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Single Hormone Closed Loop Study With PDT Sensor

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ClinicalTrials.gov Identifier: NCT03528174
Recruitment Status : Completed
First Posted : May 17, 2018
Results First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Jessica Castle, Oregon Health and Science University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Device Feasibility
Condition Type 1 Diabetes Mellitus
Interventions Device: Artificial Pancreas Control system (APC)
Device: Pacific Diabetes Technologies CGM Insulin Infusion system
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Hormone Closed Loop
Hide Arm/Group Description

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system

Period Title: Overall Study
Started 10
Completed 8
Not Completed 2
Reason Not Completed
Adverse Event             1
sensors dislodged             1
Arm/Group Title Single Hormone Closed Loop
Hide Arm/Group Description

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
7
  70.0%
Male
3
  30.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
10
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
8
  80.0%
More than one race
2
  20.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Mean Absolute Relative Difference of Sensed Glucose Values
Hide Description Assess the mean absolute relative difference for the PDT CGM/insulin infusion system based on all reference YSI venous blood glucose values.
Time Frame up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Hormone Closed Loop
Hide Arm/Group Description:

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: percentage of reference blood glucose
13.5  (4.6)
2.Secondary Outcome
Title Percent of Time With Sensed Glucose Between 70-180 mg/dl
Hide Description Assess the percent of time with sensed glucose between 70-180 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.
Time Frame up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Hormone Closed Loop
Hide Arm/Group Description:

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: percentage of time
59.8  (27.42)
3.Secondary Outcome
Title Percent of Time With Sensed Glucose Less Than 70 mg/dl
Hide Description Assess the percent of time with sensed glucose less than 70 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.
Time Frame up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Hormone Closed Loop
Hide Arm/Group Description:

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: percentage of time
3.3  (7)
4.Secondary Outcome
Title Percent of Time With Sensed Glucose Less Than 54 mg/dl
Hide Description Assess the percent of time with sensed glucose less than 54 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.
Time Frame up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Hormone Closed Loop
Hide Arm/Group Description:

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: percentage of time
0.3  (0.7)
5.Secondary Outcome
Title Percent of Time With Sensed Glucose Greater Than 250 mg/dl
Hide Description Assess the percent of time with sensed glucose greater than 250 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.
Time Frame up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Hormone Closed Loop
Hide Arm/Group Description:

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: percentage of time
12.4  (17.7)
6.Secondary Outcome
Title Mean Sensed Glucose
Hide Description Assess the average sensor glucose based on the Dexcom G5 CGM sensor values.
Time Frame up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Hormone Closed Loop
Hide Arm/Group Description:

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: mg/dL
167.8  (71)
7.Secondary Outcome
Title Number of Carbohydrate Treatments
Hide Description Assess the average number of carbohydrate treatments per study defined as 15 or 20 grams of carbohydrates.
Time Frame up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Hormone Closed Loop
Hide Arm/Group Description:

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: carbohydrate treatments
0.6  (1.9)
8.Secondary Outcome
Title Mean Amount of Insulin Delivered
Hide Description Assess the average amount of insulin delivered per study in units/kg.
Time Frame up to 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Hormone Closed Loop
Hide Arm/Group Description:

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units/kg
0.24  (0.11)
9.Secondary Outcome
Title Mean Score of Visual Analog Scale at 15 Minutes
Hide Description Assess the average score on the visual analog scale at 15 minutes after insertion of the PDT glucose sensor. This scale will be used to measure sensor site discomfort from the PDT glucose sensing cannula. The subject completes the visual analog scale by drawing a single vertical line through a 100 mm line corresponding to the perceived intensity (severity) of discomfort from the insertion of the sensors. Subjects will be instructed to mark their line starting on the left side over to the right side. If subjects are feeling no discomfort, they would circle the vertical line on the left end of the scale. If subjects are currently feeling the worst discomfort possible, they would circle the vertical line on the right side of the scale. One staff member will measure all scales and document score as a measurement of 0-100.
Time Frame 15 minutes post insertion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Hormone Closed Loop
Hide Arm/Group Description:

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: mm
6.4  (8.3)
10.Secondary Outcome
Title Mean Score of Visual Analog Scale at 120 Minutes
Hide Description Assess the average score on the visual analog scale at 120 minutes after insertion of the PDT glucose sensor.This scale will be used to measure sensor site discomfort from the PDT glucose sensing cannula. The subject completes the visual analog scale by drawing a single vertical line through a 100 mm line corresponding to the perceived intensity (severity) of discomfort since the devices were inserted. Subjects will be instructed to mark their line starting on the left side to the right side. If subjects are feeling no discomfort, they would circle the vertical line on the left end of the scale. If subjects are currently feeling the worst discomfort possible, they would circle the vertical line on the right side of the scale. One staff member will measure all scales and document score as a measurement of 0-100.
Time Frame 120 minutes post insertion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Hormone Closed Loop
Hide Arm/Group Description:

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: mm
0.7  (1.3)
11.Secondary Outcome
Title Mean Score of Visual Analog Scale at End of Study
Hide Description Assess the average score on the visual analog scale at the end of the study. This scale will be used to measure sensor site discomfort from the PDT glucose sensing cannula. The subject completes the visual analog scale by drawing a single vertical line through a 100 mm line corresponding to the perceived intensity (severity) of discomfort since the devices were inserted. Subjects will be instructed to mark their line starting on the left side to the right side. If subjects are feeling no discomfort, they would circle the vertical line on the left end of the scale. If subjects are currently feeling the worst discomfort possible, they would circle the vertical line on the right side of the scale. One staff member will measure all scales and document score as a measurement of 0-100.
Time Frame End of 10 hour study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Hormone Closed Loop
Hide Arm/Group Description:

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: mm
8.9  (21.7)
12.Secondary Outcome
Title Mean Draize Scale for Erythema for the Left Sensing Cannula at End of Study for All Subjects
Hide Description Assess the average score on the Draize scale at the end of the study of the PDT glucose sensor. The investigator discharging the subject will inspect each PDT glucose sensing cannula insertion site and rate the level of redness (erythema) and swelling (edema). Both the left and right insertion sites will be inspected. Erythema will be measured from 0-4. A score of 0 indicates no erythema, a score of 1 indicates very slight, barely perceptible erythema, a score of 2 indicates well defined erythema, a score of 3 indicates moderate erythema, and a score of 4 indicates severe erythema, beet redness to slight eschar formation. Edema will be measured from a score of 0-4. A score of 0 indicates no edema, a score of 1 indicates very slight, barely perceptible edema, a score of 2 indicates well defined edema, a score of 3 indicates moderate edema, raised approximately 1 mm, and a score of 4 indicates severe edema, raised greater than 1 mm and beyond exposure area.
Time Frame End of 10 hour study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Hormone Closed Loop
Hide Arm/Group Description:

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.2  (0.4)
13.Secondary Outcome
Title Mean Draize Scale for Edema for the Left Sensing Cannula at End of Study for All Subjects
Hide Description Assess the average score on the Draize scale at the end of the study of the PDT glucose sensor. The investigator discharging the subject will inspect each PDT glucose sensing cannula insertion site and rate the level of redness (erythema) and swelling (edema). Both the left and right insertion sites will be inspected. Erythema will be measured from 0-4. A score of 0 indicates no erythema, a score of 1 indicates very slight, barely perceptible erythema, a score of 2 indicates well defined erythema, a score of 3 indicates moderate erythema, and a score of 4 indicates severe erythema, beet redness to slight eschar formation. Edema will be measured from a score of 0-4. A score of 0 indicates no edema, a score of 1 indicates very slight, barely perceptible edema, a score of 2 indicates well defined edema, a score of 3 indicates moderate edema, raised approximately 1 mm, and a score of 4 indicates severe edema, raised greater than 1 mm and beyond exposure area.
Time Frame end of 10 hour study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Hormone Closed Loop
Hide Arm/Group Description:

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.15  (0.37)
14.Secondary Outcome
Title Mean Draize Scale for Erythema for the Right Sensing Cannula at End of Study for All Subjects
Hide Description Assess the average score on the Draize scale at the end of the study of the PDT glucose sensor. The investigator discharging the subject will inspect each PDT glucose sensing cannula insertion site and rate the level of redness (erythema) and swelling (edema). Both the left and right insertion sites will be inspected. Erythema will be measured from 0-4. A score of 0 indicates no erythema, a score of 1 indicates very slight, barely perceptible erythema, a score of 2 indicates well defined erythema, a score of 3 indicates moderate erythema, and a score of 4 indicates severe erythema, beet redness to slight eschar formation. Edema will be measured from a score of 0-4. A score of 0 indicates no edema, a score of 1 indicates very slight, barely perceptible edema, a score of 2 indicates well defined edema, a score of 3 indicates moderate edema, raised approximately 1 mm, and a score of 4 indicates severe edema, raised greater than 1 mm and beyond exposure area.
Time Frame End of 10 hour study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Hormone Closed Loop
Hide Arm/Group Description:

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.2  (0.4)
15.Secondary Outcome
Title Mean Draize Scale for Edema for the Left Sensing Cannula at End of Study for All Subjects
Hide Description Assess the average score on the Draize scale at the end of the study of the PDT glucose sensor. The investigator discharging the subject will inspect each PDT glucose sensing cannula insertion site and rate the level of redness (erythema) and swelling (edema). Both the left and right insertion sites will be inspected. Erythema will be measured from 0-4. A score of 0 indicates no erythema, a score of 1 indicates very slight, barely perceptible erythema, a score of 2 indicates well defined erythema, a score of 3 indicates moderate erythema, and a score of 4 indicates severe erythema, beet redness to slight eschar formation. Edema will be measured from a score of 0-4. A score of 0 indicates no edema, a score of 1 indicates very slight, barely perceptible edema, a score of 2 indicates well defined edema, a score of 3 indicates moderate edema, raised approximately 1 mm, and a score of 4 indicates severe edema, raised greater than 1 mm and beyond exposure area.
Time Frame end of 10 hour study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Hormone Closed Loop
Hide Arm/Group Description:

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.2  (0.4)
Time Frame Up to 10 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Hormone Closed Loop
Hide Arm/Group Description

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Artificial Pancreas Control system (APC): This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Pacific Diabetes Technologies CGM Insulin Infusion system: An integrated combination CGM/insulin infusion system

All-Cause Mortality
Single Hormone Closed Loop
Affected / at Risk (%)
Total   0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Single Hormone Closed Loop
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
Gastrointestinal disorders   
hospitalization for emesis * [1]  1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Hospitalization for persistant emesis and nausea
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Hormone Closed Loop
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
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: Jessica Castle MD
Organization: Oregon Health and Science University
Phone: 503-494-7072
EMail: castleje@ohsu.edu
Layout table for additonal information
Responsible Party: Jessica Castle, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03528174     History of Changes
Other Study ID Numbers: 18241
First Submitted: April 26, 2018
First Posted: May 17, 2018
Results First Submitted: May 31, 2019
Results First Posted: September 12, 2019
Last Update Posted: September 12, 2019