Pregnancy in Diabetics, Type 1 Diabetes Mellitus
Conditions
Keywords
type 1 diabetes, pregnancy, continues glucose monitoring, artificial pancreas
Brief summary
The overall goal of this study is to enroll pregnant women with type 1 diabetes and follow their glycemic outcomes prospectively throughout pregnancy and into the post-partum period. The investigators anticipate that when compared to subjects using an Artificial pancreas system (AP) as part of a future protocol, this comparator group of subjects undergoing usual care will exhibit less time in target continuous glucose monitoring (CGM) glucose range defined as 63-140 mg/dL and an increased duration of hypoglycemia with CGM glucose \<63 mg/dL.
Detailed description
This is an observational study. Data collected will include records of continuous glucose monitoring (CGM) based glucose, insulin delivery, self-monitoring of blood glucose (SMBG), and maternal and fetal outcomes from pregnant women with type 1 diabetes. These data will be used to: (1) develop and refine algorithms for an AP system tailored to the needs of pregnant women with type 1 diabetes, (2) to serve as a comparator group for concurrent AP protocols, (3) describe Dexcom G6 CGM data throughout the pregnancy, and (4) describe insulin changes which occur in pregnancy.
Interventions
DEVICEDexcom G6 CGM
All women in the study will be given Dexcom G6 CGM and a study glucometer.
Sponsors
Harvard University
Mayo Clinic
Icahn School of Medicine at Mount Sinai
Sansum Diabetes Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis, based on investigator assessment, of T1D for at least one year and using insulin for at least 1 year. * Criteria for documented hyperglycemia (at least 1 must be met): * Fasting glucose ≥126 mg/dL * Two-hour OGTT glucose ≥200 mg/dL * HbA1c ≥6.5% documented * Random glucose ≥200 mg/dL with symptoms * No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with T1D * Criteria for requiring insulin at diagnosis (1 must be met): * Participant required insulin at diagnosis and continually thereafter. * Participant did not start insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and did require insulin eventually and used continually. * Participant did not start insulin at diagnosis but continued to be hyperglycemic, had positive islet cell antibodies - consistent with latent autoimmune diabetes in adults (LADA) and did require insulin eventually and used continually. * Currently using an insulin pump for diabetes management * Currently using or willing to use an insulin-to-carbohydrate ratio to calculate meal bolus sizes * Willing to change insulin infusion site at least every 3 days. * Confirmed pregnancy * Current gestational age \<17 weeks * Age 18-40 years * HbA1c \<10.0% * Demonstration of proper mental status and cognition for the study * Ability to access the internet and upload CGM data remotely if needed * An understanding of and willingness to follow the protocol and sign the informed consent
Exclusion criteria
* 670 G users in Auto mode * Current gestational age ≥17 weeks * Cystic fibrosis * A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples: * Inpatient psychiatric treatment in the past 6 months * Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty * Active gastroparesis * Abuse of alcohol or recreational drugs * Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis) * Uncontrolled arterial hypertension (Resting diastolic blood pressure \>95mmHg and/or systolic blood pressure \>160 mmHg) at the time of screening * Chronic oral steroid use * A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time in Range Glucose Levels 63-140 mg/dL as Determined by CGM | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time Spent Above Target Glucose Range (> 140 mg/dL) as Determined by CGM | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum | Time spent above target cgm glucose range defined as \>140 mg/dL |
| Episodes of Clinically Significant Hyperglycemia | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum | Episodes of clinically significant hyperglycemia with CGM glucose \>180 mg/dL |
| Percentage of Percentage of Time Spent Below Target Glucose (<63 mg/dL) as Determined by CGM | 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 |
| Basal Insulin Requirements Over Last 2 Weeks of Third Trimester | 2 weeks | Basal daily insulin requirements (units/kg/day) over last 2 weeks of third trimester |
| Carbohydrate Consumption Over Last 2 Weeks of Third Trimester | 2 weeks | Carbohydrate consumption (g/(kg\*day)) over last 2 weeks of third trimester |
| Total Daily Insulin Requirements Over Last 2 Weeks of Third Trimester | 2 weeks | Total daily insulin requirements (units/kg/day) over last 2 weeks of third trimester |
Other
| Measure | Time frame | Description |
|---|---|---|
| Preterm Birth | Immediately at birth | Number of infants born late preterm birth (at 34-37 weeks) |
| Cesarean Delivery | Immediately at birth | Number of participants that underwent primary cesarean section for delivery |
| Neonatal NICU Stay | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum | Number of infants requiring neonatal NICU stay |
| Ketoacidosis | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum | Episodes of ketoacidosis requiring emergency room or hospital admission |
| Maternal Complications | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum | Maternal complications including preeclampsia, pregnancy induced hypertension and polyhydramnios |
| Gestational Weight Gain | Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum | Gestational weight gain each week |
| Gestational Age at Delivery | Immediately at birth | Gestational age at delivery (Weeks) |
| Birth Weight of Baby | Immediately at birth | Birth weight of baby (kg) |
| LGA | Immediately at birth | Number of Large for Gestational Age based on WHO criteria at time of delivery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Type 1 Diabetes and Pregnancy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age, Continuous | 30.2 years STANDARD_DEVIATION 4.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Gestational Age at Enrollment | 11.2 weeks STANDARD_DEVIATION 3.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 9 / 25 |
| serious Total, serious adverse events | 2 / 25 |
Outcome results
Primary
Percentage of Time in Range Glucose Levels 63-140 mg/dL as Determined by CGM
Time in range defined as 63-140 mg/dL as determined by CGM analysis
Time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Diabetes and Pregnancy | Percentage of Time in Range Glucose Levels 63-140 mg/dL as Determined by CGM | 59 percentage of time | Standard Deviation 14 |
Secondary
Basal Insulin Requirements Over Last 2 Weeks of Third Trimester
Basal daily insulin requirements (units/kg/day) over last 2 weeks of third trimester
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Diabetes and Pregnancy | Basal Insulin Requirements Over Last 2 Weeks of Third Trimester | 0.4 units/kg/day | Standard Deviation 0.03 |
Secondary
Carbohydrate Consumption Over Last 2 Weeks of Third Trimester
Carbohydrate consumption (g/(kg\*day)) over last 2 weeks of third trimester
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Diabetes and Pregnancy | Carbohydrate Consumption Over Last 2 Weeks of Third Trimester | 1.76 g/(kg*day) | Standard Deviation 0.11 |
Secondary
Episodes of Clinically Significant Hyperglycemia
Episodes of clinically significant hyperglycemia with CGM glucose \>180 mg/dL
Time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Diabetes and Pregnancy | Episodes of Clinically Significant Hyperglycemia | 0.08 episodes | Standard Deviation 0.28 |
Secondary
Percentage of Percentage of Time Spent Below Target Glucose (<63 mg/dL) as Determined by CGM
Time spent below target cgm glucose range defined as glucose \<63 mg/dL
Time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Diabetes and Pregnancy | Percentage of Percentage of Time Spent Below Target Glucose (<63 mg/dL) as Determined by CGM | 3 percentage of time | Standard Deviation 3 |
Secondary
Percentage of Time Spent Above Target Glucose Range (> 140 mg/dL) as Determined by CGM
Time spent above target cgm glucose range defined as \>140 mg/dL
Time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Diabetes and Pregnancy | Percentage of Time Spent Above Target Glucose Range (> 140 mg/dL) as Determined by CGM | 38 percentage of time | Standard Deviation 15 |
Secondary
Total Daily Insulin Requirements Over Last 2 Weeks of Third Trimester
Total daily insulin requirements (units/kg/day) over last 2 weeks of third trimester
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Diabetes and Pregnancy | Total Daily Insulin Requirements Over Last 2 Weeks of Third Trimester | 0.88 units/kg/day | Standard Deviation 0.04 |
Other Pre-specified
Birth Weight of Baby
Birth weight of baby (kg)
Time frame: Immediately at birth
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Type 1 Diabetes and Pregnancy | Birth Weight of Baby | 3700 grams |
Other Pre-specified
Cesarean Delivery
Number of participants that underwent primary cesarean section for delivery
Time frame: Immediately at birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Type 1 Diabetes and Pregnancy | Cesarean Delivery | 13 Participants |
Other Pre-specified
Gestational Age at Delivery
Gestational age at delivery (Weeks)
Time frame: Immediately at birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Diabetes and Pregnancy | Gestational Age at Delivery | 37.7 weeks | Standard Deviation 1.6 |
Other Pre-specified
Gestational Weight Gain
Gestational weight gain each week
Time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Diabetes and Pregnancy | Gestational Weight Gain | 0.42 kg/week | Standard Deviation 0.14 |
Other Pre-specified
Ketoacidosis
Episodes of ketoacidosis requiring emergency room or hospital admission
Time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Diabetes and Pregnancy | Ketoacidosis | 0.0 events during pregnancy | Standard Deviation 0 |
Other Pre-specified
LGA
Number of Large for Gestational Age based on WHO criteria at time of delivery
Time frame: Immediately at birth
Population: Infants delivered
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Type 1 Diabetes and Pregnancy | LGA | 14 Participants |
Other Pre-specified
Maternal Complications
Maternal complications including preeclampsia, pregnancy induced hypertension and polyhydramnios
Time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Diabetes and Pregnancy | Maternal Complications | 0.36 complications | Standard Deviation 0.49 |
Other Pre-specified
Neonatal NICU Stay
Number of infants requiring neonatal NICU stay
Time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
Population: Number of infants admitted to NICU
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Type 1 Diabetes and Pregnancy | Neonatal NICU Stay | 10 infants |
Other Pre-specified
Preterm Birth
Number of infants born late preterm birth (at 34-37 weeks)
Time frame: Immediately at birth
Population: Number of infants delivered preterm late preterm (at 34-37 weeks).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Type 1 Diabetes and Pregnancy | Preterm Birth | 8 infants |