Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes (RocketAP)
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| ClinicalTrials.gov Identifier: NCT04545567 |
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Recruitment Status :
Completed
First Posted : September 11, 2020
Results First Posted : March 31, 2022
Last Update Posted : April 20, 2022
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Other |
| Condition |
Type 1 Diabetes |
| Interventions |
Device: RocketAP Device: USS Virginia |
| Enrollment | 21 |
| Recruitment Details | 21 subjects were recruited from October 2020 to mid-December 2020 either in person (UVA CDT facility) or by video conference. |
| Pre-assignment Details | 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. |
| Arm/Group Title | RocketAP First, Then USS Virginia | USS Virginia First, Then Rocket AP |
|---|---|---|
 Arm/Group Description |
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. |
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. |
| Period Title: Overall Study | ||
| Started | 10 | 11 |
| Completed | 9 | 9 |
| Not Completed | 1 | 2 |
| Reason Not Completed | ||
| tested positive for SARS-co-V2 | 1 | 1 |
| Withdrawal by Subject | 0 | 1 |
| Arm/Group Title | RocketAP First, Then USS Virginia | USS Virginia First, Then Rocket AP | Total | |
|---|---|---|---|---|
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Arm/Group Description |
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. |
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. |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 9 | 9 | 18 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 9 participants | 9 participants | 18 participants | |
| <=18 years |
9 100.0%
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8 88.9%
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17 94.4%
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| Between 18 and 65 years |
0 0.0%
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1 11.1%
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1 5.6%
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| >=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 9 participants | 9 participants | 18 participants | |
| 15 (1.4) | 16 (2) | 16 (1.7) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 9 participants | 9 participants | 18 participants | |
| Female |
4 44.4%
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5 55.6%
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9 50.0%
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| Male |
5 55.6%
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4 44.4%
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9 50.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 9 participants | 9 participants | 18 participants | |
| Hispanic or Latino |
1 11.1%
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0 0.0%
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1 5.6%
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| Not Hispanic or Latino |
8 88.9%
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8 88.9%
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16 88.9%
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| Unknown or Not Reported |
0 0.0%
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1 11.1%
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1 5.6%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 9 participants | 9 participants | 18 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
0 0.0%
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0 0.0%
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0 0.0%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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| White |
8 88.9%
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9 100.0%
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17 94.4%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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|
| Unknown or Not Reported |
1 11.1%
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0 0.0%
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1 5.6%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 9 participants | 9 participants | 18 participants |
| 9 | 9 | 36 | ||
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HbA1c
Mean (Standard Deviation) Unit of measure: % of HbA1c |
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| Number Analyzed | 9 participants | 9 participants | 18 participants | |
| 7.7 (2) | 7.3 (1) | 7.4 (1.5) | ||
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Weight
Mean (Standard Deviation) Unit of measure: Kg |
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| Number Analyzed | 9 participants | 9 participants | 18 participants | |
| 65.2 (11.5) | 65.2 (11.5) | 65.2 (11.5) | ||
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Height
Mean (Standard Deviation) Unit of measure: Cm |
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| Number Analyzed | 9 participants | 9 participants | 18 participants | |
| 167 (9) | 167 (9) | 167 (9) | ||
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Duration of diabetes
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 9 participants | 9 participants | 18 participants | |
| 7.7 (3.2) | 7.7 (3.2) | 7.7 (3.2) | ||
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Total daily insulin
Mean (Standard Deviation) Unit of measure: IU |
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| Number Analyzed | 9 participants | 9 participants | 18 participants | |
| 60 (16.3) | 60 (16.3) | 60 (16.3) | ||
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Carbohydrate ratio
[1] Mean (Standard Deviation) Unit of measure: G CHO per IU of insulin |
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| Number Analyzed | 9 participants | 9 participants | 18 participants | |
| 7.7 (1.9) | 7.7 (1.9) | 7.7 (1.9) | ||
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[1]
Measure Description: 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.
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Correction factor
[1] Mean (Standard Deviation) Unit of measure: mg/dL glucose per IU insulin |
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| Number Analyzed | 9 participants | 9 participants | 18 participants | |
| 43 (18) | 43 (18) | 43 (18) | ||
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[1]
Measure Description: 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.
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basal rate profile
[1] Mean (Standard Deviation) Unit of measure: IU/h |
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| Number Analyzed | 9 participants | 9 participants | 18 participants | |
| 1.3 (0.4) | 1.3 (0.4) | 1.3 (0.4) | ||
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[1]
Measure Description: 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.
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| Name/Title: | Mark DeBoer |
| Organization: | University of Virginia |
| Phone: | 1 434 924 0123 |
| EMail: | mdd5z@virginia.edu |
| Responsible Party: | Mark D. DeBoer, MD, MSc., MCR, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT04545567 |
| Other Study ID Numbers: |
200235 |
| First Submitted: | September 3, 2020 |
| First Posted: | September 11, 2020 |
| Results First Submitted: | January 13, 2022 |
| Results First Posted: | March 31, 2022 |
| Last Update Posted: | April 20, 2022 |