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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
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An artificial pancreas (AP) is a control system for automatic insulin delivery. Our group has implemented a fading memory proportional derivative controller (FMPD) for use within an AP control system which has been evaluated in clinical studies. However, the long action of insulin (90 minutes for peak action) makes it challenging to control insulin with a classical proportional derivative system. The study described within this protocol is designed to test the effectiveness of a new model-predictive control (MPC) AP that modulates insulin delivery based on estimated activity level. The potential benefit of this type of AP is that it handles exercise not as a discrete event, but it automatically adjusts insulin delivery based on estimated activity level calculated at every 5 minute cycle. This type of algorithm may significantly improve glucose control over our FMPD AP, which is designed only to detect exercise when activity level goes above a threshold for a specific duration of 45 minutes.
Participants will undergo two approximately 76 hour studies. During each of these intervention visits, participants will wear an Omnipod to deliver insulin and a Dexcom G6 CGM to measure glucose. The CGM system will provide sensed glucose data every 5 minutes. Sensed glucose data will be wirelessly transmitted via Bluetooth Low Energy (BTLE) from the Dexcom G6 transmitter to the Samsung master controller every five minutes. The smart phone will wirelessly communicate via BTLE to an Omnipod through an Omnipod PDM. During one of the studies, glucose will be controlled using the MPC AP. During another study, glucose will be controlled using the FMPD AP. The AP system will receive activity data through a Polar M600 watch worn by the participant.
Participants will arrive at the clinic at approximately 7am for the inpatient visits. Participants will eat breakfast, lunch and dinner in the clinic. Participants will perform activities of daily living and exercise using an aerobic exercise video. Participants will discharge at 7pm to go home for the remainder of the study visit and perform one exercise video session at home. Participants will return to OHSU on Day 4 for removal of all devices. The exception to this is for the first 8 participants using the MPC AP. These participants will stay at the research clinic during the day and go home to sleep each night (7pm-7am).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMPD AP system | Experimental | Participants will use the FMPD AP system for automated insulin delivery for a 76 hour study visit. |
|
| MPC AP System | Experimental | Participants will use the MPC AP system for automated insulin delivery for a 76 hour study visit. |
|
| Dexcom G6 Training Arm | Experimental | Participants will use the Dexcom G6 CGM system within the MPC AP system to generate sensor glucose data during a 7 day period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMPD AP algorithm | Device | The Fading Memory Proportional Derivative (FMPD) insulin infusion algorithm determines insulin delivery rates based on proportional error, defined as the difference between the current CGM level and the target CGM level, and the derivative error, defined as the rate of change of the CGM. The FMPD algorithm utilizes derivative and proportional glucose errors to determine delivery rates of insulin. |
| 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 across the duration of the 12 hour inpatient stay (either Day 3 or Day 1 MPC vs. Day 1 FMPD). | 12 hour inpatient stay (either Day 3 or Day 1 MPC vs. Day 1 FMPD) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 across both arms. | During each 76 hour intervention study (2 total) |
| Percent of Time With Sensed Glucose Between 70 - 180 mg/dl |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37543512 | Derived | Jacobs PG, Resalat N, Hilts W, Young GM, Leitschuh J, Pinsonault J, El Youssef J, Branigan D, Gabo V, Eom J, Ramsey K, Dodier R, Mosquera-Lopez C, Wilson LM, Castle JR. Integrating metabolic expenditure information from wearable fitness sensors into an AI-augmented automated insulin delivery system: a randomised clinical trial. Lancet Digit Health. 2023 Sep;5(9):e607-e617. doi: 10.1016/S2589-7500(23)00112-7. Epub 2023 Aug 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MPC to FMPD | The randomization order for participants in this arm was Model Predictive Control (MPC) followed by Fading-Memory Proportional Derivative (FMPD). Each visit was about 76 hours and included an inpatient and outpatient portion. The first 8 participants using the MPC remained as inpatients in clinic during the day and went home with system turned off at night (7pm-7am). |
| FG001 | FMPD to MPC | The randomization order for participants in this arm was Fading-Memory Proportional Derivative (FMPD) followed by Model Predictive Control (MPC). Each visit was about 76 hours and included an inpatient and outpatient portion. The first 8 participants using the MPC remained as inpatients in clinic during the day and went home with system turned off at night (7pm-7am). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dexcom Training Visit (1 Week) |
| |||||||||||||
| First Rest Period (1-12 Weeks) |
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| First Intervention (~76 Hours) |
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| Second Rest Period (1-10 Weeks) |
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| Second Intervention Visit (~76 Hours) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MPC to FMPD | The randomization order for participants in this arm was Model Predictive Control (MPC) followed by Fading-Memory Proportional Derivative (FMPD). Each visit was about 72 hours and included a 12 hour inpatient and 60 hour outpatient portion. |
| BG001 | FMPD to MPC |
| 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 G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor across the duration of the 12 hour inpatient stay (either Day 3 or Day 1 MPC vs. Day 1 FMPD). | Out of 25 participants enrolled, the MPC study cancelled after 8 hours was not analyzed, the other three MPC studies that were cancelled after 30+ hours were analyzed. Two FMPD studies were cancelled the first day, 6 or 7 hours in and one FMPD study never happened as participant was withdrawn, so three FMPD studies were not analyzed. The other FMPD study that was cancelled after 28 hours was analyzed. | Posted | Mean | Standard Deviation | percentage of time | 12 hour inpatient stay (either Day 3 or Day 1 MPC vs. Day 1 FMPD) |
|
12 months
All participants that began/started the Dexcom training visit or an MPC or FMPD arm visit are included in the adverse events. The numbers from the participant flow indicate that 25 subjects began the Dexcom training visit, 25 subjects began an MPC visit and 24 subjects began an FMPD 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 76 hour study visit. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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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 | May 21, 2021 | 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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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| MPC AP system | 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. |
|
| Dexcom G6 Continuous Glucose Monitoring (CGM) System | Device | The Dexcom G6 CGM measures interstitial glucose through a sensor transmitter. This glucose value is reported to the MPC algorithm during this intervention. |
|
Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using Dexcom sensor across the duration of the 12 hour inpatient stay (either Day 3 or Day 1 MPC vs. Day 1 FMPD). |
| 12 hour inpatient stay (either Day 3 or Day 1 MPC vs. Day 1 FMPD) |
| Percent of Time With Sensed Glucose Between 70 - 180 mg/dl After Exercise | Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using Dexcom sensor across both arms from the start of the in-clinic exercise session until the start of the next meal. | start of the in-clinic exercise session until the start of the next meal, approximately 1 hour |
| Percent of Time With Sensed Glucose <70 mg/dl After Exercise | Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor across both arms from the start of the in-clinic exercise session until the start of the next meal. | start of the in-clinic exercise session until the start of the next meal, approximately 1 hour |
| Number of Carbohydrate Treatments | Assess the mean number of carbohydrate treatments (defined as 15 or 20 grams of carbohydrate) across both arms. | During each 76 hour intervention study (2 total) |
| Mean Sensed Glucose | Assess the mean sensed glucose from the Dexcom G6 reported sensor glucose values across both arms. The Dexcom G6 CGM updates every 5 minutes with a new CGM value for 10 days. The Dexcom G6 reads values between 40-400 mg/dL with an urgent low alert at 55 mg/dl, a low and high alert when CGM goes above or below the alert thresholds set by the user. Physiologically relevant thresholds for the Dexcom G6 CGM sensor glucose values are less than 55 mg/dl, less than 70 mg/dl, above 180 mg/dl and above 250 mg/dl. The Dexcom G6 target range is 70-180 mg/dl. | During each 76 hour intervention study (2 total) |
| Coefficient of Variation of Glucose | Assess the coefficient of variation of glucose from the Dexcom G6 reported sensor glucose values across both arms. The Dexcom G6 CGM updates every 5 minutes with a new CGM value for 10 days. The Dexcom G6 reads values between 40-400 mg/dL with an urgent low alert at 55 mg/dl, a low and high alert when CGM goes above or below the alert thresholds set by the user. Physiologically relevant thresholds for the Dexcom G6 CGM sensor glucose values are less than 55 mg/dl, less than 70 mg/dl, above 180 mg/dl and above 250 mg/dl. The Dexcom G6 target range is 70-180 mg/dl.The target coefficient of variation is 33% or lower. | During each 76 hour intervention study (2 total) |
| 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 across both arms | During each 76 hour intervention study (2 total) |
| 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 across both arms | During each 76 hour intervention study (2 total) |
| Mean Amount of Insulin Delivered Per Day (in Units/Day) | Assess the mean amount of insulin delivered per day by the Omnipod through the AP system study in units/kg across both arms. | During each 76 hour intervention study (2 total) |
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The randomization order for participants in this arm was Fading-Memory Proportional Derivative (FMPD) 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 | MPC AP System | Participants will use the MPC AP system for automated insulin delivery for a 76 hour study visit. MPC AP system: 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. |
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| Secondary | 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 across both arms. | Out of 25 participants enrolled, the MPC study cancelled after 8 hours was not analyzed, the other three MPC studies that were cancelled after 30+ hours were analyzed. Two FMPD studies were cancelled the first day, 6 or 7 hours in and one FMPD study never happened as participant was withdrawn, so three FMPD studies were not analyzed. The other FMPD study that was cancelled after 28 hours was analyzed. | Posted | Mean | Standard Deviation | percentage of time | During each 76 hour intervention study (2 total) |
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| Secondary | 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 across the duration of the 12 hour inpatient stay (either Day 3 or Day 1 MPC vs. Day 1 FMPD). | Out of 25 participants enrolled, the MPC study cancelled after 8 hours was not analyzed, the other three MPC studies that were cancelled after 30+ hours were analyzed. Two FMPD studies were cancelled the first day, 6 or 7 hours in and one FMPD study never happened as participant was withdrawn, so three FMPD studies were not analyzed. The other FMPD study that was cancelled after 28 hours was analyzed. | Posted | Mean | Standard Deviation | percentage of time | 12 hour inpatient stay (either Day 3 or Day 1 MPC vs. Day 1 FMPD) |
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| Secondary | Percent of Time With Sensed Glucose Between 70 - 180 mg/dl After Exercise | Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using Dexcom sensor across both arms from the start of the in-clinic exercise session until the start of the next meal. | Out of 25 participants enrolled, the MPC study cancelled after 8 hours was not analyzed, the other three MPC studies that were cancelled after 30+ hours were analyzed. Two FMPD studies were cancelled the first day, 6 or 7 hours in and one FMPD study never happened as participant was withdrawn, so three FMPD studies were not analyzed. The other FMPD study that was cancelled after 28 hours was analyzed. | Posted | Mean | Standard Deviation | percentage of time | start of the in-clinic exercise session until the start of the next meal, approximately 1 hour |
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| Secondary | Percent of Time With Sensed Glucose <70 mg/dl After Exercise | Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor across both arms from the start of the in-clinic exercise session until the start of the next meal. | Out of 25 participants enrolled, the MPC study cancelled after 8 hours was not analyzed, the other three MPC studies that were cancelled after 30+ hours were analyzed. Two FMPD studies were cancelled the first day, 6 or 7 hours in and one FMPD study never happened as participant was withdrawn, so three FMPD studies were not analyzed. The other FMPD study that was cancelled after 28 hours was analyzed. | Posted | Mean | Standard Deviation | percentage of time | start of the in-clinic exercise session until the start of the next meal, approximately 1 hour |
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| Secondary | Number of Carbohydrate Treatments | Assess the mean number of carbohydrate treatments (defined as 15 or 20 grams of carbohydrate) across both arms. | Out of 25 participants enrolled, the MPC study cancelled after 8 hours was not analyzed, the other three MPC studies that were cancelled after 30+ hours were analyzed. Two FMPD studies were cancelled the first day, 6 or 7 hours in and one FMPD study never happened as participant was withdrawn, so three FMPD studies were not analyzed. The other FMPD study that was cancelled after 28 hours was analyzed. | Posted | Mean | Standard Deviation | carbohydrate treatments/day | During each 76 hour intervention study (2 total) |
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| Secondary | Mean Sensed Glucose | Assess the mean sensed glucose from the Dexcom G6 reported sensor glucose values across both arms. The Dexcom G6 CGM updates every 5 minutes with a new CGM value for 10 days. The Dexcom G6 reads values between 40-400 mg/dL with an urgent low alert at 55 mg/dl, a low and high alert when CGM goes above or below the alert thresholds set by the user. Physiologically relevant thresholds for the Dexcom G6 CGM sensor glucose values are less than 55 mg/dl, less than 70 mg/dl, above 180 mg/dl and above 250 mg/dl. The Dexcom G6 target range is 70-180 mg/dl. | Out of 25 participants enrolled, the MPC study cancelled after 8 hours was not analyzed, the other three MPC studies that were cancelled after 30+ hours were analyzed. Two FMPD studies were cancelled the first day, 6 or 7 hours in and one FMPD study never happened as participant was withdrawn, so three FMPD studies were not analyzed. The other FMPD study that was cancelled after 28 hours was analyzed. | Posted | Mean | Standard Deviation | mmol/L | During each 76 hour intervention study (2 total) |
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| Secondary | Coefficient of Variation of Glucose | Assess the coefficient of variation of glucose from the Dexcom G6 reported sensor glucose values across both arms. The Dexcom G6 CGM updates every 5 minutes with a new CGM value for 10 days. The Dexcom G6 reads values between 40-400 mg/dL with an urgent low alert at 55 mg/dl, a low and high alert when CGM goes above or below the alert thresholds set by the user. Physiologically relevant thresholds for the Dexcom G6 CGM sensor glucose values are less than 55 mg/dl, less than 70 mg/dl, above 180 mg/dl and above 250 mg/dl. The Dexcom G6 target range is 70-180 mg/dl.The target coefficient of variation is 33% or lower. | Out of 25 participants enrolled, the MPC study cancelled after 8 hours was not analyzed, the other three MPC studies that were cancelled after 30+ hours were analyzed. Two FMPD studies were cancelled the first day, 6 or 7 hours in and one FMPD study never happened as participant was withdrawn, so three FMPD studies were not analyzed. The other FMPD study that was cancelled after 28 hours was analyzed. | Posted | Mean | Standard Deviation | percentage | During each 76 hour intervention study (2 total) |
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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 across both arms | Out of 25 participants enrolled, the MPC study cancelled after 8 hours was not analyzed, the other three MPC studies that were cancelled after 30+ hours were analyzed. Two FMPD studies were cancelled the first day, 6 or 7 hours in and one FMPD study never happened as participant was withdrawn, so three FMPD studies were not analyzed. The other FMPD study that was cancelled after 28 hours was analyzed. | Posted | Mean | Standard Deviation | percentage of time | During each 76 hour intervention study (2 total) |
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| 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 across both arms | Out of 25 participants enrolled, the MPC study cancelled after 8 hours was not analyzed, the other three MPC studies that were cancelled after 30+ hours were analyzed. Two FMPD studies were cancelled the first day, 6 or 7 hours in and one FMPD study never happened as participant was withdrawn, so three FMPD studies were not analyzed. The other FMPD study that was cancelled after 28 hours was analyzed. | Posted | Mean | Standard Deviation | percentage of time | During each 76 hour intervention study (2 total) |
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| Secondary | Mean Amount of Insulin Delivered Per Day (in Units/Day) | Assess the mean amount of insulin delivered per day by the Omnipod through the AP system study in units/kg across both arms. | Out of 25 participants enrolled, the MPC study cancelled after 8 hours was not analyzed, the other three MPC studies that were cancelled after 30+ hours were analyzed. Two FMPD studies were cancelled the first day, 6 or 7 hours in and one FMPD study never happened as participant was withdrawn, so three FMPD studies were not analyzed. The other FMPD study that was cancelled after 28 hours was analyzed. | Posted | Mean | Standard Deviation | units/day | During each 76 hour intervention study (2 total) |
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| 0 |
| 25 |
| 0 |
| 25 |
| 1 |
| 25 |
| EG001 | FMPD AP System | Participants will use the FMPD AP system for automated insulin delivery for a 76 hour study visit. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | Dexcom G6 Training Arm | Participants will use the Dexcom G6 CGM with the MPC AP algorithm for acquiring sensor glucose values. | 0 | 25 | 0 | 25 | 1 | 25 |
| Back Sprain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| High ketones | Blood and lymphatic system disorders | Systematic Assessment | Ketones measured by Precision Xtra blood ketone meter |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |