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The study described within this protocol is designed to test a single hormone closed-loop algorithm for managing blood glucose in type 1 diabetes using insulin only and a new device for measuring glucose continuously in the immediate vicinity of subcutaneous insulin delivery. Subjects will undergo one all day closed loop study using insulin only. The closed loop insulin only system includes a Dexcom G5 transmitter, a Nexus 5 smart phone and two Tandem tslim pumps connected to two Pacific Diabetes Technologies glucose sensing cannulas. The closed loop system will be started after G5 2 hour sensor start-up with an IV catheter for frequent blood withdrawal for 10 hours.
Subjects will undergo one 12 hour inpatient study. During this intervention visit, subjects will wear the single hormone closed loop system which includes two t:slim insulin pumps to deliver insulin or saline through two investigational PDT glucose sensing cannulas, and a Dexcom G5 CGM to measure glucose. The subject will come to the research center at approximately 7am for the inpatient visit. The Dexcom G5 sensor and PDT glucose sensing cannulas will be placed after arrival. An 18-22 gauge IV catheter will be placed for blood sampling every 15 minutes after sensor warm-up is complete for measuring blood glucose concentration. After a 2 hour warm-up period for the G5 sensor, glucose will be controlled using the FMPD single hormone mode. The single hormone mode of the controller determines insulin delivery rates based on proportional and derivative error through one t:slim insulin pump. The second t:slim insulin pump will deliver normal saline at the same delivery rates as the insulin. Subjects will eat breakfast and lunch at approximately 11 am and 3 pm respectively. Subjects will have the ability to complete light exercise on a treadmill. The closed loop system will be stopped at approximately 6pm with removal of all devices.
During the study, the subject will wear one subcutaneous DexcomTM G5 continuous glucose monitoring (CGM) system. The CGM system will provide sensed glucose data every 5 minutes. The accuracy of the sensed data will be obtained by reference measurements of two YSI venous blood glucose values to calibrate the sensor at the beginning of the closed loop study. Sensed glucose data will be wirelessly transmitted via Bluetooth Low Energy (BTLE) from the Dexcom G5 transmitter to the Nexus 5 master controller every five minutes. The controller is a Google Nexus 5 phone. The smart phone will wirelessly communicate via BTLE to two Tandem t:slim insulin pumps, one for automated insulin delivery and one of automated saline delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Hormone closed loop | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Pancreas Control system (APC) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Absolute Relative Difference of Sensed Glucose Values | Assess the mean absolute relative difference for the PDT CGM/insulin infusion system based on all reference YSI venous blood glucose values. | up to 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Time With Sensed Glucose Between 70-180 mg/dl | Assess the percent of time with sensed glucose between 70-180 mg/dl based on the Dexcom G5 CGM sensor values for all subjects. | up to 10 hours |
| Percent of Time With Sensed Glucose Less Than 70 mg/dl |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Castle, MD | Oregon Health and Science University | Principal Investigator |
| Peter Jacobs, PhD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Absolute Relative Difference of Sensed Glucose Values | Assess the mean absolute relative difference for the PDT CGM/insulin infusion system based on all reference YSI venous blood glucose values. | Posted | Mean | Standard Deviation | percentage of reference blood glucose | up to 10 hours |
|
Up to 10 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization for emesis | Gastrointestinal disorders | Non-systematic Assessment | Hospitalization for persistant emesis and nausea |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Castle MD | Oregon Health and Science University | 503-494-7072 | castleje@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2019 | Jul 29, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Pacific Diabetes Technologies CGM Insulin Infusion system | Device | An integrated combination CGM/insulin infusion system |
|
Assess the percent of time with sensed glucose less than 70 mg/dl based on the Dexcom G5 CGM sensor values for all subjects. |
| up to 10 hours |
| Percent of Time With Sensed Glucose Less Than 54 mg/dl | Assess the percent of time with sensed glucose less than 54 mg/dl based on the Dexcom G5 CGM sensor values for all subjects. | up to 10 hours |
| Percent of Time With Sensed Glucose Greater Than 250 mg/dl | Assess the percent of time with sensed glucose greater than 250 mg/dl based on the Dexcom G5 CGM sensor values for all subjects. | up to 10 hours |
| Mean Sensed Glucose | Assess the average sensor glucose based on the Dexcom G5 CGM sensor values. | up to 10 hours |
| Number of Carbohydrate Treatments | Assess the average number of carbohydrate treatments per study defined as 15 or 20 grams of carbohydrates. | up to 10 hours |
| Mean Amount of Insulin Delivered | Assess the average amount of insulin delivered per study in units/kg. | up to 10 hours |
| Mean Score of Visual Analog Scale at 15 Minutes | 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. | 15 minutes post insertion |
| Mean Score of Visual Analog Scale at 120 Minutes | 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. | 120 minutes post insertion |
| Mean Score of Visual Analog Scale at End of 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. | End of 10 hour study |
| Mean Draize Scale for Erythema for the Left Sensing Cannula at End of Study for All Subjects | 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. | End of 10 hour study |
| Mean Draize Scale for Edema for the Left Sensing Cannula at End of Study for All Subjects | 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. | end of 10 hour study |
| Mean Draize Scale for Erythema for the Right Sensing Cannula at End of Study for All Subjects | 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. | End of 10 hour study |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Percent of Time With Sensed Glucose Between 70-180 mg/dl | Assess the percent of time with sensed glucose between 70-180 mg/dl based on the Dexcom G5 CGM sensor values for all subjects. | Posted | Mean | Standard Deviation | percentage of time | up to 10 hours |
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| Secondary | Percent of Time With Sensed Glucose Less Than 70 mg/dl | Assess the percent of time with sensed glucose less than 70 mg/dl based on the Dexcom G5 CGM sensor values for all subjects. | Posted | Mean | Standard Deviation | percentage of time | up to 10 hours |
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| Secondary | Percent of Time With Sensed Glucose Less Than 54 mg/dl | Assess the percent of time with sensed glucose less than 54 mg/dl based on the Dexcom G5 CGM sensor values for all subjects. | Posted | Mean | Standard Deviation | percentage of time | up to 10 hours |
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| Secondary | Percent of Time With Sensed Glucose Greater Than 250 mg/dl | Assess the percent of time with sensed glucose greater than 250 mg/dl based on the Dexcom G5 CGM sensor values for all subjects. | Posted | Mean | Standard Deviation | percentage of time | up to 10 hours |
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| Secondary | Mean Sensed Glucose | Assess the average sensor glucose based on the Dexcom G5 CGM sensor values. | Posted | Mean | Standard Deviation | mg/dL | up to 10 hours |
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| Secondary | Number of Carbohydrate Treatments | Assess the average number of carbohydrate treatments per study defined as 15 or 20 grams of carbohydrates. | Posted | Mean | Standard Deviation | carbohydrate treatments | up to 10 hours |
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| Secondary | Mean Amount of Insulin Delivered | Assess the average amount of insulin delivered per study in units/kg. | Posted | Mean | Standard Deviation | units/kg | up to 10 hours |
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| Secondary | Mean Score of Visual Analog Scale at 15 Minutes | 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. | Posted | Mean | Standard Deviation | mm | 15 minutes post insertion |
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| Secondary | Mean Score of Visual Analog Scale at 120 Minutes | 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. | Posted | Mean | Standard Deviation | mm | 120 minutes post insertion |
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| Secondary | Mean Score of Visual Analog Scale at End of 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. | Posted | Mean | Standard Deviation | mm | End of 10 hour study |
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| Secondary | Mean Draize Scale for Erythema for the Left Sensing Cannula at End of Study for All Subjects | 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. | Posted | Mean | Standard Deviation | units on a scale | End of 10 hour study |
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| Secondary | Mean Draize Scale for Edema for the Left Sensing Cannula at End of Study for All Subjects | 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. | Posted | Mean | Standard Deviation | units on a scale | end of 10 hour study |
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| Secondary | Mean Draize Scale for Erythema for the Right Sensing Cannula at End of Study for All Subjects | 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. | Posted | Mean | Standard Deviation | units on a scale | End of 10 hour study |
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| Secondary | Mean Draize Scale for Edema for the Left Sensing Cannula at End of Study for All Subjects | 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. | Posted | Mean | Standard Deviation | units on a scale | end of 10 hour study |
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| 0 |
| 10 |
| 1 |
| 10 |
| 0 |
| 10 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |