Type 1 Diabetes
Conditions
Keywords
Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Insulin Pump, Closed Loop Control
Brief summary
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).
Detailed description
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.
Interventions
DEVICERocketAP
Artificial pancreas system which is designed to be able to identify when you have eaten and provide insulin for this meal
DEVICEUSS Virginia
Artificial pancreas system which responds to glucose fluctuations by modulating insulin delivery but does not specifically detect meal ingestion
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
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)
Eligibility
Sex/Gender
ALL
Age
12 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥12.0 and ≤25 years old at time of consent 2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year 3. Currently using insulin for at least six months 4. Currently using insulin pump for at least three months 5. Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections 6. Access to internet and willingness to upload data during the study as needed 7. For females, not currently known to be pregnant or breastfeeding 8. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued. 9. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use 10. Willingness to use the UVa artificial pancreas system throughout study sessions. 11. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study 12. Total daily insulin dose (TDD) at least 10 U/day and not more than 100 U/d 13. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals) 14. Willingness to eat at least 1 g/kg of carbohydrate per day during the camp/hotel admission 15. Willingness to reschedule Study Dinner Sessions if placed on oral steroids 16. An understanding and willingness to follow the protocol and signed informed consent
Exclusion criteria
1. History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment 2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment 3. Pregnancy or intent to become pregnant during the trial 4. Currently being treated for a seizure disorder 5. Planned surgery during study duration 6. Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals) 7. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol. 8. Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range 70-180 mg/dL in the Unannounced Meal | 6 hours | Percentage of time from dinner time until midnight with blood glucose in range 70-180 mg/dL in the unannounced meal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 \< 70 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 \>180 mg/dL |
| Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >250 mg/dL | 6 hours | Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range \>250 mg/dL |
| Units of Insulin Injected From Dinner Time Until Midnight | 6 hours | Units of insulin injected from dinner time until midnight |
| The Blood Glucose Area Under the Curve (AUC) From Dinner Until Midnight, Accounting for the Initial Blood Glucose Value | 6 hours | The blood glucose area under the curve (AUC) from dinner until midnight, accounting for the initial blood glucose value. |
| Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range 70-180 mg/dL | 12 hours | Percentage of time from dinner time until dinner time + 12h with blood glucose in range 70-180 mg/dL |
| Number of Hypoglycemia Events From Dinner Time Until Dinner Time + 12h | 12 hours | Number of hypoglycemia events from dinner Time until dinner time + 12h |
| 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 in range \<70 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 \>180 mg/dL |
| Number of Hypoglycemia Events From Dinner Time Until Midnight | 6 hours | Number of hypoglycemia events from dinner time until midnight |
| Units of Insulin Injected From Dinner Time Until Dinner Time + 12h | 12 hours | Units of insulin injected from dinner time until dinner time + 12h |
| The Blood Glucose Area Under the Curve (AUC) From Dinner Until Dinner + 12h, Accounting for the Initial Blood Glucose Value | 12 hours | The Blood Glucose Area Under the Curve (AUC) From Dinner Until dinner + 12h, Accounting for the Initial Blood Glucose Value |
| Percentage of Time Outside the Dinner Sessions With Blood Glucose in Range 70-180 mg/dL | 36 hours | Percentage of Time outside the dinner sessions With Blood Glucose in Range 70-180 mg/dL |
| Number of Hypoglycemia Events Outside of the Study Dinner Sessions | 36 hours | Number of hypoglycemia events outside of the Study Dinner Sessions |
| Percentage of Time Outside of the Study Dinner Sessions With Blood Glucose <70 mg/dL | 36 hours | Percentage of Time outside of the Study Dinner Sessions with Blood Glucose \<70 mg/dL |
| Percent of Time Outside of the Study Dinner Sessions With Blood Glucose >180 mg/dL | 36 hours | Percent of Time Outside of the Study Dinner Sessions with Blood Glucose \>180 mg/dL |
| Percent Time Outside of the Study Dinner Sessions With Blood Glucose >250 mg/dL | 36 hours | Percent Time Outside of the Study Dinner Sessions with Blood Glucose \>250 mg/dL |
| Units of Insulin Injected Outside of the Study Dinner Sessions | 36 hours | Units of insulin injected outside of the Study Dinner Sessions |
| Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >250 mg/dL | 12 hours | Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose \>250 mg/dL |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 9 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | tested positive for SARS-co-V2 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | USS Virginia First, Then Rocket AP | Total | RocketAP First, Then USS Virginia |
|---|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 17 Participants | 9 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Continuous | 16 years STANDARD_DEVIATION 2 | 16 years STANDARD_DEVIATION 1.7 | 15 years STANDARD_DEVIATION 1.4 |
| basal rate profile | 1.3 IU/h STANDARD_DEVIATION 0.4 | 1.3 IU/h STANDARD_DEVIATION 0.4 | 1.3 IU/h STANDARD_DEVIATION 0.4 |
| Carbohydrate ratio | 7.7 g CHO per IU of insulin STANDARD_DEVIATION 1.9 | 7.7 g CHO per IU of insulin STANDARD_DEVIATION 1.9 | 7.7 g CHO per IU of insulin STANDARD_DEVIATION 1.9 |
| Correction factor | 43 mg/dL glucose per IU insulin STANDARD_DEVIATION 18 | 43 mg/dL glucose per IU insulin STANDARD_DEVIATION 18 | 43 mg/dL glucose per IU insulin STANDARD_DEVIATION 18 |
| Duration of diabetes | 7.7 years STANDARD_DEVIATION 3.2 | 7.7 years STANDARD_DEVIATION 3.2 | 7.7 years STANDARD_DEVIATION 3.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 16 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| HbA1c | 7.3 % of HbA1c STANDARD_DEVIATION 1 | 7.4 % of HbA1c STANDARD_DEVIATION 1.5 | 7.7 % of HbA1c STANDARD_DEVIATION 2 |
| Height | 167 cm STANDARD_DEVIATION 9 | 167 cm STANDARD_DEVIATION 9 | 167 cm STANDARD_DEVIATION 9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 9 Participants | 17 Participants | 8 Participants |
| Region of Enrollment United States | 9 participants | 36 participants | 9 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 5 Participants |
| Total daily insulin | 60 IU STANDARD_DEVIATION 16.3 | 60 IU STANDARD_DEVIATION 16.3 | 60 IU STANDARD_DEVIATION 16.3 |
| Weight | 65.2 kg STANDARD_DEVIATION 11.5 | 65.2 kg STANDARD_DEVIATION 11.5 | 65.2 kg STANDARD_DEVIATION 11.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
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
Time frame: 6 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RocketAP | Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range 70-180 mg/dL in the Unannounced Meal | 83 %Time in Range (TIR) |
| USS Virginia | Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range 70-180 mg/dL in the Unannounced Meal | 53 %Time in Range (TIR) |
p-value: 0.004Wilcoxon (Mann-Whitney)
Secondary
Number of Hypoglycemia Events From Dinner Time Until Dinner Time + 12h
Number of hypoglycemia events from dinner Time until dinner time + 12h
Time frame: 12 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RocketAP | Number of Hypoglycemia Events From Dinner Time Until Dinner Time + 12h | 0 hypoglycemic event |
| USS Virginia | Number of Hypoglycemia Events From Dinner Time Until Dinner Time + 12h | 0 hypoglycemic event |
p-value: 0.41Wilcoxon (Mann-Whitney)
Secondary
Number of Hypoglycemia Events From Dinner Time Until Midnight
Number of hypoglycemia events from dinner time until midnight
Time frame: 6 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RocketAP | Number of Hypoglycemia Events From Dinner Time Until Midnight | 0 hypoglycemic event |
| USS Virginia | Number of Hypoglycemia Events From Dinner Time Until Midnight | 0 hypoglycemic event |
p-value: 0.26Wilcoxon (Mann-Whitney)
Secondary
Number of Hypoglycemia Events Outside of the Study Dinner Sessions
Number of hypoglycemia events outside of the Study Dinner Sessions
Time frame: 36 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RocketAP | Number of Hypoglycemia Events Outside of the Study Dinner Sessions | 3 hypoglycemic event |
| USS Virginia | Number of Hypoglycemia Events Outside of the Study Dinner Sessions | 4.5 hypoglycemic event |
p-value: 0.14Wilcoxon (Mann-Whitney)
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
Time frame: 12 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RocketAP | Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >180 mg/dL | 8.7 % time>180mg/dL |
| USS Virginia | Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >180 mg/dL | 25 % time>180mg/dL |
p-value: 0.003Wilcoxon (Mann-Whitney)
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
Time frame: 12 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RocketAP | Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >250 mg/dL | 0 % time>250mg/dL |
| USS Virginia | Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >250 mg/dL | 0 % time>250mg/dL |
p-value: 0.52Wilcoxon (Mann-Whitney)
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
Time frame: 12 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RocketAP | Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range 70-180 mg/dL | 90 %Time in Range (TIR) |
| USS Virginia | Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range 70-180 mg/dL | 75 %Time in Range (TIR) |
p-value: <0.001Wilcoxon (Mann-Whitney)
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
Time frame: 12 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RocketAP | Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range <70 mg/dL | 0 % time<70mg/dL |
| USS Virginia | Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range <70 mg/dL | 0 % time<70mg/dL |
p-value: 0.54Wilcoxon (Mann-Whitney)
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
Time frame: 6 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RocketAP | Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >180 mg/dL | 17 % time>180mg/dL |
| USS Virginia | Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >180 mg/dL | 47 % time>180mg/dL |
p-value: 0.01Wilcoxon (Mann-Whitney)
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
Time frame: 6 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RocketAP | Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >250 mg/dL | 0 % time>250mg/dL |
| USS Virginia | Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >250 mg/dL | 0 % time>250mg/dL |
p-value: 1Wilcoxon (Mann-Whitney)
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
Time frame: 6 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RocketAP | Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range < 70 mg/dL | 0 % time<70mg/dL |
| USS Virginia | Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range < 70 mg/dL | 0 % time<70mg/dL |
p-value: 0.2Wilcoxon (Mann-Whitney)
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
Time frame: 36 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RocketAP | Percentage of Time Outside of the Study Dinner Sessions With Blood Glucose <70 mg/dL | 2.2 % time<70mg/dL |
| USS Virginia | Percentage of Time Outside of the Study Dinner Sessions With Blood Glucose <70 mg/dL | 2.9 % time<70mg/dL |
p-value: 0.22Wilcoxon (Mann-Whitney)
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
Time frame: 36 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RocketAP | Percentage of Time Outside the Dinner Sessions With Blood Glucose in Range 70-180 mg/dL | 86 %Time in Range (TIR) |
| USS Virginia | Percentage of Time Outside the Dinner Sessions With Blood Glucose in Range 70-180 mg/dL | 81 %Time in Range (TIR) |
p-value: 0.007Wilcoxon (Mann-Whitney)
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
Time frame: 36 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RocketAP | Percent of Time Outside of the Study Dinner Sessions With Blood Glucose >180 mg/dL | 9.5 % time>180mg/dL |
| USS Virginia | Percent of Time Outside of the Study Dinner Sessions With Blood Glucose >180 mg/dL | 14 % time>180mg/dL |
p-value: 0.03Wilcoxon (Mann-Whitney)
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
Time frame: 36 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RocketAP | Percent Time Outside of the Study Dinner Sessions With Blood Glucose >250 mg/dL | 0 % time>250mg/dL |
| USS Virginia | Percent Time Outside of the Study Dinner Sessions With Blood Glucose >250 mg/dL | 0 % time>250mg/dL |
p-value: 0.49Wilcoxon (Mann-Whitney)
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
Time frame: 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RocketAP | The Blood Glucose Area Under the Curve (AUC) From Dinner Until Dinner + 12h, Accounting for the Initial Blood Glucose Value | 38891 mg/dL * min | Standard Deviation 16054 |
| USS Virginia | The Blood Glucose Area Under the Curve (AUC) From Dinner Until Dinner + 12h, Accounting for the Initial Blood Glucose Value | 40671 mg/dL * min | Standard Deviation 18110 |
p-value: 0.05t-test, 1 sided
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.
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RocketAP | The Blood Glucose Area Under the Curve (AUC) From Dinner Until Midnight, Accounting for the Initial Blood Glucose Value | 27052 mg/dL * min | Standard Deviation 1248 |
| USS Virginia | The Blood Glucose Area Under the Curve (AUC) From Dinner Until Midnight, Accounting for the Initial Blood Glucose Value | 25840 mg/dL * min | Standard Deviation 8134 |
p-value: 0.05t-test, 2 sided
Secondary
Units of Insulin Injected From Dinner Time Until Dinner Time + 12h
Units of insulin injected from dinner time until dinner time + 12h
Time frame: 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RocketAP | Units of Insulin Injected From Dinner Time Until Dinner Time + 12h | 21 IU | Standard Deviation 8 |
| USS Virginia | Units of Insulin Injected From Dinner Time Until Dinner Time + 12h | 20 IU | Standard Deviation 4 |
p-value: 0.28t-test, 2 sided
Secondary
Units of Insulin Injected From Dinner Time Until Midnight
Units of insulin injected from dinner time until midnight
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RocketAP | Units of Insulin Injected From Dinner Time Until Midnight | 15 IU of insulin | Standard Deviation 5 |
| USS Virginia | Units of Insulin Injected From Dinner Time Until Midnight | 14 IU of insulin | Standard Deviation 4 |
p-value: 0.21t-test, 2 sided
Secondary
Units of Insulin Injected Outside of the Study Dinner Sessions
Units of insulin injected outside of the Study Dinner Sessions
Time frame: 36 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RocketAP | Units of Insulin Injected Outside of the Study Dinner Sessions | 78 IU of insulin | Standard Deviation 23 |
| USS Virginia | Units of Insulin Injected Outside of the Study Dinner Sessions | 85 IU of insulin | Standard Deviation 20 |
p-value: 0.01t-test, 2 sided