Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy

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.

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