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.
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.
Study Type
OBSERVATIONAL
Enrollment
25
All women in the study will be given Dexcom G6 CGM and a study glucometer.
Sansum Diabetes Research Institute
Santa Barbara, California, United States
Mayo Clinic
Rochester, Minnesota, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
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
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
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
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
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
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
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
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