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| Name | Class |
|---|---|
| University of Washington | OTHER |
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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. If a meal is detected that was not reported by the user, the system shall calculate the amount of meal insulin that will be dosed and deliver that insulin. The investigators will test how well the new algorithm manages glucose compared to the participant's usual care including the tslim X2 pump with Control IQ enabled. This type of algorithm may improve glucose control for high risk patient populations.
Participants will undergo one 7-day Intervention Period and one 7-day Control Period in randomized order. During the 7-day intervention, participants will wear an Omnipod to deliver Fiasp insulin and a Dexcom G6 CGM. The CGM system will provide sensed 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 one meal in clinic and complete system training on Day 1 and then spend the rest of the 7 days at home. During the 7-day control, the participant will continue their usual diabetes care regimen using the tslim X2 pump with Dexcom G6 with Control IQ enabled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MPC Arm | Experimental | Participants will use the MPC closed-loop system for 7 days using Fiasp insulin. The first 6 hours will be spent in clinic being trained on the system, then eating a meal. Then the participant will take the system home to continue using for 7 days. |
|
| Control IQ arm | Active Comparator | Participants will continue their normal diabetes regimen which includes the t:slim X2 pump with Dexcom G6 CGM and Control IQ for 7 days. Participants will share their pump download and Dexcom Clarity data with study staff after the 7 days is complete. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MPC closed-loop 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 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. |
| 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. | 7 days in each treatment arm |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days in each treatment arm |
| Percent of Time With Sensed Glucose < 70 mg/dl |
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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 | ||
| University of Washington |
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42 people were screened between March of 2023 to December of 2024 at hospital associated specialty clinic in Oregon Health and Science University and University of Washington with 13 people that did not meet screening criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | MPC to Control | Participants used the MPC closed-loop system for 7 days using Fiasp insulin. They spent first 6 hours in clinic being trained on the system, then eating a meal. Then the participant took the system home to continue using for 7 days. After the 7 days were complete, the participant was returned to their usual care insulin regimen and study supplies were returned. |
| FG001 | Control to MPC | Participants continued their normal diabetes regimen which includes their usual care automated insulin delivery system with Dexcom G6 CGM for 7 days. Participants shared their pump download and Dexcom Clarity data with study staff after the 7 days was complete. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures.
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| ID | Title | Description |
|---|---|---|
| BG000 | MPC to Control | Participants used the MPC closed-loop system for 7 days using Fiasp insulin. They spent first 6 hours in clinic being trained on the system, then eating a meal. Then the participant took the system home to continue using for 7 days. After the 7 days were complete, the participant was returned to their usual care insulin regimen and study supplies were returned. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures. |
| 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 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. | 2 enrolled participants were withdrawn from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures. | Posted | Dec 2025 | Mean | Standard Deviation | Percent (%) | 7 days in each treatment arm |
|
Up to 22 weeks
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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 Intervention Arm | Participants used the MPC closed-loop system for 7 days using Fiasp insulin. They spent first 6 hours in clinic being trained on the system, then eating a meal. Then the participant took the system home to continue using for 7 days. After the 7 days were complete, the participant was returned to their usual care insulin regimen and study supplies were returned. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device site reaction | Skin and subcutaneous tissue 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 14, 2024 | Dec 27, 2025 | Prot_SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol: Study Protocol | Oct 14, 2024 | Dec 27, 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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|
| t:slim X2 pump with Dexcom G6 CGM and Control IQ | Device | The t:slim pump is a hybrid closed-loop system available to consumers for automated insulin delivery. Control IQ technology automatically adjusts insulin levels based on continuous glucose monitoring (CGM) readings from Dexcom G6. |
|
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor across both arms. |
| 7 days in each treatment arm |
| 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. | 7 days in each treatment arm |
| Mean Sensed Glucose | Mean sensed glucose from the Dexcom G6 reported sensor glucose values. 7 days in each treatment arm: Sensed Glucose values were averaged across the 7 days for MPC Intervention and and across the 7 days for Control | 7 days in each treatment arm |
| Coefficient of Variation of Glucose (Unitless) | Continuous glucose monitoring (CGM) values were recorded every five minutes and summarized for each treatment arm. Coefficient of variation was calculated as 100 * (standard deviation) / (mean) of sensed glucose. Lower values are desirable for this outcome. This is a ratio. Thus, there are no units for this outcome. | 7 days in each treatment arm |
| Mean Amount of Insulin Delivered Per Day (in Units/kg) | Access the mean amount of insulin delivered per day by the Omnipod through the AP system study in units/kg across both arms. | 7 days in each treatment arm |
| Seattle |
| Washington |
| 98105 |
| United States |
| BG001 | Control to MPC | Participants continued their normal diabetes regimen which includes their usual care automated insulin delivery system with Dexcom G6 CGM for 7 days. Participants shared their pump download and Dexcom Clarity data with study staff after the 7 days was complete. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures. | Mean | Standard Deviation | Years |
|
| Race (NIH/OMB) | 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures. | Count of Participants | Participants |
|
| Weight (kg) | 2 enrolled participants withdrew from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures. | Mean | Standard Deviation | kg |
|
| OG001 | Control | Participants will continue their normal diabetes regimen which includes the t:slim X2 pump with Dexcom G6 CGM and Control IQ for 7 days. Participants will share their pump download and Dexcom Clarity data with study staff after the 7 days is complete. |
|
|
| 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. | Posted | Mean | Standard Deviation | Percent (%) | 7 days in each treatment arm |
|
|
|
| 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 across both arms. | 2 enrolled participants were withdrawn from the study due to scheduling conflicts; 1 participant was withdrawn due to diagnosis of DKA after randomization but before completing any study procedures and 1 participant was withdrawn due to an unrelated adverse event (viral infection) after randomization but before completing any study procedures. | Posted | Mean | Standard Deviation | Percent (%) | 7 days in each treatment arm |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Percent (%) | 7 days in each treatment arm |
|
|
|
| Secondary | Mean Sensed Glucose | Mean sensed glucose from the Dexcom G6 reported sensor glucose values. 7 days in each treatment arm: Sensed Glucose values were averaged across the 7 days for MPC Intervention and and across the 7 days for Control | Posted | Mean | Standard Deviation | mg/dl | 7 days in each treatment arm |
|
|
|
| Secondary | Coefficient of Variation of Glucose (Unitless) | Continuous glucose monitoring (CGM) values were recorded every five minutes and summarized for each treatment arm. Coefficient of variation was calculated as 100 * (standard deviation) / (mean) of sensed glucose. Lower values are desirable for this outcome. This is a ratio. Thus, there are no units for this outcome. | Posted | Mean | Standard Deviation | Unitless | 7 days in each treatment arm |
|
|
|
| Secondary | Mean Amount of Insulin Delivered Per Day (in Units/kg) | Access the mean amount of insulin delivered per day by the Omnipod through the AP system study in units/kg across both arms. | Posted | Mean | Standard Deviation | Units/kg | 7 days in each treatment arm |
|
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|
| 0 |
| 25 |
| 0 |
| 25 |
| 3 |
| 25 |
| EG001 | Control Arm | Participants continued their normal diabetes regimen which includes their usual care automated insulin delivery system with Dexcom G6 CGM for 7 days. Participants shared their pump download and Dexcom Clarity data with study staff after the 7 days was complete. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |