
Continuous Glucose Monitoring System: Accuracy and safety assessment of a continuous glucose monitoring device
|
|---|---|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
90 Participants
n=5 Participants
|
|
Dominant Hand
Right
|
78 Participants
n=5 Participants
|
|
Dominant Hand
Left
|
12 Participants
n=5 Participants
|
|
Body mass Index
Normal (<25 kg/m2)
|
22 Participants
n=5 Participants
|
|
Body mass Index
Overweight (≥25 and <30)
|
27 Participants
n=5 Participants
|
|
Body mass Index
Obese (≥ 30)
|
41 Participants
n=5 Participants
|
|
Years since diabetes diagnosis
|
20.1 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Diabetes Type
Type I
|
61 Participants
n=5 Participants
|
|
Diabetes Type
Type II
|
29 Participants
n=5 Participants
|
|
Type of insulin therapy
None
|
20 Participants
n=5 Participants
|
|
Type of insulin therapy
Multiple daily injections
|
24 Participants
n=5 Participants
|
|
Type of insulin therapy
continuous insulin infusion pump
|
43 Participants
n=5 Participants
|
|
Type of insulin therapy
Other
|
3 Participants
n=5 Participants
|
|
History of
Ketoacidosis
|
0 Participants
n=5 Participants
|
|
History of
Hypoglycemia
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysMean absolute relative difference (MARD) for paired Sensor and reference measurements through 90 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison.
Outcome measures
| Measure |
Accuracy Assessment, CGMS
n=87 Participants
To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days
Continuous Glucose Monitoring System: Accuracy and safety assessment of a continuous glucose monitoring device
|
|---|---|
|
CGM Relative Difference to Laboratory Reference Reported as MARD
|
8.5 percent
Interval 8.0 to 9.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 daysThe percentage of system readings within ±15 mg/dL or 15% of YSI reference values (15/15%)
Outcome measures
| Measure |
Accuracy Assessment, CGMS
n=87 Participants
To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days
Continuous Glucose Monitoring System: Accuracy and safety assessment of a continuous glucose monitoring device
|
|---|---|
|
CGM System Agreement With Reference Control
|
86.8 percent of readings within 15/15%
|
Adverse Events
Accuracy Assessment, CGMS
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Accuracy Assessment, CGMS
n=90 participants at risk
To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days
Continuous Glucose Monitoring System: Accuracy and safety assessment of a continuous glucose monitoring device
|
|---|---|
|
Surgical and medical procedures
Surgical procedure to remove sensor
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
Other adverse events
| Measure |
Accuracy Assessment, CGMS
n=90 participants at risk
To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days
Continuous Glucose Monitoring System: Accuracy and safety assessment of a continuous glucose monitoring device
|
|---|---|
|
Injury, poisoning and procedural complications
Food poisoning
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Vascular disorders
Syncope
|
2.2%
2/90 • Number of events 2 • 90 days post insertion or sensor removal and follow-up
|
|
Nervous system disorders
Carpal tunnel
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Nervous system disorders
Dizziness
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Nervous system disorders
Headache
|
4.4%
4/90 • Number of events 5 • 90 days post insertion or sensor removal and follow-up
|
|
Nervous system disorders
Paresthesia
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Vascular disorders
Syncope-Vasovagal
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Musculoskeletal and connective tissue disorders
Sciatica
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
2.2%
2/90 • Number of events 2 • 90 days post insertion or sensor removal and follow-up
|
|
Musculoskeletal and connective tissue disorders
Neck strain
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Musculoskeletal and connective tissue disorders
Broken toe
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Musculoskeletal and connective tissue disorders
Rib injury
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Musculoskeletal and connective tissue disorders
Sensor location site- Pain/discomfort
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Musculoskeletal and connective tissue disorders
Ankle sprain
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Renal and urinary disorders
Urinary tract infection
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Reproductive system and breast disorders
Candidiasis vaginal
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Metabolism and nutrition disorders
Dyslipidemia
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
General disorders
Fever
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Common cold
|
4.4%
4/90 • Number of events 4 • 90 days post insertion or sensor removal and follow-up
|
|
Gastrointestinal disorders
Sore throat
|
2.2%
2/90 • Number of events 2 • 90 days post insertion or sensor removal and follow-up
|
|
Injury, poisoning and procedural complications
Cracked tooth
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Infections and infestations
Infection-Tooth
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Infections and infestations
Laryngitis
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Eye disorders
Cataracts
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Infection-Upper Respiratory
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Surgical and medical procedures
Blepharoplasty
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Injury, poisoning and procedural complications
Broken tooth
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Musculoskeletal and connective tissue disorders
TMJ pain
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Surgical and medical procedures
Device Fragement not recovered
|
2.2%
2/90 • Number of events 2 • 90 days post insertion or sensor removal and follow-up
|
|
General disorders
Fatigue
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Skin and subcutaneous tissue disorders
Bruising
|
1.1%
1/90 • Number of events 2 • 90 days post insertion or sensor removal and follow-up
|
|
Skin and subcutaneous tissue disorders
Erythema, removal site
|
1.1%
1/90 • Number of events 2 • 90 days post insertion or sensor removal and follow-up
|
|
General disorders
Sensor location site- Pain/discomfort
|
3.3%
3/90 • Number of events 4 • 90 days post insertion or sensor removal and follow-up
|
|
Injury, poisoning and procedural complications
IV site pain
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Immune system disorders
Dermatitis
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Infections and infestations
Cellulitis
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Injury, poisoning and procedural complications
IV site Erythema
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Gastrointestinal disorders
Gastroenteritis
|
4.4%
4/90 • Number of events 4 • 90 days post insertion or sensor removal and follow-up
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
2/90 • Number of events 2 • 90 days post insertion or sensor removal and follow-up
|
|
Gastrointestinal disorders
Nausea
|
2.2%
2/90 • Number of events 2 • 90 days post insertion or sensor removal and follow-up
|
|
Skin and subcutaneous tissue disorders
Erythema, Arm
|
1.1%
1/90 • Number of events 1 • 90 days post insertion or sensor removal and follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60