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Closed-loop systems are an emerging technology that automate hormone delivery. They are quickly paving the way to revolutionize the treatment of type 1 diabetes. Several categories have emerged: dual-hormone (insulin and glucagon) closed-loop systems and closed-loop systems with insulin only, one variety of which is the low glucose suspend safety feature now available from Medtronic (MiniMed 530G with Enlite). The study described within this protocol is designed to test the efficacy of a new closed-loop algorithm for managing blood glucose in people with type 1 diabetes before and after exercise. The new algorithm will have 3 modes: a single hormone insulin only mode, a dual-hormone insulin and glucagon mode and an insulin only mode with predictive low glucose suspend, all with an exercise detection algorithm. The purpose of this study is to determine whether a dual hormone AP with an exercise detection algorithm outperforms both single hormone AP and a low glucose suspend algorithm and sensor augmented pump therapy using the subject's own insulin pump.
Subjects will undergo four approximately 84 hour studies. The first day of each study will be an approximately 12 hour inpatient visit to include activities of daily living and an exercise period with 2 days spent as an outpatient. The subject will come back to the research center on the fourth day to complete another approximately 12 hour inpatient visit to include activities of daily living and an exercise period followed by removal of all devices. In randomized order, subjects will have glucose controlled using the following systems: 1) dual-hormone closed-loop system, 2) insulin only closed-loop system, 3) predictive low glucose suspend system and 4) sensor augmented pump therapy with subject using their own insulin and insulin pump. Both of the closed-loop system algorithms have an exercise detection algorithm that uses inputs from a heart rate monitor and accelerometer, the Zephyrlife BioPatch. After exercise detection, insulin is turned off for the first 30 minutes, the total insulin infusion rate is adjusted by an exercise multiplier, and for the dual-hormone system, the target glucose for glucagon is increased along with the maximum dose of glucagon allowed. The predictive low glucose suspend system will utilize the patient's optimized basal rates, correction factor, and carb ratio. The patient will bolus for meals and hyperglycemia as usual under PLGS, but will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event. The Dexcom CGM system and the Tandem t:slim pumps will be used for all three intervention visits.
Subjects will arrive at the CTRC at 7am at the start of intervention visits. Subjects will eat breakfast, lunch and dinner in the research center. Subjects will eat breakfast at 8:30am. After breakfast, subjects will complete activities of daily living (sitting on a chair, lying on a bed, washing dishes, sweeping the floor, etc.). Subjects will eat lunch at 12pm. Subjects will exercise for 45 minutes on a treadmill around 2pm. Subjects will eat dinner at 6pm and be discharged. The subject will then go home for Day 2 and Day 3 and return on Day 4 to complete another 12 hour inpatient visit with the schedule of activities identical to Day 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Predictive Low Glucose Suspend Arm | Experimental | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient. The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient's optimized basal rates, correction factor, and carb ratio, but it will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event. |
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| Dual Hormone Closed-loop Arm | Experimental | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient using the closed-loop artificial pancreas controller in dual hormone mode to manage blood sugar that includes an exercise detection component that includes a reduction in insulin delivery and an increase in glucagon delivery upon detection. |
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| Single Hormone Closed-loop Arm | Experimental | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient using the closed-loop artificial pancreas controller in single hormone mode to manage blood sugar that includes an exercise detection component that includes a reduction in insulin delivery upon detection. |
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| Sensor Augmented Pump Therapy arm | Active Comparator | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Pancreas Controller in Dual Hormone Mode | Device | The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Time With Sensed Glucose < 3.9 mmol/L | Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms. | entire 84 hour study |
| Percent of Time With Sensed Glucose < 3.9 mmol/L | Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms. | From 14:00-18:00 for each 12 hour inpatient visit |
| Percent of Time With Sensed Glucose Between 3.9-10 mmol/L | Assess the percent of time that the Dexcom G4 Share reported sensor glucose values between 3.9-10 mmol/L using Dexcom sensor downloads across all four arms. | entire 84 hour study |
| Percent of Time With Sensed Glucose Between 3.9-10 mmol/L | Assess the percent of time that the Dexcom G4 Share reported sensor glucose values between 3.9-10 mmol/L using Dexcom sensor downloads across all four arms. | From 14:00-18:00 for each 12 hour inpatient visit |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Sensed Glucose | Assess the mean sensor glucose using Dexcom sensor downloads across all four arms. | entire 84 hour study |
| Number of Carbohydrate Treatments | Assess the number of rescue carbohydrate treatments per day across all four arms. |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29752345 | Derived | Castle JR, El Youssef J, Wilson LM, Reddy R, Resalat N, Branigan D, Ramsey K, Leitschuh J, Rajhbeharrysingh U, Senf B, Sugerman SM, Gabo V, Jacobs PG. Randomized Outpatient Trial of Single- and Dual-Hormone Closed-Loop Systems That Adapt to Exercise Using Wearable Sensors. Diabetes Care. 2018 Jul;41(7):1471-1477. doi: 10.2337/dc18-0228. Epub 2018 May 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SAP, PLGS, DH, SH | The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), predictive low glucose suspend (PLGS), dual hormone (DH) and single hormone (SH). Each visit was 84 hours and included inpatient and outpatient portions. |
| FG001 | SAP, DH, SH, PLGS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Tslim Training Visit (2 Weeks) |
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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 | Feb 1, 2017 |
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| Subject's insulin pump | Device | Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would. |
|
| Artificial Pancreas Controller in Single Hormone Mode | Device | The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin. |
|
| Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode | Device | The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin. |
|
| entire 84 hour study |
| Percent of Time With Sensed Glucose < 3.0 mmol/L | Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.0 mmol/L using Dexcom sensor downloads across all four arms. | entire 84 hour study |
| Percent of Time With Sensed Glucose > 10 mmol/L | Assess the percent of time that the Dexcom G4 Share reported sensor glucose values greater than 10 mmol/L using Dexcom sensor downloads across all four arms | entire 84 hour study |
| Number of Events With Capillary Blood Glucose < 3.9 mmol/L | Assess number of events with capillary blood glucose < 3.9 mmol/L using downloads from a Contour Next blood glucose meter across all four arms. . | entire 84 hour study |
| Number of Events With Capillary Blood Glucose < 3.0 mmol/L | Assess number of events with capillary blood glucose < 3.0 mmol/L using downloads from a Contour Next blood glucose meter across all four arms. | entire 84 hour study |
| Mean Amount of Insulin Delivered | Assess the average amount of insulin delivered per day in units/kg as documented through the artificial pancreas controller across all four arms. | 24 hours |
| Mean Amount of Glucagon Delivered | Assess the average amount of insulin delivered per day in units/kg as documented through the artificial pancreas controller in dual hormone arm. | 24 hours |
The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), dual hormone (DH), single hormone (SH) and predictive low glucose suspend (PLGS). Each visit was 84 hours and included inpatient and outpatient portions. |
| FG002 | DH, SH, SAP, PLGS | The randomization order for subjects in this arm was dual hormone (DH), single hormone (SH), open loop (Sensor Augmented Pump SAP), and predictive low glucose suspend (PLGS). Each visit was 84 hours and included inpatient and outpatient portions. |
| FG003 | SH, SAP, PLGS, DH | The randomization order for subjects in this arm was single hormone (SH), open loop (Sensor Augmented Pump SAP), predictive low glucose suspend (PLGS) and dual hormone (DH). Each visit was 84 hours and included inpatient and outpatient portions. |
| FG004 | PLGS, DH, SH, SAP | The randomization order for subjects in this arm was predictive low glucose suspend (PLGS), dual hormone (DH), single hormone (SH), and open loop (Sensor Augmented Pump SAP). Each visit was 84 hours and included inpatient and outpatient portions. |
| FG005 | PLGS, SAP, SH, DH | The randomization order for subjects in this arm was predictive low glucose suspend (PLGS), open loop (Sensor Augmented Pump SAP), single hormone (SH), and dual hormone (DH). Each visit was 84 hours and included inpatient and outpatient portions. |
| FG006 | SAP, DH, PLGS, SH | The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), dual hormone (DH), predictive low glucose suspend (PLGS), and single hormone (SH). Each visit was 84 hours and included inpatient and outpatient portions. |
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| NOT COMPLETED |
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| First Rest Period (1-12 Weeks) |
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| First Intervention (84 Hours) |
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| Second Rest Period (7-45 Days) |
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| Second Intervention (84 Hours) |
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| Third Rest Period (7-45 Days) |
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| Third Intervention (84 Hours) |
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| Fourth Rest Period (7-45 Days) |
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| Fourth Intervention (84 Hours) |
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Type 1 diabetics using an insulin pump
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants were randomized to complete four 84 hour study visits using either standard of care insulin pump therapy, dual hormone, single hormone or predictive low glucose suspend closed loop control. Treatment order was randomized. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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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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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Percent of Time With Sensed Glucose < 3.9 mmol/L | Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms. | All subjects analyzed for those who started a PLGS, SH, DH or SAP arm. | Posted | Mean | Standard Deviation | percentage of 84 hours | entire 84 hour study |
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| ||||||||||||||||||||||||||||||||||
| Primary | Percent of Time With Sensed Glucose < 3.9 mmol/L | Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms. | All subjects analyzed for those who started a PLGS, SH, DH or SAP arm. | Posted | Mean | Standard Deviation | percentage of 4 hours after exercise | From 14:00-18:00 for each 12 hour inpatient visit |
| ||||||||||||||||||||||||||||||||||||
| Primary | Percent of Time With Sensed Glucose Between 3.9-10 mmol/L | Assess the percent of time that the Dexcom G4 Share reported sensor glucose values between 3.9-10 mmol/L using Dexcom sensor downloads across all four arms. | All subjects analyzed for those who started a PLGS, SH, DH or SAP arm. | Posted | Mean | Standard Deviation | percentage of 84 hours | entire 84 hour study |
| ||||||||||||||||||||||||||||||||||||
| Primary | Percent of Time With Sensed Glucose Between 3.9-10 mmol/L | Assess the percent of time that the Dexcom G4 Share reported sensor glucose values between 3.9-10 mmol/L using Dexcom sensor downloads across all four arms. | All subjects analyzed for those who started a PLGS, SH, DH or SAP arm. | Posted | Mean | Standard Deviation | percentage of 4 hours after exercise | From 14:00-18:00 for each 12 hour inpatient visit |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean Sensed Glucose | Assess the mean sensor glucose using Dexcom sensor downloads across all four arms. | All subjects analyzed for those who started a PLGS, SH, DH or SAP arm. | Posted | Mean | Standard Deviation | mg/dL | entire 84 hour study |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Carbohydrate Treatments | Assess the number of rescue carbohydrate treatments per day across all four arms. | All subjects analyzed for those who started a PLGS, SH, DH or SAP arm. | Posted | Mean | Standard Deviation | number of carbohydrate treatments/day | entire 84 hour study |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Time With Sensed Glucose < 3.0 mmol/L | Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.0 mmol/L using Dexcom sensor downloads across all four arms. | All subjects analyzed for those who started a PLGS, SH, DH or SAP arm. | Posted | Mean | Standard Deviation | percentage of 84 hours | entire 84 hour study |
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| Secondary | Percent of Time With Sensed Glucose > 10 mmol/L | Assess the percent of time that the Dexcom G4 Share reported sensor glucose values greater than 10 mmol/L using Dexcom sensor downloads across all four arms | All subjects analyzed for those who started a PLGS, SH, DH or SAP arm. | Posted | Mean | Standard Deviation | percentage of 84 hours | entire 84 hour study |
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| Secondary | Number of Events With Capillary Blood Glucose < 3.9 mmol/L | Assess number of events with capillary blood glucose < 3.9 mmol/L using downloads from a Contour Next blood glucose meter across all four arms. . | All subjects analyzed for those who started a PLGS, SH, DH or SAP arm. | Posted | Mean | Standard Deviation | number of events | entire 84 hour study |
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| Secondary | Number of Events With Capillary Blood Glucose < 3.0 mmol/L | Assess number of events with capillary blood glucose < 3.0 mmol/L using downloads from a Contour Next blood glucose meter across all four arms. | All subjects analyzed for those who started a PLGS, SH, DH or SAP arm. | Posted | Mean | Standard Deviation | number of events | entire 84 hour study |
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| Secondary | Mean Amount of Insulin Delivered | Assess the average amount of insulin delivered per day in units/kg as documented through the artificial pancreas controller across all four arms. | All subjects analyzed for those who started a PLGS, SH, DH or SAP arm. | Posted | Mean | Standard Deviation | units/kg | 24 hours |
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| Secondary | Mean Amount of Glucagon Delivered | Assess the average amount of insulin delivered per day in units/kg as documented through the artificial pancreas controller in dual hormone arm. | All subjects analyzed for those who started a PLGS, SH, DH or SAP arm. | Posted | Mean | Standard Deviation | mcg/kg | 24 hours |
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12 months
All participants that began/started the tslim training visit or a PLGS, SH, DH or SAP arm are included in the adverse events. The numbers from the participant flow indicate 25 subjects began the tslim training visit, 23 subjects began a PLGS visit, and 22 subjects began a DH, SH or SAP visit.
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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 | Predictive Low Glucose Suspend Arm | Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin. | 0 | 23 | 0 | 23 | 5 | 23 |
| EG001 | Dual Hormone Closed-loop Arm | Artificial Pancreas Controller in Dual Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon. | 0 | 22 | 0 | 22 | 8 | 22 |
| EG002 | Single Hormone Closed-loop Arm | Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin. | 0 | 22 | 0 | 22 | 2 | 22 |
| EG003 | Sensor Augmented Pump Therapy Arm | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone. Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would. | 0 | 22 | 0 | 22 | 3 | 22 |
| EG004 | Tslim Training | Subjects used the tslim and Dexcom G4 Share of G5 sensor for two weeks at home to allow subjects to become familiar with the devices. | 0 | 25 | 0 | 25 | 2 | 25 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI upset | Gastrointestinal disorders | Non-systematic Assessment | GI upset includes: nausea, stomach cramps, belching, sour stomach. |
| |
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| mild edema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | minor pain and redness at IV or infusion site |
| |
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Rash at a sensor insertion site or from heart rate monitor. |
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| Hyperglycemia | Endocrine disorders | Non-systematic Assessment |
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| Sore throat | Gastrointestinal disorders | Non-systematic Assessment |
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| device induced symptomatic hypoglycemia | Endocrine disorders | Non-systematic Assessment |
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| Lightheadedness | Nervous system disorders | Non-systematic Assessment |
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| Presyncope | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Castle | Oregon Health and Science University | 503-494-7072 | castleje@ohsu.edu |
| Apr 5, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
Not provided
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| Unknown or Not Reported |
|
| OG002 | Single Hormone Closed-loop Arm | Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin. |
| OG003 | Sensor Augmented Pump Therapy Arm | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone. Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would. |
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| OG002 | Single Hormone Closed-loop Arm | Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin. |
| OG003 | Sensor Augmented Pump Therapy Arm | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone. Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would. |
|
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| OG002 | Single Hormone Closed-loop Arm | Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin. |
| OG003 | Sensor Augmented Pump Therapy Arm | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone. Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would. |
|
|
| OG002 | Single Hormone Closed-loop Arm | Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin. |
| OG003 | Sensor Augmented Pump Therapy Arm | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone. Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would. |
|
|
| OG002 | Single Hormone Closed-loop Arm | Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin. |
| OG003 | Sensor Augmented Pump Therapy Arm | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone. Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would. |
|
|
| OG002 | Single Hormone Closed-loop Arm | Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin. |
| OG003 | Sensor Augmented Pump Therapy Arm | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone. Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would. |
|
|
| OG002 | Single Hormone Closed-loop Arm | Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin. |
| OG003 | Sensor Augmented Pump Therapy Arm | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone. Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would. |
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| OG002 | Single Hormone Closed-loop Arm | Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin. |
| OG003 | Sensor Augmented Pump Therapy Arm | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone. Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would. |
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| OG002 | Single Hormone Closed-loop Arm | Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin. |
| OG003 | Sensor Augmented Pump Therapy Arm | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone. Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would. |
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| OG002 | Single Hormone Closed-loop Arm | Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin. |
| OG003 | Sensor Augmented Pump Therapy Arm | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone. Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would. |
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| OG002 | Single Hormone Closed-loop Arm | Artificial Pancreas Controller in Single Hormone Mode: The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin. |
| OG003 | Sensor Augmented Pump Therapy Arm | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone. Subject's insulin pump: Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would. |
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