Trial Outcomes & Findings for Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes (NCT NCT04545567)

Results Overview

Percentage of time from dinner time until midnight with blood glucose in range 70-180 mg/dL in the unannounced meal

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

6 hours

Results posted on

2022-04-20

Participant Flow

21 subjects were recruited from October 2020 to mid-December 2020 either in person (UVA CDT facility) or by video conference.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	10	11
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study tested positive for SARS-co-V2	1	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6 hours

Percentage of time from dinner time until midnight with blood glucose in range 70-180 mg/dL in the unannounced meal

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
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) Interval 64.0 to 93.0	53 %Time in Range (TIR) Interval 40.0 to 71.0

SECONDARY outcome

Timeframe: 6 hours

Number of hypoglycemia events from dinner time until midnight

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
Number of Hypoglycemia Events From Dinner Time Until Midnight	0 hypoglycemic event Interval 0.0 to 0.0	0 hypoglycemic event Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 6 hours

Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range \< 70 mg/dL

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range < 70 mg/dL	0 % time<70mg/dL Interval 0.0 to 1.0	0 % time<70mg/dL Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 6 hours

Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range \>180 mg/dL

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >180 mg/dL	17 % time>180mg/dL Interval 1.3 to 34.0	47 % time>180mg/dL Interval 28.0 to 60.0

SECONDARY outcome

Timeframe: 6 hours

Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range \>250 mg/dL

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >250 mg/dL	0 % time>250mg/dL Interval 0.0 to 0.0	0 % time>250mg/dL Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 6 hours

Units of insulin injected from dinner time until midnight

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
Units of Insulin Injected From Dinner Time Until Midnight	15 IU of insulin Standard Deviation 5	14 IU of insulin Standard Deviation 4

SECONDARY outcome

Timeframe: 6 hours

The blood glucose area under the curve (AUC) from dinner until midnight, accounting for the initial blood glucose value.

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
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	25840 mg/dL * min Standard Deviation 8134

SECONDARY outcome

Timeframe: 12 hours

Percentage of time from dinner time until dinner time + 12h with blood glucose in range 70-180 mg/dL

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range 70-180 mg/dL	90 %Time in Range (TIR) Interval 79.0 to 96.0	75 %Time in Range (TIR) Interval 58.0 to 83.0

SECONDARY outcome

Timeframe: 12 hours

Number of hypoglycemia events from dinner Time until dinner time + 12h

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
Number of Hypoglycemia Events From Dinner Time Until Dinner Time + 12h	0 hypoglycemic event Interval 0.0 to 0.7	0 hypoglycemic event Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 12 hours

Percentage of time from dinner time until dinner time + 12h with blood Glucose in range \<70 mg/dL

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range <70 mg/dL	0 % time<70mg/dL Interval 0.0 to 1.2	0 % time<70mg/dL Interval 0.0 to 0.7

SECONDARY outcome

Timeframe: 12 hours

Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose \>180 mg/dL

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >180 mg/dL	8.7 % time>180mg/dL Interval 3.0 to 17.0	25 % time>180mg/dL Interval 14.0 to 37.0

SECONDARY outcome

Timeframe: 12 hours

Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose \>250 mg/dL

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >250 mg/dL	0 % time>250mg/dL Interval 0.0 to 0.0	0 % time>250mg/dL Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 12 hours

Units of insulin injected from dinner time until dinner time + 12h

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
Units of Insulin Injected From Dinner Time Until Dinner Time + 12h	21 IU Standard Deviation 8	20 IU Standard Deviation 4

SECONDARY outcome

Timeframe: 12 hours

The Blood Glucose Area Under the Curve (AUC) From Dinner Until dinner + 12h, Accounting for the Initial Blood Glucose Value

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
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	40671 mg/dL * min Standard Deviation 18110

SECONDARY outcome

Timeframe: 36 hours

Percentage of Time outside the dinner sessions With Blood Glucose in Range 70-180 mg/dL

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
Percentage of Time Outside the Dinner Sessions With Blood Glucose in Range 70-180 mg/dL	86 %Time in Range (TIR) Interval 82.0 to 92.0	81 %Time in Range (TIR) Interval 76.0 to 86.0

SECONDARY outcome

Timeframe: 36 hours

Number of hypoglycemia events outside of the Study Dinner Sessions

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
Number of Hypoglycemia Events Outside of the Study Dinner Sessions	3 hypoglycemic event Interval 1.0 to 5.0	4.5 hypoglycemic event Interval 1.0 to 8.0

SECONDARY outcome

Timeframe: 36 hours

Percentage of Time outside of the Study Dinner Sessions with Blood Glucose \<70 mg/dL

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
Percentage of Time Outside of the Study Dinner Sessions With Blood Glucose <70 mg/dL	2.2 % time<70mg/dL Interval 1.0 to 3.6	2.9 % time<70mg/dL Interval 0.9 to 4.8

SECONDARY outcome

Timeframe: 36 hours

Percent of Time Outside of the Study Dinner Sessions with Blood Glucose \>180 mg/dL

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
Percent of Time Outside of the Study Dinner Sessions With Blood Glucose >180 mg/dL	9.5 % time>180mg/dL Interval 5.0 to 13.0	14 % time>180mg/dL Interval 7.0 to 18.0

SECONDARY outcome

Timeframe: 36 hours

Percent Time Outside of the Study Dinner Sessions with Blood Glucose \>250 mg/dL

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
Percent Time Outside of the Study Dinner Sessions With Blood Glucose >250 mg/dL	0 % time>250mg/dL Interval 0.0 to 1.0	0 % time>250mg/dL Interval 0.0 to 1.5

SECONDARY outcome

Timeframe: 36 hours

Units of insulin injected outside of the Study Dinner Sessions

Outcome measures

Outcome measures
Measure	RocketAP n=18 Participants 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.	USS Virginia n=18 Participants 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.
Units of Insulin Injected Outside of the Study Dinner Sessions	78 IU of insulin Standard Deviation 23	85 IU of insulin Standard Deviation 20

Adverse Events

RocketAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

USS Virginia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark DeBoer

University of Virginia

Phone: 1 434 924 0123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	RocketAP First, Then USS Virginia n=9 Participants 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.	USS Virginia First, Then Rocket AP n=9 Participants 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 n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	15 years STANDARD_DEVIATION 1.4 • n=5 Participants	16 years STANDARD_DEVIATION 2 • n=7 Participants	16 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	36 participants n=5 Participants
HbA1c	7.7 % of HbA1c STANDARD_DEVIATION 2 • n=5 Participants	7.3 % of HbA1c STANDARD_DEVIATION 1 • n=7 Participants	7.4 % of HbA1c STANDARD_DEVIATION 1.5 • n=5 Participants
Weight	65.2 kg STANDARD_DEVIATION 11.5 • n=5 Participants	65.2 kg STANDARD_DEVIATION 11.5 • n=7 Participants	65.2 kg STANDARD_DEVIATION 11.5 • n=5 Participants
Height	167 cm STANDARD_DEVIATION 9 • n=5 Participants	167 cm STANDARD_DEVIATION 9 • n=7 Participants	167 cm STANDARD_DEVIATION 9 • n=5 Participants
Duration of diabetes	7.7 years STANDARD_DEVIATION 3.2 • n=5 Participants	7.7 years STANDARD_DEVIATION 3.2 • n=7 Participants	7.7 years STANDARD_DEVIATION 3.2 • n=5 Participants
Total daily insulin	60 IU STANDARD_DEVIATION 16.3 • n=5 Participants	60 IU STANDARD_DEVIATION 16.3 • n=7 Participants	60 IU STANDARD_DEVIATION 16.3 • n=5 Participants
Carbohydrate ratio	7.7 g CHO per IU of insulin STANDARD_DEVIATION 1.9 • n=5 Participants	7.7 g CHO per IU of insulin STANDARD_DEVIATION 1.9 • n=7 Participants	7.7 g CHO per IU of insulin STANDARD_DEVIATION 1.9 • n=5 Participants
Correction factor	43 mg/dL glucose per IU insulin STANDARD_DEVIATION 18 • n=5 Participants	43 mg/dL glucose per IU insulin STANDARD_DEVIATION 18 • n=7 Participants	43 mg/dL glucose per IU insulin STANDARD_DEVIATION 18 • n=5 Participants
basal rate profile	1.3 IU/h STANDARD_DEVIATION 0.4 • n=5 Participants	1.3 IU/h STANDARD_DEVIATION 0.4 • n=7 Participants	1.3 IU/h STANDARD_DEVIATION 0.4 • n=5 Participants