Trial Outcomes & Findings for Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy (NCT NCT03761615)

Results Overview

Time in range defined as 63-140 mg/dL as determined by CGM analysis

Recruitment status

COMPLETED

Target enrollment

25 participants

Primary outcome timeframe

Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

Results posted on

2024-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	Type 1 Diabetes and Pregnancy Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Type 1 Diabetes and Pregnancy n=25 Participants Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	30.2 years STANDARD_DEVIATION 4.8 • n=93 Participants
Sex: Female, Male Female	25 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 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	24 Participants n=93 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	25 participants n=93 Participants
Gestational Age at Enrollment	11.2 weeks STANDARD_DEVIATION 3.9 • n=93 Participants

PRIMARY outcome

Timeframe: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

Time in range defined as 63-140 mg/dL as determined by CGM analysis

Outcome measures

Outcome measures
Measure	Type 1 Diabetes and Pregnancy n=25 Participants Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Percentage of Time in Range Glucose Levels 63-140 mg/dL as Determined by CGM	59 percentage of time Standard Deviation 14

SECONDARY outcome

Timeframe: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

Time spent below target cgm glucose range defined as glucose \<63 mg/dL

Outcome measures

Outcome measures
Measure	Type 1 Diabetes and Pregnancy n=25 Participants Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Percentage of Percentage of Time Spent Below Target Glucose (<63 mg/dL) as Determined by CGM	3 percentage of time Standard Deviation 3

SECONDARY outcome

Timeframe: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

Time spent above target cgm glucose range defined as \>140 mg/dL

Outcome measures

Outcome measures
Measure	Type 1 Diabetes and Pregnancy n=25 Participants Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Percentage of Time Spent Above Target Glucose Range (> 140 mg/dL) as Determined by CGM	38 percentage of time Standard Deviation 15

SECONDARY outcome

Timeframe: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

Episodes of clinically significant hyperglycemia with CGM glucose \>180 mg/dL

Outcome measures

Outcome measures
Measure	Type 1 Diabetes and Pregnancy n=25 Participants Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Episodes of Clinically Significant Hyperglycemia	0.08 episodes Standard Deviation 0.28

SECONDARY outcome

Timeframe: 2 weeks

Total daily insulin requirements (units/kg/day) over last 2 weeks of third trimester

Outcome measures

Outcome measures
Measure	Type 1 Diabetes and Pregnancy n=25 Participants Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Total Daily Insulin Requirements Over Last 2 Weeks of Third Trimester	0.88 units/kg/day Standard Deviation 0.04

SECONDARY outcome

Timeframe: 2 weeks

Basal daily insulin requirements (units/kg/day) over last 2 weeks of third trimester

Outcome measures

Outcome measures
Measure	Type 1 Diabetes and Pregnancy n=25 Participants Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Basal Insulin Requirements Over Last 2 Weeks of Third Trimester	0.4 units/kg/day Standard Deviation 0.03

SECONDARY outcome

Timeframe: 2 weeks

Carbohydrate consumption (g/(kg\*day)) over last 2 weeks of third trimester

Outcome measures

Outcome measures
Measure	Type 1 Diabetes and Pregnancy n=25 Participants Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Carbohydrate Consumption Over Last 2 Weeks of Third Trimester	1.76 g/(kg*day) Standard Deviation 0.11

OTHER_PRE_SPECIFIED outcome

Timeframe: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

Episodes of ketoacidosis requiring emergency room or hospital admission

Outcome measures

Outcome measures
Measure	Type 1 Diabetes and Pregnancy n=25 Participants Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Ketoacidosis	0.0 events during pregnancy Standard Deviation 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

Maternal complications including preeclampsia, pregnancy induced hypertension and polyhydramnios

Outcome measures

Outcome measures
Measure	Type 1 Diabetes and Pregnancy n=25 Participants Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Maternal Complications	0.36 complications Standard Deviation 0.49

OTHER_PRE_SPECIFIED outcome

Timeframe: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

Gestational weight gain each week

Outcome measures

Outcome measures
Measure	Type 1 Diabetes and Pregnancy n=25 Participants Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Gestational Weight Gain	0.42 kg/week Standard Deviation 0.14

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately at birth

Gestational age at delivery (Weeks)

Outcome measures

Outcome measures
Measure	Type 1 Diabetes and Pregnancy n=25 Participants Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Gestational Age at Delivery	37.7 weeks Standard Deviation 1.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately at birth

Birth weight of baby (kg)

Outcome measures

Outcome measures
Measure	Type 1 Diabetes and Pregnancy n=25 Participants Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Birth Weight of Baby	3700 grams Interval 2135.0 to 4345.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately at birth

Population: Infants delivered

Number of Large for Gestational Age based on WHO criteria at time of delivery

Outcome measures

Outcome measures
Measure	Type 1 Diabetes and Pregnancy n=25 Participants Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
LGA	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately at birth

Population: Number of infants delivered preterm late preterm (at 34-37 weeks).

Number of infants born late preterm birth (at 34-37 weeks)

Outcome measures

Outcome measures
Measure	Type 1 Diabetes and Pregnancy n=25 Participants Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Preterm Birth	8 infants

OTHER_PRE_SPECIFIED outcome

Timeframe: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

Population: Number of infants admitted to NICU

Number of infants requiring neonatal NICU stay

Outcome measures

Outcome measures
Measure	Type 1 Diabetes and Pregnancy n=25 Participants Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Neonatal NICU Stay	10 infants

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately at birth

Number of participants that underwent primary cesarean section for delivery

Outcome measures

Outcome measures
Measure	Type 1 Diabetes and Pregnancy n=25 Participants Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Cesarean Delivery	13 Participants

Adverse Events

Type 1 Diabetes and Pregnancy

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Type 1 Diabetes and Pregnancy n=25 participants at risk Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Endocrine disorders Severe Hypoglycemia	8.0% 2/25 • Number of events 2 • During pregnancy, up to 39 weeks

Other adverse events

Other adverse events
Measure	Type 1 Diabetes and Pregnancy n=25 participants at risk Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes. Dexcom G6 CGM: All women in the study will be given Dexcom G6 CGM and a study glucometer.
Pregnancy, puerperium and perinatal conditions gestational hypertension	8.0% 2/25 • Number of events 2 • During pregnancy, up to 39 weeks
Pregnancy, puerperium and perinatal conditions Preeclampsia	20.0% 5/25 • Number of events 5 • During pregnancy, up to 39 weeks
Pregnancy, puerperium and perinatal conditions Polyhydramnios	8.0% 2/25 • Number of events 2 • During pregnancy, up to 39 weeks

Additional Information

Dr. Kristin Castorino

Sansum Diabetes Research Institute

Phone: 805-682-7638

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place