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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DK120367-04 | 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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An artificial pancreas (AP) is a control system for automatic insulin delivery. The investigators have implemented a missed meal bolus detection algorithm for use within an AP control system. The robust R-AP system used in this protocol has been designed to handle a variety of real-world scenarios that are critical to a high-risk patient population. The investigators will test how well the new algorithm handles missed or inaccurate meal announcements. This type of algorithm may significantly improve glucose control over the standard model predictive control (MPC) closed-loop algorithm without these new algorithm features for patients with type 1 diabetes.
Participants will undergo two visits at Oregon Health and Science University (OHSU) that will evaluate missed meal bolus detection. Participants will arrive at approximately 7am for all visits, be monitored through the afternoon and discharged before dinner. During each of these intervention visits, participants will wear an Omnipod to deliver insulin and a Dexcom G6 Continuous Glucose Monitoring System (CGM) to measure glucose. The closed loop system will receive activity data through a Polar M600 watch worn by the participant. The studies will test the ability of the system to adapt to a missed meal bolus. Participants will eat self selected meals at 10 am and 2pm, both meals with a missed bolus, and these meals will be repeated across both study arms. For one missed meal bolus study, glucose will be controlled using the Robust R-AP closed-loop mode. During the other missed meal bolus study, glucose will be controlled using the MPC closed-loop mode. Participants will complete frequent glucose and ketone checks for safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MPC AP system | Experimental | Participants will use the MPC AP system for automated insulin delivery for a 9 hour study visit. |
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| Robust R-AP system | Experimental | Participants will use the Robust R-AP system for automated insulin delivery for a 9 hour study visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MPC AP algorithm | 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 inputs. The algorithm uses heart rate and accelerometer data collected on the patient's body to calculate metabolic expenditure. The metabolic expenditure 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) of Postprandial Glucose | Incremental AUC of postprandial glucose in the 4 hours following the start of first meal. AUC (mg/dL*hr) will be calculated using a trapezoidal method, which sums all CGM values taken every 5 minutes in the 4 hour period following the meal above the starting glucose. This yields a maximum of 48 data points for the calculation. | 4 hour period following the first meal |
| Percent of Time With Sensed Glucose Between 70-180 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using Dexcom sensor for the four hour period following the first meal. | 4 hour period following the first meal |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Time With Sensed Glucose <70 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor for the 4 hour period following the first meal. | 4 hour period following the first meal |
| Number of Carbohydrate Treatments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Jacobs, PhD | Oregon Health and Science University | Principal Investigator |
| 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 | MPC to R-AP | The randomization order for participants in this arm was Model Predictive Control (MPC) followed by Robust-Artificial Pancreas (R-AP). Each visit was about 8 hours long. |
| FG001 | R-AP to MPC | The randomization order for participants in this arm was Robust-Artificial Pancreas (R-AP followed by Model Predictive Control (MPC). Each visit was about 8 hours long. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dexcom Training Visit (30 Minutes) |
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| First Rest Period (1-12 Weeks) |
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| First Intervention (~8 Hours) |
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| Second at Home Period (3-30 Days) |
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| Second Intervention Visit (~8 Hours) |
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| ID | Title | Description |
|---|---|---|
| BG000 | MPC to R-AP | The randomization order for participants in this arm was Model Predictive Control (MPC) followed by Robust-Artificial Pancreas (R-AP). Each visit was about 72 hours and included a 12 hour inpatient and 60 hour outpatient portion. |
| BG001 | R-AP to MPC |
| 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 |
| 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 | Area Under the Curve (AUC) of Postprandial Glucose | Incremental AUC of postprandial glucose in the 4 hours following the start of first meal. AUC (mg/dL*hr) will be calculated using a trapezoidal method, which sums all CGM values taken every 5 minutes in the 4 hour period following the meal above the starting glucose. This yields a maximum of 48 data points for the calculation. | Posted | Mean | Standard Deviation | mg/dL*hr | 4 hour period following the first meal |
|
3 months
All participants that began/started the Dexcom training visit or a MPC or R-AP arm are included in the adverse events. The numbers from the participant flow indicate that 15 subjects began the Dexcom training visit, 15 subjects began an MPC visit and 15 subjects began an R-AP 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 | MPC AP System | Participants will use the MPC AP system for automated insulin delivery for a 9 hour study visit. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High ketones | Blood and lymphatic system disorders | Systematic Assessment | Blood ketones were measured at 3.4 mmol/L using Precision Xtra ketone meter. Patient was asymptomatic. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Castle | Oregon Health and Science University | 503-494-7072 | castleje@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2022 | Apr 20, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Robust R-AP algorithm | Device | The R-AP is a modified MPC algorithm. A new feature in the algorithm includes a model for missed meal insulin detection. The model includes estimations for carbohydrate consumption based glucose patterns to determine if that person has consumed a meal without announcing it to the system. |
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Assess the cumulative number of carbohydrate treatments (defined as 15 or 20 grams of carbohydrate) for the four hour period following the first meal. |
| 4 hour period following the first meal |
| Number of Provider-administered Insulin Injections | Assess the cumulative number of provider-administered insulin injections to treat hyperglycemia in the 4 hour period following the first meal. | 4 hour period following the first meal |
| Mean Sensed Glucose | Assess the mean sensed glucose from the Dexcom G6 reported sensor glucose values for the four hour period following the first meal. | 4 hour period following the first meal |
| Percent of Time With Sensed Glucose <54 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using Dexcom sensor for the four hour period following the first meal. | 4 hour period following the first meal |
| Percent of Time With Sensed Glucose >180 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 180 mg/dl using Dexcom sensor for the four hour period following the first meal. | 4 hour period following the first meal |
| Percent of Time With Sensed Glucose >250 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 250 mg/dl using Dexcom sensor for the four hour period following the first meal. | 4 hour period following the first meal |
| Mean Amount of Insulin Delivered Per Day (in Units) | Assess the mean amount of insulin delivered per day by the Omnipod through the AP system study in units for the four hour period following the first meal. | 4 hour period following the first meal |
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The randomization order for participants in this arm was Robust-Artificial Pancreas (R-AP followed by Model Predictive Control (MPC). Each visit was about 72 hours and included a 12 hour inpatient and 60 hour outpatient portion. |
| BG002 | Total | Total of all reporting groups |
| 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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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Robust R-AP System | Participants will use the Robust R-AP system for automated insulin delivery for a 9 hour study visit. Robust R-AP algorithm: The R-AP is a modified MPC algorithm. A new feature in the algorithm includes a model for missed meal insulin detection. The model includes estimations for carbohydrate consumption based glucose patterns to determine if that person has consumed a meal without announcing it to the system. |
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| Primary | Percent of Time With Sensed Glucose Between 70-180 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using Dexcom sensor for the four hour period following the first meal. | Posted | Mean | Standard Deviation | percentage of time | 4 hour period following the first meal |
|
|
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| Secondary | Percent of Time With Sensed Glucose <70 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor for the 4 hour period following the first meal. | Posted | Mean | Standard Deviation | percentage of time | 4 hour period following the first meal |
|
|
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| Secondary | Number of Carbohydrate Treatments | Assess the cumulative number of carbohydrate treatments (defined as 15 or 20 grams of carbohydrate) for the four hour period following the first meal. | Posted | Number | carbohydrate treatments | 4 hour period following the first meal |
|
|
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| Secondary | Number of Provider-administered Insulin Injections | Assess the cumulative number of provider-administered insulin injections to treat hyperglycemia in the 4 hour period following the first meal. | Posted | Number | insulin injections | 4 hour period following the first meal |
|
|
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| Secondary | Mean Sensed Glucose | Assess the mean sensed glucose from the Dexcom G6 reported sensor glucose values for the four hour period following the first meal. | Posted | Mean | Standard Deviation | mg/dL | 4 hour period following the first meal |
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| Secondary | Percent of Time With Sensed Glucose <54 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using Dexcom sensor for the four hour period following the first meal. | Posted | Mean | Standard Deviation | percentage of time | 4 hour period following the first meal |
|
|
|
| Secondary | Percent of Time With Sensed Glucose >180 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 180 mg/dl using Dexcom sensor for the four hour period following the first meal. | Posted | Mean | Standard Deviation | percentage of time | 4 hour period following the first meal |
|
|
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| Secondary | Percent of Time With Sensed Glucose >250 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 250 mg/dl using Dexcom sensor for the four hour period following the first meal. | Posted | Mean | Standard Deviation | percentage of time | 4 hour period following the first meal |
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| Secondary | Mean Amount of Insulin Delivered Per Day (in Units) | Assess the mean amount of insulin delivered per day by the Omnipod through the AP system study in units for the four hour period following the first meal. | Posted | Mean | Standard Deviation | units | 4 hour period following the first meal |
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| 0 |
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | Robust R-AP System | Participants will use the Robust R-AP system for automated insulin delivery for a 9 hour study visit. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |