Trial Outcomes & Findings for Single Hormone Closed Loop Study With PDT Sensor (NCT NCT03528174)

NCT ID: NCT03528174

Last Updated: 2019-09-12

Results Overview

Assess the mean absolute relative difference for the PDT CGM/insulin infusion system based on all reference YSI venous blood glucose values.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: up to 10 hours
• Results posted on: 2019-09-12

Participant Flow

Participant milestones

Measure	Single Hormone Closed Loop 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 Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Single Hormone Closed Loop 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 Study Adverse Event	1
Overall Study sensors dislodged	1

Baseline Characteristics

Single Hormone Closed Loop Study With PDT Sensor

Baseline characteristics by cohort

Measure	Single Hormone Closed Loop n=10 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 10 hours

Assess the mean absolute relative difference for the PDT CGM/insulin infusion system based on all reference YSI venous blood glucose values.

Outcome measures

Measure

Single Hormone Closed Loop n=10 Participants 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

Mean Absolute Relative Difference of Sensed Glucose Values

13.5 percentage of reference blood glucose Standard Deviation 4.6

SECONDARY outcome

Timeframe: up to 10 hours

Assess the percent of time with sensed glucose between 70-180 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.

Outcome measures

Measure

Single Hormone Closed Loop n=10 Participants 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

Percent of Time With Sensed Glucose Between 70-180 mg/dl

59.8 percentage of time Standard Deviation 27.42

SECONDARY outcome

Timeframe: up to 10 hours

Assess the percent of time with sensed glucose less than 70 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.

Outcome measures

Measure

Single Hormone Closed Loop n=10 Participants 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

Percent of Time With Sensed Glucose Less Than 70 mg/dl

3.3 percentage of time Standard Deviation 7

SECONDARY outcome

Timeframe: up to 10 hours

Assess the percent of time with sensed glucose less than 54 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.

Outcome measures

Measure

Single Hormone Closed Loop n=10 Participants 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

Percent of Time With Sensed Glucose Less Than 54 mg/dl

0.3 percentage of time Standard Deviation 0.7

SECONDARY outcome

Timeframe: up to 10 hours

Assess the percent of time with sensed glucose greater than 250 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.

Outcome measures

Measure

Single Hormone Closed Loop n=10 Participants 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

Percent of Time With Sensed Glucose Greater Than 250 mg/dl

12.4 percentage of time Standard Deviation 17.7

SECONDARY outcome

Timeframe: up to 10 hours

Assess the average sensor glucose based on the Dexcom G5 CGM sensor values.

Outcome measures

Measure

Single Hormone Closed Loop n=10 Participants 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

Mean Sensed Glucose

167.8 mg/dL Standard Deviation 71

SECONDARY outcome

Timeframe: up to 10 hours

Assess the average number of carbohydrate treatments per study defined as 15 or 20 grams of carbohydrates.

Outcome measures

Measure

Single Hormone Closed Loop n=10 Participants 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

Number of Carbohydrate Treatments

0.6 carbohydrate treatments Standard Deviation 1.9

SECONDARY outcome

Timeframe: up to 10 hours

Assess the average amount of insulin delivered per study in units/kg.

Outcome measures

Measure

Single Hormone Closed Loop n=10 Participants 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

Mean Amount of Insulin Delivered

0.24 units/kg Standard Deviation 0.11

SECONDARY outcome

Timeframe: 15 minutes post insertion

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.

Outcome measures

Measure

Single Hormone Closed Loop n=10 Participants 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

Mean Score of Visual Analog Scale at 15 Minutes

6.4 mm Standard Deviation 8.3

SECONDARY outcome

Timeframe: 120 minutes post insertion

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.

Outcome measures

Measure

Single Hormone Closed Loop n=10 Participants 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

Mean Score of Visual Analog Scale at 120 Minutes

0.7 mm Standard Deviation 1.3

SECONDARY outcome

Timeframe: End of 10 hour study

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.

Outcome measures

Measure

Single Hormone Closed Loop n=10 Participants 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

Mean Score of Visual Analog Scale at End of Study

8.9 mm Standard Deviation 21.7

SECONDARY outcome

Timeframe: End of 10 hour study

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.

Outcome measures

Measure

Single Hormone Closed Loop n=10 Participants 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

Mean Draize Scale for Erythema for the Left Sensing Cannula at End of Study for All Subjects

0.2 units on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: end of 10 hour study

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.

Outcome measures

Measure

Single Hormone Closed Loop n=10 Participants 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

Mean Draize Scale for Edema for the Left Sensing Cannula at End of Study for All Subjects

0.15 units on a scale Standard Deviation 0.37

SECONDARY outcome

Timeframe: End of 10 hour study

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.

Outcome measures

Measure

Single Hormone Closed Loop n=10 Participants 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

Mean Draize Scale for Erythema for the Right Sensing Cannula at End of Study for All Subjects

0.2 units on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: end of 10 hour study

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.

Outcome measures

Measure

Single Hormone Closed Loop n=10 Participants 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

Mean Draize Scale for Edema for the Left Sensing Cannula at End of Study for All Subjects

0.2 units on a scale Standard Deviation 0.4

Adverse Events

Single Hormone Closed Loop

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure

Single Hormone Closed Loop n=10 participants at risk 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

Gastrointestinal disorders hospitalization for emesis

10.0% 1/10 • Number of events 1 • Up to 10 hours

Other adverse events

Adverse event data not reported

Additional Information

Jessica Castle MD

Oregon Health and Science University

Phone: 503-494-7072

Email: castleje@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place