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Blood glucose control systems that utilize both insulin and glucagon to manage blood sugar are paving the way to revolutionize the management of this disease. The benefit of improved control of blood sugar levels compared to standard insulin pump therapy has already been demonstrated. However, the risk of low blood sugar in type 1 diabetes increases considerably during exercise. The investigators research group has shown that small doses of glucagon can prevent low blood sugar when used in a blood sugar control system in patients with type 1 diabetes. However, as insulin sensitivity changes occur very rapidly during exercise, the ability to recognize the onset of physical activity in order to appropriately adjust the insulin and glucagon delivery is vital to helping prevent exercise-induced hypoglycemia.
The purpose of this study is to test how well a new modified blood sugar control system controls blood sugar during exercise compared to: 1) the current system without modifications and 2) standard insulin pump therapy.
Subjects will exercise during three study visits. During one visit, blood sugar will be controlled using standard insulin pump therapy. The investigators blood glucose control system will manage blood sugar for subjects during the other visits, with exercise announcement with insulin and glucagon delivery modifications during one visit. Treatment order will be randomized. Heart rate and accelerometry data will also be collected during each visit for the purposes of designing an exercise detection system for future studies.
Each subject will be asked to undergo an eligibility screening and to sign a consent form before any study procedures take place. At the screening appointment, after the consent form is signed, blood will be drawn for laboratory tests and a brief physical exam will be performed. An EKG and VO2max test will be completed at screening. Subjects that are enrolled in the study will come in for a sensor insertion visit up to 72 hours before each study visit. Subjects will undergo three 21-hour studies at an OHSU clinic or the OHSU clinical research center. Subjects will arrive at the research center at 8pm. Approximately 2 hours after a low-carbohydrate breakfast on Day 2, subjects will exercise for 45 minutes at 60% of their VO2max determined at screening. Three hours after completion of exercise, subjects will eat lunch. The study will end ~5 hours after lunch. Capillary blood glucose (CBG) will be measured every 2 hours during the day, every 3 hours at night and before and after exercise for studies using the blood glucose control system with subjects blinded to the CBG values. For studies using insulin pump therapy, the subject will sample CBG four times during the day as well as before and after exercise. Study staff will monitor studies remotely using a cloud server. An investigator or nurse practitioner with a specialty in endocrinology or internal medicine will be on site (located within the same complex) at all times.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Insulin Pump Therapy | Active Comparator | Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would. |
|
| Closed-loop without adjustment | Experimental | Subjects will undergo 21 study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made. |
|
| Closed-loop with adjustment | Experimental | Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin pump therapy | Device | Subject's own insulin pump will be used to manage blood glucose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Time With Sensed Glucose < 70 mg/dl | Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values less than 70 mg/dl using Dexcom sensor downloads. | from start of exercise (~hour 12) until study completion (hour 21) |
| Percent of Time With Sensed Glucose Between 70-180 mg/dl | Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values between 70-180 mg/dl using Dexcom sensor downloads. | from start of exercise (~hour 12) until study completion (hour 21) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean of the Mean Sensed Glucose Per Participant | Assess the mean sensed glucose per participant using Dexcom sensor downloads. | Entire 21 hour study duration excluding the first four hours |
| Number of Carbohydrate Treatments |
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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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | SAP, APN, APX (21 Hours) | The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), closed loop (APN) and closed loop with exercise announcement (APX). Each visit was 21 hours. |
| FG001 | SAP, APX, APN (21 Hours) | The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), closed loop with exercise announcement (APX), and closed loop (APN). Each visit was 21 hours. |
| FG002 | APN, SAP and APX (21 Hours) | The randomization order for subjects in this arm was closed loop (APN), open loop (Sensor Augmented Pump SAP), and closed loop with exercise announcement (APX). Each visit was 21 hours. |
| FG003 | APN, APX, SAP (21 Hours) | The randomization order for subjects in this arm was closed loop (APN), closed loop with exercise announcement (APX), and open loop (Sensor Augmented Pump SAP). Each visit was 21 hours. |
| FG004 | APX, SAP, APN (21 Hours) | The randomization order for subjects in this arm was closed loop with exercise announcement (APX), open loop (Sensor Augmented Pump SAP) and closed loop (APN). Each visit was 21 hours. |
| FG005 | APX, APN, SAP (21 Hours) | The randomization order for subjects in this arm was closed loop with exercise announcement (APX), closed loop (APN) and open loop (Sensor Augmented Pump SAP). Each visit was 21 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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 underwent three 21 hour study visits using either standard of care insulin pump therapy, closed loop control, or closed loop control with adjustments to insulin and glucagon after exercise announcement. Treatment order was randomized. |
| 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 | Percent of Time With Sensed Glucose < 70 mg/dl | Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values less than 70 mg/dl using Dexcom sensor downloads. | Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits. | Posted | Mean | 95% Confidence Interval | percentage of time | from start of exercise (~hour 12) until study completion (hour 21) |
|
9 months
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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 | Standard Insulin Pump Therapy | Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would. Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal 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 |
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| 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 |
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| Closed-loop Artificial Pancreas Controller | Device | 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. |
|
Assess the number of rescue carbohydrate treatments.
| Entire 21 hour study duration excluding the first four hours |
| Percent of Time With Sensed Glucose < 50 mg/dl | Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values less than 50 mg/dl using Dexcom sensor downloads. | Entire 21 hour study duration excluding the first four hours |
| Percent of Time With Sensed Glucose > 180 mg/dl | Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values greater than 180 mg/dl using Dexcom sensor downloads. | Entire 21 hour study duration excluding the first four hours |
| Number of Events Capillary Blood Glucose (CBG) <70 mg/dl | Number of events measured with capillary blood glucose <70 mg/dl. | Entire 21 hour study duration excluding the first four hours |
| Number of Events With CBG Between 70 - 180 mg/dl | Assess the number of events that the Contour Next BG meter reported blood glucose values between 70-180 mg/dl using meter downloads. | Entire 21 hour study duration excluding the first four hours |
| Number of Events With CBG <50 mg/dl | Assess the total number of events that the Contour Next BG meter reported blood glucose values less than 50 mg/dl across all participants in each group. | Entire 21 hour study duration excluding the first four hours |
| Percent of Time of CBG>180 mg/dl | Assess the percent of time that the Contour Next BG meter reported blood glucose values greater than 180 mg/dl using meter downloads. | Entire 21 hour study duration excluding the first four hours |
| Withdrawal by Subject |
|
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Closed-loop Without Adjustment |
Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made. Closed-loop Artificial Pancreas Controller: 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. |
| OG002 | Closed-loop With Adjustment | Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made. Closed-loop Artificial Pancreas Controller: 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. |
|
|
| Primary | Percent of Time With Sensed Glucose Between 70-180 mg/dl | Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values between 70-180 mg/dl using Dexcom sensor downloads. | Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits. | Posted | Mean | 95% Confidence Interval | percent of time | from start of exercise (~hour 12) until study completion (hour 21) |
|
|
|
| Secondary | Mean of the Mean Sensed Glucose Per Participant | Assess the mean sensed glucose per participant using Dexcom sensor downloads. | Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits. | Posted | Mean | 95% Confidence Interval | mg/dl | Entire 21 hour study duration excluding the first four hours |
|
|
|
| Secondary | Number of Carbohydrate Treatments | Assess the number of rescue carbohydrate treatments. | Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits. | Posted | Mean | 95% Confidence Interval | carbohydrate treatments | Entire 21 hour study duration excluding the first four hours |
|
|
|
| Secondary | Percent of Time With Sensed Glucose < 50 mg/dl | Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values less than 50 mg/dl using Dexcom sensor downloads. | Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits. | Posted | Mean | 95% Confidence Interval | percent of time | Entire 21 hour study duration excluding the first four hours |
|
|
|
| Secondary | Percent of Time With Sensed Glucose > 180 mg/dl | Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values greater than 180 mg/dl using Dexcom sensor downloads. | Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits. | Posted | Mean | 95% Confidence Interval | percent of time | Entire 21 hour study duration excluding the first four hours |
|
|
|
| Secondary | Number of Events Capillary Blood Glucose (CBG) <70 mg/dl | Number of events measured with capillary blood glucose <70 mg/dl. | Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits. | Posted | Mean | 95% Confidence Interval | occurrences of blood glucose < 70 mg/dl | Entire 21 hour study duration excluding the first four hours |
|
|
|
| Secondary | Number of Events With CBG Between 70 - 180 mg/dl | Assess the number of events that the Contour Next BG meter reported blood glucose values between 70-180 mg/dl using meter downloads. | Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits. | Posted | Mean | 95% Confidence Interval | # of events | Entire 21 hour study duration excluding the first four hours |
|
|
|
| Secondary | Number of Events With CBG <50 mg/dl | Assess the total number of events that the Contour Next BG meter reported blood glucose values less than 50 mg/dl across all participants in each group. | Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits. | Posted | Number | occurrences of blood glucose < 50 mg/dl | Entire 21 hour study duration excluding the first four hours |
|
|
|
| Secondary | Percent of Time of CBG>180 mg/dl | Assess the percent of time that the Contour Next BG meter reported blood glucose values greater than 180 mg/dl using meter downloads. | Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits. | Posted | Mean | 95% Confidence Interval | percentage of time | Entire 21 hour study duration excluding the first four hours |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 1 |
| 23 |
| EG001 | Closed-loop Without Adjustment | Subjects will undergo 21 study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made. Closed-loop Artificial Pancreas Controller: 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 | 23 | 0 | 23 | 3 | 23 |
| EG002 | Closed-loop With Adjustment | Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made. Closed-loop Artificial Pancreas Controller: 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 | 23 | 0 | 23 | 3 | 23 |
| mild edema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| chills | General disorders | Non-systematic Assessment |
|
| ligh headedness | Nervous system disorders | Non-systematic Assessment |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |