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Evaluation of the Accuracy of an Implanted Glucose Sensor (PRECISEII)

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ClinicalTrials.gov Identifier: NCT02647905
Recruitment Status : Completed
First Posted : January 6, 2016
Results First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Senseonics, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Diabetes Mellitus
Intervention Device: Continuous Glucose Monitoring System
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Accuracy Assessment, CGMS
Hide Arm/Group Description

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

Period Title: Overall Study
Started 90
Completed 87
Not Completed 3
Reason Not Completed
Lost to Follow-up             1
Withdrawal by Subject             2
Arm/Group Title Accuracy Assessment, CGMS
Hide Arm/Group Description

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 Number of Baseline Participants 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants
45.1  (16.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
Female
36
  40.0%
Male
54
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
American Indian or Alaska Native
2
   2.2%
Asian
3
   3.3%
Native Hawaiian or Other Pacific Islander
1
   1.1%
Black or African American
7
   7.8%
White
77
  85.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 90 participants
90
Dominant Hand  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
Right
78
  86.7%
Left
12
  13.3%
Body mass Index  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
Normal (<25 kg/m2)
22
  24.4%
Overweight (≥25 and <30)
27
  30.0%
Obese (≥ 30)
41
  45.6%
Years since diabetes diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants
20.1  (13.7)
Diabetes Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
Type I
61
  67.8%
Type II
29
  32.2%
Type of insulin therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
None
20
  22.2%
Multiple daily injections
24
  26.7%
continuous insulin infusion pump
43
  47.8%
Other
3
   3.3%
History of  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
Ketoacidosis
0
   0.0%
Hypoglycemia
1
   1.1%
1.Primary Outcome
Title CGM Relative Difference to Laboratory Reference Reported as MARD
Hide Description 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.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Accuracy Assessment, CGMS
Hide Arm/Group Description:

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 Number of Participants Analyzed 87
Mean (95% Confidence Interval)
Unit of Measure: percent
8.5
(8.0 to 9.1)
2.Other Pre-specified Outcome
Title CGM System Agreement With Reference Control
Hide Description The percentage of system readings within ±15 mg/dL or 15% of YSI reference values (15/15%)
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Accuracy Assessment, CGMS
Hide Arm/Group Description:

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 Number of Participants Analyzed 87
Measure Type: Number
Unit of Measure: percent of readings within 15/15%
86.8
Time Frame 90 days post insertion or sensor removal and follow-up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Accuracy Assessment, CGMS
Hide Arm/Group Description

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

All-Cause Mortality
Accuracy Assessment, CGMS
Affected / at Risk (%)
Total   0/90 (0.00%)    
Hide Serious Adverse Events
Accuracy Assessment, CGMS
Affected / at Risk (%) # Events
Total   1/90 (1.11%)    
Surgical and medical procedures   
Surgical procedure to remove sensor  [1]  1/90 (1.11%)  1
Indicates events were collected by systematic assessment
[1]
PI requested assistance from a general surgeon for removal of sensor through outpatient surgery who then elected to place the patient under general anesthesia. The sensor was removed intact without incident
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Accuracy Assessment, CGMS
Affected / at Risk (%) # Events
Total   43/90 (47.78%)    
Eye disorders   
Cataracts  [1]  1/90 (1.11%)  1
Gastrointestinal disorders   
Sore throat  [1]  2/90 (2.22%)  2
Gastroenteritis  [1]  4/90 (4.44%)  4
Constipation  [1]  1/90 (1.11%)  1
Gastric ulcer  [1]  1/90 (1.11%)  1
Diarrhea  [1]  2/90 (2.22%)  2
Nausea  [1]  2/90 (2.22%)  2
General disorders   
Fever  [1]  1/90 (1.11%)  1
Fatigue  [1]  1/90 (1.11%)  1
Sensor location site- Pain/discomfort  [2]  3/90 (3.33%)  4
Immune system disorders   
Dermatitis  [1]  1/90 (1.11%)  1
Infections and infestations   
Infection-Tooth  [1]  1/90 (1.11%)  1
Laryngitis  [1]  1/90 (1.11%)  1
Cellulitis  [1]  1/90 (1.11%)  1
Injury, poisoning and procedural complications   
Food poisoning  [1]  1/90 (1.11%)  1
Cracked tooth  [1]  1/90 (1.11%)  1
Broken tooth  [1]  1/90 (1.11%)  1
IV site pain  [3]  1/90 (1.11%)  1
IV site Erythema  [3]  1/90 (1.11%)  1
Metabolism and nutrition disorders   
Dyslipidemia  [1]  1/90 (1.11%)  1
Musculoskeletal and connective tissue disorders   
Sciatica  [1]  1/90 (1.11%)  1
Shoulder pain  [1]  2/90 (2.22%)  2
Neck strain  [1]  1/90 (1.11%)  1
Broken toe  [1]  1/90 (1.11%)  1
Rib injury  [1]  1/90 (1.11%)  1
Sensor location site- Pain/discomfort  [2]  1/90 (1.11%)  1
Ankle sprain  [1]  1/90 (1.11%)  1
TMJ pain  [1]  1/90 (1.11%)  1
Nervous system disorders   
Carpal tunnel  [1]  1/90 (1.11%)  1
Dizziness  [1]  1/90 (1.11%)  1
Headache  [3]  4/90 (4.44%)  5
Paresthesia  [2]  1/90 (1.11%)  1
Renal and urinary disorders   
Nephrolithiasis  [1]  1/90 (1.11%)  1
Urinary tract infection  [1]  1/90 (1.11%)  1
Reproductive system and breast disorders   
Candidiasis vaginal  [1]  1/90 (1.11%)  1
Respiratory, thoracic and mediastinal disorders   
Common cold  [1]  4/90 (4.44%)  4
Infection-Upper Respiratory  [1]  1/90 (1.11%)  1
Bronchitis  [1]  1/90 (1.11%)  1
Cough  [1]  1/90 (1.11%)  1
Sleep apnea  [1]  1/90 (1.11%)  1
Skin and subcutaneous tissue disorders   
Bruising  [2]  1/90 (1.11%)  2
Erythema, removal site  [2]  1/90 (1.11%)  2
Ecchymosis  [1]  1/90 (1.11%)  1
Erythema, Arm  [3]  1/90 (1.11%)  1
Surgical and medical procedures   
Blepharoplasty  [1]  1/90 (1.11%)  1
Device Fragement not recovered  [2]  2/90 (2.22%)  2
Vascular disorders   
Syncope  [3]  2/90 (2.22%)  2
Syncope-Vasovagal  [2]  1/90 (1.11%)  1
Indicates events were collected by systematic assessment
[1]
Not related to Study device or insertion/removal procedure
[2]
Related or Possibly related to the study device or Insertion/Removal Procedure
[3]
Related or Possibly related to Study Procedure
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President, Clinical Sciences
Organization: Senseonics
Phone: 3015157260
EMail: katherine.tweden@senseonics.com
Layout table for additonal information
Responsible Party: Senseonics, Inc.
ClinicalTrials.gov Identifier: NCT02647905    
Other Study ID Numbers: CTP-0023
First Submitted: December 31, 2015
First Posted: January 6, 2016
Results First Submitted: April 2, 2018
Results First Posted: June 6, 2018
Last Update Posted: June 6, 2018