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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DK129382-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to test how well a new investigational closed loop system manages your blood sugar with the ability to deliver insulin and pramlintide. Pramlintide is a drug that is used with mealtime insulin to control blood sugar in people who have diabetes. It works by slowing down the movement of food through the stomach which prevents blood sugar from rising too high after a meal. The closed loop system will receive glucose values from the Dexcom G6 continuous glucose monitoring (CGM) and automatically send commands to one Omnipod for insulin and one Omnipod for pramlintide delivery.
Participants will undergo two 12.5 hour clinic visits. Participants will complete a training on how to start the Dexcom G6 sensor at home. Participants will start the G6 sensor the day before each study visit. For one visit, the system will use insulin only for managing blood sugar. For the other study, the system will use both insulin and pramlintide. The order of the visits will be randomly chosen. For 3 days before the insulin and pramlintide visit, participants will dose with pramlintide before each meal. During the visits, participants will wear one or two Omnipods to delivery insulin and insulin/pramlintide and a Dexcom G6 CGM. The CGM system will provide sensor glucose data every 5 minutes. Sensor glucose data will be wirelessly transmitted via Bluetooth Low Energy (BTLE) from the Dexcom G6 to the smartphone master controller every 5 minutes. The smartphone will communicate via BTLE to an Omnipod for insulin delivery. The closed loop system will receive activity data through a Polar M600 watch worn by the participant. Participants will eat breakfast and lunch in clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Only Arm | Experimental | Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic. |
|
| Insulin and Pramlintide Arm | Experimental | Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MPC closed-loop system in insulin only mode | Device | The Model Predictive Control (MPC) insulin infusion algorithm contains a model within the controller that takes as an input the aerobic metabolic expenditure in addition to the CGM and meal in puts. The algorithm uses heart rate and accelerometer data collected on the patient's body to calculate metabolic expenditure (METs). The METs then acts on the model for the insulin dynamics, whereby more energy expenditure and longer duration exercise can lead to a more substantial effect of insulin on the CGM. The MPC also has missed meal insulin bolus detection where the system will calculate the amount of insulin that was missed for a meal. The missed meal boluses can be delivered automatically without any input from the user. This feature can also be disabled. The device in this mode will administer insulin continuously for managing blood sugar. |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental Area Under the Curve of Postprandial Glucose Following the First Meal | Incremental area under the curve (iAUC) of postprandial glucose (mg/dL*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose for the obseration period. Values shown are (mg/dL*min)/1000. | 6 hours following first meal |
| Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following First Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator. | 6 hours following first meal |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental Area Under the Curve of Postprandial Glucose Following the Second Meal | Incremental area under the curve (iAUC) of postprandial glucose (mg/dL*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose for the obseration period. Values shown are iAUC/1000. | 6 hours following second meal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leah Wilson, 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 |
Participants were randomized immediately after screening.
A total of 35 people (19 females and 16 males) with type 1 diabetes mellitus have completed screening visits for the study from July-December 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Only Arm | Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic. |
| FG001 | Insulin and Pramlintide Arm | Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin-only to Insulin+Pramlintide | Participants will use the closed loop system with insulin-only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Then they will return after washout period to use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. For both arms, sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic. |
| 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, Continuous | A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up. |
| 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 | Incremental Area Under the Curve of Postprandial Glucose Following the First Meal | Incremental area under the curve (iAUC) of postprandial glucose (mg/dL*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose for the obseration period. Values shown are (mg/dL*min)/1000. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Mean | Standard Deviation | (mg/dl*min)/1000 | 6 hours following first meal |
|
Up to seven weeks from study enrollment to study completion. This includes two clinic visits and time in between.
All the participants that started the first treatment period after randomization are included in the adverse events.
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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 | Insulin Only Arm | Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leah Wilson | Oregon Health & Science University | 5034943273 | wilsolea@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: Study Protocol | Oct 30, 2024 | Dec 31, 2025 | Prot_SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol: Study Protocol 1 | Oct 30, 2024 | Dec 31, 2025 | Prot_001.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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|
| MPC closed-loop system in insulin/pramlintide mode | Device | The Model Predictive Control (MPC) insulin infusion algorithm contains a model within the controller that takes as an input the aerobic metabolic expenditure in addition to the CGM and meal in puts. The algorithm uses heart rate and accelerometer data collected on the patient's body to calculate metabolic expenditure (METs). The METs then acts on the model for the insulin dynamics, whereby more energy expenditure and longer duration exercise can lead to a more substantial effect of insulin on the CGM. The MPC also has missed meal insulin bolus detection where the system will calculate the amount of insulin that was missed for a meal. The missed meal boluses can be delivered automatically without any input from the user. This feature can also be disabled. The device in this mode will administer both insulin and pramlintide continuously for managing blood sugar. The system will deliver pramlintide in a fixed ratio to insulin at 6 mcg of pramlintide delivered for every 1 unit of insulin. |
|
| Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following Second Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator. | 6 hours following second meal |
| Net Area Under the Curve of Postprandial Glucose Following the First Meal | Net area under the curve (netAUC) of postprandial glucose (mg/dL*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose and subtracts CGM values below the starting glucose for the observation period. Values shown are (mg/dL*min)/1000. | 6 hours following first meal |
| Net Area Under the Curve of Postprandial Glucose Following the Second Meal | Net area under the curve (netAUC) of postprandial glucose (mg/dL*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose and subtracts CGM values below the starting glucose for the observation period. Values shown are (mg/dl *min)/1000 | 6 hours following second meal |
| Net Area Under the Curve of Postprandial Glucose | Net area under the curve (netAUC) of postprandial glucose (mg/dL*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose and subtracts CGM values below the starting glucose for the observation period. Values shown are (mg/dL*min)/1000. | 12 hour clinic visit |
| Percent of Time With Sensed Glucose <70 mg/dL Following First Meal | Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor in the 6 hours following the start of the first meal. Because so few participants had any sensed glucose values <70 mg/dL, this summary shows the count of participants with any time (>0) with sensed glucose <70 mg/dL | 6 hours following first meal |
| Percent of Time With Sensed Glucose <70 mg/dL Following Second Meal | Because so few participants had any sensed glucose values <70 mg/dL, this summary shows the count of participants with any time (>0) with sensed glucose <70 mg/dL | 6 hours following second meal |
| Percent of Time With Sensed Glucose <70 mg/dL | Because so few participants had any sensed glucose values <70 mg/dL, this summary shows the count of participants with any time (>0) with sensed glucose <70 mg/dL | 12 hour clinic visit |
| Percent of Time With Sensed Glucose Between 70-140 mg/dL Following First Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator. | 6 hours following first meal |
| Percent of Time With Sensed Glucose Between 70-140 mg/dL Following Second Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator. | 6 hours following second meal |
| Percent of Time With Sensed Glucose Between 70-140 mg/dL | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the twelve hours of the clinic visit as the denominator. | 12 hour clinic visit |
| Mean Sensed Glucose Following First Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The outcome is calculated as the average of these values for the six hours following the meal. | 6 hours following first meal |
| Mean Sensed Glucose Following Second Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The outcome is calculated as the average of these values for the six hours following the meal. | 6 hours following second meal |
| Mean Sensed Glucose | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The outcome is calculated as the average of these values for the twelve-hour clinic visit. | 12 hour clinic visit |
| Percent of Time With Sensed Glucose <54 mg/dL Following First Meal | Because so few participants had any sensed glucose values <54 mg/dL, this summary shows the count of participants with any time (>0) with sensed glucose <54 mg/dL | 6 hours following first meal |
| Percent of Time With Sensed Glucose <54 mg/dL Following Second Meal | Because so few participants had any sensed glucose values <54 mg/dL, this summary shows the count of participants with any time (>0) with sensed glucose <54 mg/dL | 6 hours following second meal |
| Percent of Time With Sensed Glucose <54 mg/dL | Because so few participants had any sensed glucose values <54 mg/dL, this summary shows the count of participants with any time (>0) with sensed glucose <54 mg/dL. | 12 hour clinic visit |
| Percent of Time With Sensed Glucose >180 mg/dL Following First Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator. | 6 hours following first meal |
| Percent of Time With Sensed Glucose >180 mg/dL Following Second Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator. | 6 hours following second meal |
| Percent of Time With Sensed Glucose >180 mg/dL | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the twelve-hour clinic visit as the denominator. | 12 hour clinic visit |
| Percent of Time With Sensed Glucose >250 mg/dL Following First Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours after the meal as the denominator. | 6 hours following first meal |
| Percent of Time With Sensed Glucose >250 mg/dL Following Second Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours after the meal as the denominator. | 6 hours following second meal |
| Percent of Time With Sensed Glucose >250 mg/dL | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the twelve hours of the clinic visit as the denominator. | 12 hour clinic visit |
| Median Amount of Insulin Delivered Following First Meal | Amount of insulin (units) delivered in the 6 hours following the first meal. | 6 hours following the first meal |
| Median Amount of Insulin Delivered Following Second Meal | Amount of insulin (units) delivered. in the 6 hours following the second meal. | 6 hours following the second meal |
| Median Amount of Insulin Delivered | Amount of insulin (units) delivered | 12 hour clinic visit |
| Median Amount of Pramlintide Delivered Following First Meal | Amount of pramlintide (mcg) delivered in the 6 hours following the first meal. | 6 hours following the first meal |
| Median Amount of Pramlintide Delivered Following Second Meal | Amount of pramlintide (mcg) delivered in the 6 hours following the second meal. | 6 hours following the second meal |
| Median Amount of Pramlintide Delivered | Amount of pramlintide (mcg) delivered | 12 hour clinic visit |
| Coefficient of Variation Following First Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The coefficient of variation outcome is calculated as (100 * [standard deviation] / mean) of these values for the six hours following the meal. | 6 hours following the first meal |
| Coefficient of Variation Following Second Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The coefficient of variation outcome is calculated as (100 * [standard deviation] / mean) of these values for the six hours following the meal. | 6 hours following the second meal |
| Coefficient of Variation | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The coefficient of variation outcome is calculated as (100 * [standard deviation] / mean) of these values for the twelve hours in the clinic. | 12 hour clinic visit |
| Low Blood Glucose Index (LBGI) Following the First Meal | The Low Blood Glucose Index (LBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138 | 6 hours following the first meal |
| Low Blood Glucose Index (LBGI) Following the Second Meal | The Low Blood Glucose Index (LBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138 | 6 hours following the second meal |
| Low Blood Glucose Index (LBGI) | The Low Blood Glucose Index (LBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138 | 12 hour clinic visit |
| High Blood Glucose Index (HBGI) Following the First Meal | The High Blood Glucose Index (HBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138 | 6 hours following the first meal |
| High Blood Glucose Index (HBGI) Following the Second Meal | The High Blood Glucose Index (HBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138 | 6 hours following the second meal |
| High Blood Glucose Index (HBGI) | The High Blood Glucose Index (HBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138 | 12 hour clinic visit |
| Adverse Events Related to Pramlintide | Assess the number of adverse events probably or possibly associated with pramlintide administration. | 4 days of pramlintide use |
| Baxter Retching Faces (BARF) Visual Analog Scale for Gastrointestinal Issues After the First Meal | Six hours after the meal, participants were asked to use the Baxter Retching Faces (BARF) visual analog scale to indicate the worst nausea/vomiting discomfort they felt over the prior 6 hours. The scale ranges from 0 (none) to 10 (most discomfort). | 6 hours following first meal |
| Baxter Retching Faces (BARF) Visual Analog Scale for Gastrointestinal Issues After the Second Meal | Six hours after the meal, participants were asked to use the Baxter Retching Faces (BARF) visual analog scale to indicate the worst nausea/vomiting discomfort they felt over the prior 6 hours. The scale ranges from 0 (none) to 10 (most discomfort). | 6 hours following second meal |
| Mean Duration of Gastrointestinal Issues After the First Meal | Six hours after the meal, participants were asked to report the approximate number of minutes they felt nausea during the prior 6 hours. | 6 hours following first meal |
| Mean Duration of Gastrointestinal Issues After the Second Meal | Six hours after the meal, participants were asked to report the approximate number of minutes they felt nausea during the prior 6 hours. | 6 hours following second meal |
| Episodes of Hypoglycemia | Counts of the number of episodes when the continuous glucose monitoring (CGM) values were <70 mg/dL for 10 minutes or more. | 12 hour clinic visit |
| Episodes of Carbohydrate Intake to Treat Hypoglycemia | Assess the number of rescue carbohydrate treatments (defined as 15 grams of carbohydrate intake) needed to treat hypoglycemia. | 12 hour clinic visit |
| Number of Provider-administered Insulin Injections | Assess the number of provider-administered insulin injections due to hyperglycemia. | 12 hour clinic visit |
| BG001 | Insulin+Pramlintide to Insulin-only | Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Then they will return after washout period to use the closed loop system with insulin-only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. For both arms, sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up. | Count of Participants | Participants |
|
| Race (NIH/OMB) | A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up. | Count of Participants | Participants |
|
| Weight in kg | A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up. | Mean | Standard Deviation | kg |
|
| Hemoglobin A1c | A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up. | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
|
| Duration of diabetes | A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up. | Mean | Standard Deviation | years |
|
| Glucose at start of pramlintide arm | A total of 33 subjects were randomized into the study. Two participants withdrew from the study before study treatment began, one due to scheduling conflicts and the other was lost to follow-up. | Mean | Standard Deviation | mg/dl |
|
| Glucose at start of insulin-only arm | Mean | Standard Deviation | mg/dl |
|
| OG001 | Insulin Only Arm | Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic. |
|
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| Primary | Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following First Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design | Posted | Mean | Standard Deviation | Percent time in range | 6 hours following first meal |
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| Secondary | Incremental Area Under the Curve of Postprandial Glucose Following the Second Meal | Incremental area under the curve (iAUC) of postprandial glucose (mg/dL*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose for the obseration period. Values shown are iAUC/1000. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant. | Posted | Mean | Standard Deviation | (mg/dl*min)/1000 | 6 hours following second meal |
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| Secondary | Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following Second Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant. | Posted | Mean | Standard Deviation | Percent time in range | 6 hours following second meal |
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| Secondary | Net Area Under the Curve of Postprandial Glucose Following the First Meal | Net area under the curve (netAUC) of postprandial glucose (mg/dL*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose and subtracts CGM values below the starting glucose for the observation period. Values shown are (mg/dL*min)/1000. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Mean | Standard Deviation | (mg/dL*min)/1000 | 6 hours following first meal |
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| Secondary | Net Area Under the Curve of Postprandial Glucose Following the Second Meal | Net area under the curve (netAUC) of postprandial glucose (mg/dL*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose and subtracts CGM values below the starting glucose for the observation period. Values shown are (mg/dl *min)/1000 | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant. | Posted | Mean | Standard Deviation | (mg/dl *min)/1000 | 6 hours following second meal |
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| Secondary | Net Area Under the Curve of Postprandial Glucose | Net area under the curve (netAUC) of postprandial glucose (mg/dL*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose and subtracts CGM values below the starting glucose for the observation period. Values shown are (mg/dL*min)/1000. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Mean | Standard Deviation | (mg/dL*min)/1000 | 12 hour clinic visit |
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| Secondary | Percent of Time With Sensed Glucose <70 mg/dL Following First Meal | Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor in the 6 hours following the start of the first meal. Because so few participants had any sensed glucose values <70 mg/dL, this summary shows the count of participants with any time (>0) with sensed glucose <70 mg/dL | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Count of Participants | Participants | 6 hours following first meal |
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| Secondary | Percent of Time With Sensed Glucose <70 mg/dL Following Second Meal | Because so few participants had any sensed glucose values <70 mg/dL, this summary shows the count of participants with any time (>0) with sensed glucose <70 mg/dL | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant. | Posted | Count of Participants | Participants | 6 hours following second meal |
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| Secondary | Percent of Time With Sensed Glucose <70 mg/dL | Because so few participants had any sensed glucose values <70 mg/dL, this summary shows the count of participants with any time (>0) with sensed glucose <70 mg/dL | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Count of Participants | Participants | 12 hour clinic visit |
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| Secondary | Percent of Time With Sensed Glucose Between 70-140 mg/dL Following First Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Median | Inter-Quartile Range | Percent time in range (mg/dl) | 6 hours following first meal |
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| Secondary | Percent of Time With Sensed Glucose Between 70-140 mg/dL Following Second Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant. | Posted | Median | Inter-Quartile Range | Percent time in range (mg/dl) | 6 hours following second meal |
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| Secondary | Percent of Time With Sensed Glucose Between 70-140 mg/dL | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the twelve hours of the clinic visit as the denominator. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Median | Inter-Quartile Range | Percent time in range (mg/dl) | 12 hour clinic visit |
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| Secondary | Mean Sensed Glucose Following First Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The outcome is calculated as the average of these values for the six hours following the meal. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Mean | Standard Deviation | mg/dL | 6 hours following first meal |
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| Secondary | Mean Sensed Glucose Following Second Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The outcome is calculated as the average of these values for the six hours following the meal. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant. | Posted | Mean | Standard Deviation | mg/dL | 6 hours following second meal |
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| Secondary | Mean Sensed Glucose | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The outcome is calculated as the average of these values for the twelve-hour clinic visit. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Mean | Standard Deviation | mg/dL | 12 hour clinic visit |
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| Secondary | Percent of Time With Sensed Glucose <54 mg/dL Following First Meal | Because so few participants had any sensed glucose values <54 mg/dL, this summary shows the count of participants with any time (>0) with sensed glucose <54 mg/dL | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Count of Participants | Participants | 6 hours following first meal |
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| Secondary | Percent of Time With Sensed Glucose <54 mg/dL Following Second Meal | Because so few participants had any sensed glucose values <54 mg/dL, this summary shows the count of participants with any time (>0) with sensed glucose <54 mg/dL | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant. | Posted | Count of Participants | Participants | 6 hours following second meal |
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| Secondary | Percent of Time With Sensed Glucose <54 mg/dL | Because so few participants had any sensed glucose values <54 mg/dL, this summary shows the count of participants with any time (>0) with sensed glucose <54 mg/dL. | Posted | Count of Participants | Participants | 12 hour clinic visit |
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| Secondary | Percent of Time With Sensed Glucose >180 mg/dL Following First Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Mean | Standard Deviation | Percent time in range | 6 hours following first meal |
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| Secondary | Percent of Time With Sensed Glucose >180 mg/dL Following Second Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant. | Posted | Mean | Standard Deviation | Percent time in range | 6 hours following second meal |
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| Secondary | Percent of Time With Sensed Glucose >180 mg/dL | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the twelve-hour clinic visit as the denominator. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Mean | Standard Deviation | percent of time | 12 hour clinic visit |
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| Secondary | Percent of Time With Sensed Glucose >250 mg/dL Following First Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours after the meal as the denominator. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Median | Inter-Quartile Range | Percent time in range | 6 hours following first meal |
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| Secondary | Percent of Time With Sensed Glucose >250 mg/dL Following Second Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours after the meal as the denominator. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant. | Posted | Median | Inter-Quartile Range | Percent time in range | 6 hours following second meal |
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| Secondary | Percent of Time With Sensed Glucose >250 mg/dL | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the twelve hours of the clinic visit as the denominator. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Median | Inter-Quartile Range | Percent time in range | 12 hour clinic visit |
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| Secondary | Median Amount of Insulin Delivered Following First Meal | Amount of insulin (units) delivered in the 6 hours following the first meal. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Median and quartiles reported for insulin and pramlintide, rather than mean, because the distribution is right-skewed. | Posted | Median | Inter-Quartile Range | Units | 6 hours following the first meal |
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| Secondary | Median Amount of Insulin Delivered Following Second Meal | Amount of insulin (units) delivered. in the 6 hours following the second meal. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant. | Posted | Median | Inter-Quartile Range | Units | 6 hours following the second meal |
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| Secondary | Median Amount of Insulin Delivered | Amount of insulin (units) delivered | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Median | Inter-Quartile Range | Units | 12 hour clinic visit |
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| Secondary | Median Amount of Pramlintide Delivered Following First Meal | Amount of pramlintide (mcg) delivered in the 6 hours following the first meal. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Median | Inter-Quartile Range | mcg | 6 hours following the first meal |
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| Secondary | Median Amount of Pramlintide Delivered Following Second Meal | Amount of pramlintide (mcg) delivered in the 6 hours following the second meal. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant. | Posted | Median | Inter-Quartile Range | mcg | 6 hours following the second meal |
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| Secondary | Median Amount of Pramlintide Delivered | Amount of pramlintide (mcg) delivered | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Median | Inter-Quartile Range | mcg | 12 hour clinic visit |
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| Secondary | Coefficient of Variation Following First Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The coefficient of variation outcome is calculated as (100 * [standard deviation] / mean) of these values for the six hours following the meal. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Mean | Standard Deviation | Unitless | 6 hours following the first meal |
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| Secondary | Coefficient of Variation Following Second Meal | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The coefficient of variation outcome is calculated as (100 * [standard deviation] / mean) of these values for the six hours following the meal. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant. | Posted | Mean | Standard Deviation | Unitless | 6 hours following the second meal |
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| Secondary | Coefficient of Variation | Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The coefficient of variation outcome is calculated as (100 * [standard deviation] / mean) of these values for the twelve hours in the clinic. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Mean | Standard Deviation | Unitless | 12 hour clinic visit |
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| Secondary | Low Blood Glucose Index (LBGI) Following the First Meal | The Low Blood Glucose Index (LBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138 | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Count of Participants | Participants | 6 hours following the first meal |
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| Secondary | Low Blood Glucose Index (LBGI) Following the Second Meal | The Low Blood Glucose Index (LBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138 | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant. | Posted | Count of Participants | Participants | 6 hours following the second meal |
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| Secondary | Low Blood Glucose Index (LBGI) | The Low Blood Glucose Index (LBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138 | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Count of Participants | Participants | 12 hour clinic visit |
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| Secondary | High Blood Glucose Index (HBGI) Following the First Meal | The High Blood Glucose Index (HBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138 | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Count of Participants | Participants | 6 hours following the first meal |
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| Secondary | High Blood Glucose Index (HBGI) Following the Second Meal | The High Blood Glucose Index (HBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138 | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant. | Posted | Count of Participants | Participants | 6 hours following the second meal |
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| Secondary | High Blood Glucose Index (HBGI) | The High Blood Glucose Index (HBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138 | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Count of Participants | Participants | 12 hour clinic visit |
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| Secondary | Adverse Events Related to Pramlintide | Assess the number of adverse events probably or possibly associated with pramlintide administration. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Number | Number of events | 4 days of pramlintide use |
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| Secondary | Baxter Retching Faces (BARF) Visual Analog Scale for Gastrointestinal Issues After the First Meal | Six hours after the meal, participants were asked to use the Baxter Retching Faces (BARF) visual analog scale to indicate the worst nausea/vomiting discomfort they felt over the prior 6 hours. The scale ranges from 0 (none) to 10 (most discomfort). | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Median | Full Range | score on the scale | 6 hours following first meal |
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| Secondary | Baxter Retching Faces (BARF) Visual Analog Scale for Gastrointestinal Issues After the Second Meal | Six hours after the meal, participants were asked to use the Baxter Retching Faces (BARF) visual analog scale to indicate the worst nausea/vomiting discomfort they felt over the prior 6 hours. The scale ranges from 0 (none) to 10 (most discomfort). | Posted | Median | Full Range | score on the scale | 6 hours following second meal |
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| Secondary | Mean Duration of Gastrointestinal Issues After the First Meal | Six hours after the meal, participants were asked to report the approximate number of minutes they felt nausea during the prior 6 hours. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Mean | Full Range | Minutes | 6 hours following first meal |
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| Secondary | Mean Duration of Gastrointestinal Issues After the Second Meal | Six hours after the meal, participants were asked to report the approximate number of minutes they felt nausea during the prior 6 hours. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. Unequal sample sizes reflect one missing meal for one participant. | Posted | Mean | Full Range | Minutes | 6 hours following second meal |
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| Secondary | Episodes of Hypoglycemia | Counts of the number of episodes when the continuous glucose monitoring (CGM) values were <70 mg/dL for 10 minutes or more. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Count of Participants | Participants | 12 hour clinic visit |
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| Secondary | Episodes of Carbohydrate Intake to Treat Hypoglycemia | Assess the number of rescue carbohydrate treatments (defined as 15 grams of carbohydrate intake) needed to treat hypoglycemia. | All participants who completed at least one six-hour observation period. Participants completed both arms in a crossover design. | Posted | Mean | Standard Deviation | number of events | 12 hour clinic visit |
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| Secondary | Number of Provider-administered Insulin Injections | Assess the number of provider-administered insulin injections due to hyperglycemia. | Posted | Mean | Standard Deviation | count of injections | 12 hour clinic visit |
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| 0 |
| 31 |
| 0 |
| 31 |
| 17 |
| 31 |
| EG001 | Insulin and Pramlintide Arm | Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic. | 0 | 31 | 0 | 31 | 0 | 31 |
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Moderate risk (2.5 <LBGI <=5) |
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| Moderate risk (2.5 <LBGI <=5) |
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| Moderate risk (2.5 <LBGI <=5) |
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| High risk (>9) |
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| High risk (>9) |
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| High risk (>9) |
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| 2 |
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| 3 |
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