Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy

Not Applicable

Completed

Interventions: Device: Dexcom G4 or G5 Platinum CGM system
Device: Dexcom G4 or G5 Platinum CGM system with Share

Brief Summary: A single-center, prospective, 'open-label,' investigator-initiated pilot study evaluating the role of continuous glucose monitor (CGM) use either alone or with remote monitoring capabilities during pregnancy associated with T1DM.

Detailed Description: A single-center, prospective, 'open-label,' investigator-initiated pilot study evaluating the role of continuous glucose monitor (CGM) use either alone or with remote monitoring capabilities that enable subjects to share CGM data with family and friends (whom the investigators will call "followers" in this protocol) among women with T1DM associated with pregnancy.

Recruitment & Eligibility

Inclusion Criteria

Signed informed consent before any study-related activities
Female aged 18 years and older
T1D duration >1 year
Pregnancy with confirmation of gestational age 13 weeks or less
Willingness to routinely practice at least 3-7 blood glucose measurements per day
Using MDI or CSII therapy
Willingness to provide an A1C level
Ability and willingness to adhere to the protocol including scheduled study visits for the duration of the pregnancy
Able to speak, read, and write English

Exclusion Criteria

Extensive skin changes/diseases that inhibit wearing a sensor on normal skin
Known allergy to adhesives
Any other condition, as determined by the investigator, which could make the subject unsuitable for the trial, impairs the subject's suitability for the trial, or impairs the validity of the informed consent

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Dexcom G4 Platinum CGM system	Dexcom G4 or G5 Platinum CGM system	An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.
Dexcom G4 Platinum CGM system with Share™	Dexcom G4 or G5 Platinum CGM system with Share	A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.

Primary Outcome Measures

Name	Time	Method
Changes in Glucose Variability	From first pregnancy visit to delivery	Glucose variability as measured by glucose excursions from CGM
Change(s) in Behavior and/or Concerns of Diabetics.	From first pregnancy visit to delivery	Change(s) in behavior and/or concerns of diabetics as detected by the hypoglycemia fear questionnaire. Behavior sub-scale score ranges from 10-50, with higher scores indicating more behavioral changes in the participant's daily routine to avoid low blood sugar. Worry sub-scale score ranges from 17-85, with higher scores indicating more worry or concerns because of low blood sugar. Total score ranges from 27-135, with higher scores for both sub-scales indicating more fear and a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Change in A1C.	From first pregnancy visit to delivery	Change in A1C with CGM alone and CGM with Share™ compared to no CGM use.
Evaluation of Maternal and Fetal Outcomes.	From first pregnancy visit to delivery	Evaluation of Maternal and fetal outcomes (eclampsia/pre-eclampsia, live birth rates, birth weight, neonatal hypoglycemia, and other similar measures)