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The study team will be comparing two investigational Artificial Pancreas (AP) systems that the UVA Center for Diabetes Technology has developed. An artificial pancreas system delivers insulin automatically based on a blood glucose level that is provided from a continuous glucose monitor (CGM).
Maintaining blood glucose (BG) control among adolescents with Type 1 diabetes (T1D) is arguably the greatest challenge in the entire field of T1D. One reason for this poor control relates to missed meal boluses, which affects 65% of adolescents at least once weekly, with 38% missing at least 15% of their boluses. Adolescents who miss four boluses weekly experience an increase of 1% in their HbA1c. While the advent of the artificial pancreas (AP) offers promise of safe reductions in HbA1c, the study team previously found that the AP only partly compensates for missed prandial insulin -demonstrating that some form of meal announcement is necessary for good BG control, even with an AP. One way to automate this process is by sharing the prandial dosing responsibilities between an automated insulin priming (based on continuous glucose monitor condition predictive of a safe situation for such insulin dosing) and a closed loop controller capable of reconstructing (estimating) the prevailing glucose rate of appearance from an unannounced meal. The study team has developed such an insulin priming schema and integrated it into a new version of the robust Model Predictive Controller University of Virginia AP system (called the RocketAP).
In the current study, the investigators are testing this new AP system in two configurations: hybrid and fully automated, among up to 20 adolescents. The primary outcome will be one of efficacy in assessing how well the new system controls post-prandial BG in the absence of carbohydrate (CHO) announcement as compared to the same situation but using the Control-IQ closed loop algorithm, also designed at UVa and using the same modular architecture and safety system, but without insulin priming and with a less advanced model-based controller. Further comparisons will be made to BG control on RocketAP with CHO announcement and on Control-IQ with CHO announcement. Adolescents will be started on the respective University of Virginia AP systems (RocketAP and Control-IQ in random order, both implemented on the DiAs platform, MAF 2109) and followed over the course of two dinners on each of the two platforms: a dinner where CHO is announced as normal and the 2nd where no announcement is made.
The study team hypothesize that performances of RocketAP in fully automated mode will lie in between Hybrid and Fully Automated Control-IQ. In time, this may provide an opportunity to improve BG control among adolescents who miss meal announcement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RocketAP | Experimental | Adolescents will be assessed for a 48-70 hour period on the Rocket AP. This time will include two dinner times, one with and one without announcement of carbohydrate content. This is a cross-over study, so all participants will also be tested on the USS Virginia system under the same conditions. |
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| USS Virginia | Active Comparator | Adolescents will be assessed for a 48-70 hour period on the USS Virginia system. This time will include two dinner times, one with and one without announcement of carbohydrate content. This is a cross-over study, so all participants will also be tested on the Rocket AP system under the same conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RocketAP | Device | Artificial pancreas system which is designed to be able to identify when you have eaten and provide insulin for this meal |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range 70-180 mg/dL in the Unannounced Meal | Percentage of time from dinner time until midnight with blood glucose in range 70-180 mg/dL in the unannounced meal | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hypoglycemia Events From Dinner Time Until Midnight | Number of hypoglycemia events from dinner time until midnight | 6 hours |
| Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range < 70 mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark D DeBoer, MD, MSc, MCR | University of Virginia Center for Diabetes Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | 22904 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34400480 | Result | Garcia-Tirado J, Diaz JL, Esquivel-Zuniga R, Koravi CLK, Corbett JP, Dawson M, Wakeman C, Barnett CL, Oliveri MC, Myers H, Krauthause K, Breton MD, DeBoer MD. Advanced Closed-Loop Control System Improves Postprandial Glycemic Control Compared With a Hybrid Closed-Loop System Following Unannounced Meal. Diabetes Care. 2021 Aug 15:dc210932. doi: 10.2337/dc21-0932. Online ahead of print. |
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Pending
Generally will be available after publications completed.
No restrictions for access.
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Following study enrollment, participants were trained in the study devices. This study visit was followed by 4 weeks of CGM and pump data collection at the participant's home/usual routine. From the 21 enrolled participants, 1 did not follow up and 2 tested positive for SARS-co-V2 and were excluded from the study.
21 subjects were recruited from October 2020 to mid-December 2020 either in person (UVA CDT facility) or by video conference.
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| ID | Title | Description |
|---|---|---|
| FG000 | RocketAP First, Then USS Virginia | Participants were randomized following the Data Collection Phase in a 1:1 ratio. Participants in the Experimental-Control Arm underwent the Experimental Admission first, utilizing a meal-related fully automated artificial pancreas (AP) controller (RocketAP), followed by the Control Admission, which utilized a hybrid AP controller (USS-Virginia) with no washout period in between. During the 96-hour admission, study participants started using RocketAP (48h) around midday on Day 1 and switched to USS Virginia (48h) at midday on Day 3. Every 48-hour part of the admission consisted of quiet activities during the morning, lunch at 13:00, light walk at 17:00, dinner at 18:00, and quiet activities during the evening. Days 2 and 4 differed from Days 1 and 3, respectively, by the dinner announcements, i.e., dinner was not announced over Days 1 and 3 and was announced over Days 2 and 4. |
| FG001 | USS Virginia First, Then Rocket AP | Participants were randomized following the Data Collection Phase in a 1:1 ratio. Participants in the Control-Experimental Arm underwent the Control Admission first, utilizing a hybrid AP controller (USS-Virginia) first followed by a meal-related fully automated artificial pancreas (AP) controller (RocketAP) with no washout period in between. During the 96-hour admission, study participants started with USS Virginia (48h) around midday on Day 1 and switched to RocketAP (48h) at midday on Day 3. Every 48-hour part of the admission consisted of quiet activities during the morning, lunch at 13:00, light walk at 17:00, dinner at 18:00, and quiet activities during the evening. Days 2 and 4 differed from Days 1 and 3, respectively, by the dinner announcements, i.e., dinner was not announced over Days 1 and 3 and was announced over Days 2 and 4. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | RocketAP First, Then USS Virginia | Participants were randomized following the Data Collection Phase in a 1:1 ratio. Participants in the Experimental-Control Arm underwent the Experimental Admission first, utilizing a meal-related fully automated artificial pancreas (AP) controller (RocketAP), followed by the Control Admission, which utilized a hybrid AP controller (USS-Virginia) with no washout period in between. During the 96-hour admission, study participants started using RocketAP (48h) around midday on Day 1 and switched to USS Virginia (48h) at midday on Day 3. Every 48-hour part of the admission consisted of quiet activities during the morning, lunch at 13:00, light walk at 17:00, dinner at 18:00, and quiet activities during the evening. Days 2 and 4 differed from Days 1 and 3, respectively, by the dinner announcements, i.e., dinner was not announced over Days 1 and 3 and was announced over Days 2 and 4. |
| 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 | Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range 70-180 mg/dL in the Unannounced Meal | Percentage of time from dinner time until midnight with blood glucose in range 70-180 mg/dL in the unannounced meal | Posted | Median | Inter-Quartile Range | %Time in Range (TIR) | 6 hours |
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46h
nothing to disclose in this field
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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 | RocketAP | Adolescents will be assessed for a 48-hour period on Rocket AP (Experimental condition). This study portion included two dinners over two consecutive days, one with and one without timing/carbohydrate content announcement. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark DeBoer | University of Virginia | 1 434 924 0123 | mdd5z@virginia.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 | Nov 17, 2020 | Nov 17, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 17, 2020 | Feb 10, 2022 | ICF_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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A randomized cross-over trial assessing glycemic responses to two different approaches to insulin dosing for carbohydrate ingestion (announced vs. unannounced), with two different AP systems (RocketAP vs. USS Virginia, aka Control-IQ, in random order)
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| USS Virginia | Device | Artificial pancreas system which responds to glucose fluctuations by modulating insulin delivery but does not specifically detect meal ingestion |
|
Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range < 70 mg/dL
| 6 hours |
| Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >180 mg/dL | Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >180 mg/dL | 6 hours |
| Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >250 mg/dL | Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >250 mg/dL | 6 hours |
| Units of Insulin Injected From Dinner Time Until Midnight | Units of insulin injected from dinner time until midnight | 6 hours |
| The Blood Glucose Area Under the Curve (AUC) From Dinner Until Midnight, Accounting for the Initial Blood Glucose Value | The blood glucose area under the curve (AUC) from dinner until midnight, accounting for the initial blood glucose value. | 6 hours |
| Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range 70-180 mg/dL | Percentage of time from dinner time until dinner time + 12h with blood glucose in range 70-180 mg/dL | 12 hours |
| Number of Hypoglycemia Events From Dinner Time Until Dinner Time + 12h | Number of hypoglycemia events from dinner Time until dinner time + 12h | 12 hours |
| Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range <70 mg/dL | Percentage of time from dinner time until dinner time + 12h with blood Glucose in range <70 mg/dL | 12 hours |
| Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >180 mg/dL | Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >180 mg/dL | 12 hours |
| Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >250 mg/dL | Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >250 mg/dL | 12 hours |
| Units of Insulin Injected From Dinner Time Until Dinner Time + 12h | Units of insulin injected from dinner time until dinner time + 12h | 12 hours |
| The Blood Glucose Area Under the Curve (AUC) From Dinner Until Dinner + 12h, Accounting for the Initial Blood Glucose Value | The Blood Glucose Area Under the Curve (AUC) From Dinner Until dinner + 12h, Accounting for the Initial Blood Glucose Value | 12 hours |
| Percentage of Time Outside the Dinner Sessions With Blood Glucose in Range 70-180 mg/dL | Percentage of Time outside the dinner sessions With Blood Glucose in Range 70-180 mg/dL | 36 hours |
| Number of Hypoglycemia Events Outside of the Study Dinner Sessions | Number of hypoglycemia events outside of the Study Dinner Sessions | 36 hours |
| Percentage of Time Outside of the Study Dinner Sessions With Blood Glucose <70 mg/dL | Percentage of Time outside of the Study Dinner Sessions with Blood Glucose <70 mg/dL | 36 hours |
| Percent of Time Outside of the Study Dinner Sessions With Blood Glucose >180 mg/dL | Percent of Time Outside of the Study Dinner Sessions with Blood Glucose >180 mg/dL | 36 hours |
| Percent Time Outside of the Study Dinner Sessions With Blood Glucose >250 mg/dL | Percent Time Outside of the Study Dinner Sessions with Blood Glucose >250 mg/dL | 36 hours |
| Units of Insulin Injected Outside of the Study Dinner Sessions | Units of insulin injected outside of the Study Dinner Sessions | 36 hours |
| BG001 | USS Virginia First, Then Rocket AP | Participants were randomized following the Data Collection Phase in a 1:1 ratio. Participants in the Control-Experimental Arm underwent the Control Admission first, utilizing a hybrid AP controller (USS-Virginia) first followed by a meal-related fully automated artificial pancreas (AP) controller (RocketAP) with no washout period in between. During the 96-hour admission, study participants started with USS Virginia (48h) around midday on Day 1 and switched to RocketAP (48h) at midday on Day 3. Every 48-hour part of the admission consisted of quiet activities during the morning, lunch at 13:00, light walk at 17:00, dinner at 18:00, and quiet activities during the evening. Days 2 and 4 differed from Days 1 and 3, respectively, by the dinner announcements, i.e., dinner was not announced over Days 1 and 3 and was announced over Days 2 and 4. |
| 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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| HbA1c | Mean | Standard Deviation | % of HbA1c |
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| Weight | Mean | Standard Deviation | kg |
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| Height | Mean | Standard Deviation | cm |
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| Duration of diabetes | Mean | Standard Deviation | years |
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| Total daily insulin | Mean | Standard Deviation | IU |
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| Carbohydrate ratio | Insulin-to-carb ratio (ICR), also known as carbohydrate ratio (CR) or carbohydrate factor, is a calculation used to determine how many grams of carbs are covered by one unit of rapid-acting insulin for a person with diabetes. | Mean | Standard Deviation | g CHO per IU of insulin |
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| Correction factor | A Correction Factor (sometimes called insulin sensitivity), is how much 1 unit of rapid-acting insulin will generally lower the blood glucose (in mg/dL) of a given insulin-dependent person with diabetes. | Mean | Standard Deviation | mg/dL glucose per IU insulin |
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| basal rate profile | The basal rate is the amount of insulin per unit of time (h) that a given insulin-dependent person with diabetes needs to cover non-meal needs. Over a 24-hour period, the basal flow of insulin accounts for about 50% of a person's total daily insulin requirement. | Mean | Standard Deviation | IU/h |
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| Secondary | Number of Hypoglycemia Events From Dinner Time Until Midnight | Number of hypoglycemia events from dinner time until midnight | Posted | Median | Inter-Quartile Range | hypoglycemic event | 6 hours |
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| Secondary | Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range < 70 mg/dL | Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range < 70 mg/dL | Posted | Median | Inter-Quartile Range | % time<70mg/dL | 6 hours |
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| Secondary | Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >180 mg/dL | Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >180 mg/dL | Posted | Median | Inter-Quartile Range | % time>180mg/dL | 6 hours |
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| Secondary | Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >250 mg/dL | Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >250 mg/dL | Posted | Median | Inter-Quartile Range | % time>250mg/dL | 6 hours |
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| Secondary | Units of Insulin Injected From Dinner Time Until Midnight | Units of insulin injected from dinner time until midnight | Posted | Mean | Standard Deviation | IU of insulin | 6 hours |
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| Secondary | The Blood Glucose Area Under the Curve (AUC) From Dinner Until Midnight, Accounting for the Initial Blood Glucose Value | The blood glucose area under the curve (AUC) from dinner until midnight, accounting for the initial blood glucose value. | Posted | Mean | Standard Deviation | mg/dL * min | 6 hours |
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| Secondary | Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range 70-180 mg/dL | Percentage of time from dinner time until dinner time + 12h with blood glucose in range 70-180 mg/dL | Posted | Median | Inter-Quartile Range | %Time in Range (TIR) | 12 hours |
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| Secondary | Number of Hypoglycemia Events From Dinner Time Until Dinner Time + 12h | Number of hypoglycemia events from dinner Time until dinner time + 12h | Posted | Median | Inter-Quartile Range | hypoglycemic event | 12 hours |
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| Secondary | Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range <70 mg/dL | Percentage of time from dinner time until dinner time + 12h with blood Glucose in range <70 mg/dL | Posted | Median | Inter-Quartile Range | % time<70mg/dL | 12 hours |
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| Secondary | Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >180 mg/dL | Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >180 mg/dL | Posted | Median | Inter-Quartile Range | % time>180mg/dL | 12 hours |
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| Secondary | Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >250 mg/dL | Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >250 mg/dL | Posted | Median | Inter-Quartile Range | % time>250mg/dL | 12 hours |
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| Secondary | Units of Insulin Injected From Dinner Time Until Dinner Time + 12h | Units of insulin injected from dinner time until dinner time + 12h | Posted | Mean | Standard Deviation | IU | 12 hours |
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| Secondary | The Blood Glucose Area Under the Curve (AUC) From Dinner Until Dinner + 12h, Accounting for the Initial Blood Glucose Value | The Blood Glucose Area Under the Curve (AUC) From Dinner Until dinner + 12h, Accounting for the Initial Blood Glucose Value | Posted | Mean | Standard Deviation | mg/dL * min | 12 hours |
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| Secondary | Percentage of Time Outside the Dinner Sessions With Blood Glucose in Range 70-180 mg/dL | Percentage of Time outside the dinner sessions With Blood Glucose in Range 70-180 mg/dL | Posted | Median | Inter-Quartile Range | %Time in Range (TIR) | 36 hours |
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| Secondary | Number of Hypoglycemia Events Outside of the Study Dinner Sessions | Number of hypoglycemia events outside of the Study Dinner Sessions | Posted | Median | Inter-Quartile Range | hypoglycemic event | 36 hours |
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| Secondary | Percentage of Time Outside of the Study Dinner Sessions With Blood Glucose <70 mg/dL | Percentage of Time outside of the Study Dinner Sessions with Blood Glucose <70 mg/dL | Posted | Median | Inter-Quartile Range | % time<70mg/dL | 36 hours |
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| Secondary | Percent of Time Outside of the Study Dinner Sessions With Blood Glucose >180 mg/dL | Percent of Time Outside of the Study Dinner Sessions with Blood Glucose >180 mg/dL | Posted | Median | Inter-Quartile Range | % time>180mg/dL | 36 hours |
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| Secondary | Percent Time Outside of the Study Dinner Sessions With Blood Glucose >250 mg/dL | Percent Time Outside of the Study Dinner Sessions with Blood Glucose >250 mg/dL | Posted | Median | Inter-Quartile Range | % time>250mg/dL | 36 hours |
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| Secondary | Units of Insulin Injected Outside of the Study Dinner Sessions | Units of insulin injected outside of the Study Dinner Sessions | Posted | Mean | Standard Deviation | IU of insulin | 36 hours |
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| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | USS Virginia | Adolescents will be assessed for a 48-hour period on USS Virginia (Control condition). This study portion included two dinners over two consecutive days, one with and one without timing/carbohydrate content announcement. | 0 | 18 | 0 | 18 | 0 | 18 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |