Trial Outcomes & Findings for Automated Insulin Delivery in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home (NCT NCT04492566)

NCT ID: NCT04492566

Last Updated: 2023-08-04

Results Overview

Time in target glucose range 63-140 mg/dL measured by CGM to determine safety and efficacy of the integrated system

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use
• Results posted on: 2023-08-04

Participant Flow

Participant milestones

Measure	AID Evaluation After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Automated Insulin Delivery in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home

Baseline characteristics by cohort

Measure	AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	32.6 years STANDARD_DEVIATION 4.3 • n=93 Participants
Sex: Female, Male Female	10 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	10 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	10 participants n=93 Participants
Glycated Hemoglobin	5.8 percentage of glycated hemoglobin STANDARD_DEVIATION 0.6 • n=93 Participants

PRIMARY outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Time in target glucose range 63-140 mg/dL measured by CGM to determine safety and efficacy of the integrated system

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Time in Target Glucose Range

78.6 percent time Standard Deviation 9.2

SECONDARY outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Sensor glucose time within the target range of 63-140 mg/dl overnight

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Overnight Time in Target Glucose Range

84.8 percent time Standard Deviation 7.7

SECONDARY outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Sensor glucose time within the target range of 63-140 mg/dl postprandially within 2 hours following meals and 2 hours following meals

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Postprandial Time in Target Glucose Range

73.4 percent time Standard Deviation 11

SECONDARY outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Percent time CGM glucose < 63 mg/dL

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Glucose < 63 mg/dL

1.6 percent time Interval 1.4 to 2.1

SECONDARY outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Percent time CGM glucose < 54 mg/dL

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Glucose < 54 mg/dL

0.4 percent time Interval 0.3 to 0.4

SECONDARY outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Percent time GGM glucose > 140 mg/dL

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Glucose > 140 mg/dL

19.7 percent time Standard Deviation 9.5

SECONDARY outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Percent time GGM glucose > 180 mg/dL

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Glucose > 180 mg/dL

3.4 percent time Interval 3.0 to 8.0

SECONDARY outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Number of hypoglycemic events per week, defined as time <54 mg/dL for 15 consecutive minutes followed by time >70 mg/dL for 15 consecutive minutes.

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Hypoglycemic Events Per Week

0.7 events per week Standard Deviation 0.6

SECONDARY outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Number of hypoglycemic events that events that require active assistance of another individual

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Severe Hypoglycemic Events

0 Number of Events Standard Deviation 0

SECONDARY outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Number of episodes with ketones >1 mmol/L

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Hyperglycemic Events

0.2 Number of Events Standard Deviation 0.42

SECONDARY outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Percent time GGM glucose > 250 mg/dL

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Glucose > 250 mg/dL

0.2 percent time Interval 0.1 to 0.6

SECONDARY outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

The total number of serious adverse events during the clinical trial

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Serious Adverse Events (SAE)

0 Events

SECONDARY outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

The total number of serious adverse events related to the study device use during the clinical trial

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Serious Adverse Device Events (SADE)

0 Events

SECONDARY outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Population: Infusion Set Failure

The total number of adverse device effects (ADE) during the clinical trial

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Adverse Device Effects (ADE)

2 Events

SECONDARY outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

The total number of unanticipated adverse device effects (UADE) during the clinical trial

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Unanticipated Adverse Device Effects (UADE)

0 Events

SECONDARY outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Mean CGM glucose level during AID use

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Mean CGM Glucose Level

115.1 mg/dL Standard Deviation 10.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Percent time (hours/day) of closed-loop use during the clinical trial

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Closed-Loop Active Time

94.1 percent time Standard Deviation 4.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Percent Time CGM during the clinical trial

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Sensor Use Time

98.5 percent time Standard Deviation 0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Number of subjects who develop gestational hypertension during pregnancy

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Maternal Outcomes: Gestational Hypertension

1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Number of subjects who develop pre-eclampsia during pregnancy

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Maternal Outcomes: Pre-eclampsia

0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Number of subjects who develop eclampsia during pregnancy

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Maternal Outcomes: Eclampsia

0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Number of subjects who develop oligo/polyhydramnios during pregnancy

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Maternal Outcomes: Oligo/Polyhydramnios

0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Number of subjects who develop pre term labor during pregnancy

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Maternal Outcomes: Pre Term Labor

0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of iAPS Use During Pregnancy up to 40 weeks of Use

Number of subjects who underwent primary caesarian section

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Maternal Outcomes: Primary Caesarian Section

3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At Delivery

Number of infants born large for gestational age

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Fetal Outcomes: Large for Gestational Age

3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At delivery and up to 48 hours afterwards

Population: No IV glucose was given, all treated with glucose gel.

Number of infants who develop neonatal hypoglycemia. Neonatal hypoglycemia is defined as treatment requiring IV dextrose, treatment of the newborn with glucose gel is also reported, however protocols for use of glucose gel varied by delivery location.

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Fetal Outcomes: Neonatal Hypoglycemia

3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At delivery and up to 7 days afterwards

Number of infants who are admitted to the neonatal intensive care unit

Outcome measures

Measure

AID Evaluation n=10 Participants After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Fetal Outcomes: Neonatal Intensive Care Unit Admission

1 Participants

Adverse Events

AID Evaluation

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	AID Evaluation n=10 participants at risk After completing a 1-2 week CGM run-in period, subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy. Automated Insulin Delivery: Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.
Endocrine disorders ketosis	20.0% 2/10 • Number of events 2 • Pregnancy through delivery, up to 40 weeks.
Infections and infestations COVID-19	20.0% 2/10 • Number of events 2 • Pregnancy through delivery, up to 40 weeks.
Pregnancy, puerperium and perinatal conditions gestational hypertension	10.0% 1/10 • Number of events 1 • Pregnancy through delivery, up to 40 weeks.
Pregnancy, puerperium and perinatal conditions exacerbation of pre-pregnancy hypertension	10.0% 1/10 • Number of events 1 • Pregnancy through delivery, up to 40 weeks.

Additional Information

Dr. Kristin Castorino

Sansum Diabetes Research Institute

Phone: 805-682-7638

Email: info@sansum.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place