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Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform

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ClinicalTrials.gov Identifier: NCT02750267
Recruitment Status : Completed
First Posted : April 25, 2016
Results First Posted : June 23, 2017
Last Update Posted : July 24, 2017
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
Mark DeBoer, MD, University of Virginia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Intervention Device: Diabetes Assistant (DiAs) with Closed-Loop
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A- Home Care Before Closed-Loop Control Group B- Closed-Loop Control Before Home Care
Hide Arm/Group Description

In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel. All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system). Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission. Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission.

Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.

Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission. Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission. As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission.

Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.

Period Title: Overall Study
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title Group A- Home Care Before Closed-Loop Control Group B- Closed-Loop Control Before Home Care Total
Hide Arm/Group Description

In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel. All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system). Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission. Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission.

Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.

Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission. Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission. As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission.

Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.

Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
7
(6.25 to 7.75)
7
(7 to 7)
7
(6.75 to 7.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
3
  50.0%
3
  50.0%
6
  50.0%
Male
3
  50.0%
3
  50.0%
6
  50.0%
HbA1c  
Median (Inter-Quartile Range)
Unit of measure:  Percentage of HbA1C
Number Analyzed 6 participants 6 participants 12 participants
7.7
(7.2 to 7.8)
7.6
(7.1 to 7.8)
7.7
(7.1 to 7.8)
Diabetes Duration  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
4.9
(2.2 to 6.1)
3.3
(3.2 to 5.0)
3.7
(2.9 to 5.7)
1.Primary Outcome
Title Percent of Sensor Glucose Readings Between 70-180 mg/dL
Hide Description All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Time Frame 68 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Hide Arm/Group Description:
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: percentage of time in range
46.9  (2.7) 73.1  (2.7)
2.Secondary Outcome
Title Percent of Time Sensor Glucose Readings Are <70 mg/dL
Hide Description All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Time Frame 68 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Hide Arm/Group Description:
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: percentage of time below 70 mg/dL
1.6  (1.2) 1.1  (1.1)
3.Secondary Outcome
Title Percent of Time Sensor Glucose Readings Are >150 mg/dL
Hide Description All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Hide Arm/Group Description:
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Percent of Time Sensor Glucose Readings Are >180 mg/dL
Hide Description All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Time Frame 68 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Hide Arm/Group Description:
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: percentage of time above 180 mg/dL
51.5  (0.8) 25.8  (2.8)
5.Secondary Outcome
Title Percent of Time Sensor Glucose Readings Are >250 mg/dL
Hide Description All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Time Frame 68 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Hide Arm/Group Description:
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: percentage of time above 250 mg/dL
20.8  (9.9) 6.3  (5.4)
6.Secondary Outcome
Title Percent of Time Sensor Glucose Readings Are >400 mg/dL
Hide Description All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Hide Arm/Group Description:
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Distribution of Sensor and Meter Glucose Values (Maximum, Minimum, Median, Interquartile Range, Mean, Standard Deviation)
Hide Description All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Hide Arm/Group Description:
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Distribution of Sensor and Meter Glucose Values (Maximum)
Hide Description All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Hide Arm/Group Description:
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Distribution of Sensor and Meter Glucose Values (Minimum)
Hide Description All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Hide Arm/Group Description:
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Distribution of Sensor and Meter Glucose Values (Median/Interquartile Range)
Hide Description All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Hide Arm/Group Description:
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Mean BG (as Measured by CGM)
Hide Description All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
Time Frame 68 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Hide Arm/Group Description:
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: mg/dL
190  (7.4) 152  (4.2)
12.Secondary Outcome
Title Hypoglycemia Area Under the Curve <60
Hide Description All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Hide Arm/Group Description:
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Hypoglycemia Area Under the Curve <70 mg/dL
Hide Description All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Hide Arm/Group Description:
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Hyperglycemia Area Under the Curve >180
Hide Description All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Hide Arm/Group Description:
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Hyperglycemia Area Under the Curve >250 mg/dL
Hide Description All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Hide Arm/Group Description:
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. The current secondary outcome was not specifically analyzed.
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The current secondary outcome was not specifically analyzed.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL
Hide Description All subjects have hypoglycemia monitored by meter analysis and compared between time on closed-loop system and time on usual care period.
Time Frame 68 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Hide Arm/Group Description:
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: events per subject, glucometer <70mg/dL
4.0  (1.0) 3.3  (1.0)
17.Secondary Outcome
Title End of Night Blood Glucose
Hide Description All subjects have blood glucose evaluated upon rising (approximately 7 am) and compared between time on closed-loop system and time on usual care period.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Hide Arm/Group Description:
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data was collect over two 72 hour periods for each subject. Over the entire study, adverse events were collected over a 216 hour period (Group A's 72 hr home period, 72 hr hotel period, Group B's 72 hr home period).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Hide Arm/Group Description All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission. All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
All-Cause Mortality
Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Home Care (Pump+CGM) Diabetes Assistant (DiAs) With Closed-Loop Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      1/12 (8.33%)    
Musculoskeletal and connective tissue disorders     
Sore Knee *  0/12 (0.00%)  0 1/12 (8.33%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Daniel R. Chernavvsky
Organization: Center for Diabetes Technology
Phone: 4342431395
EMail: drc2v@virginia.edu
Layout table for additonal information
Responsible Party: Mark DeBoer, MD, University of Virginia
ClinicalTrials.gov Identifier: NCT02750267     History of Changes
Other Study ID Numbers: 18888
First Submitted: April 15, 2016
First Posted: April 25, 2016
Results First Submitted: May 30, 2017
Results First Posted: June 23, 2017
Last Update Posted: July 24, 2017