Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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 in Pregnancy Associated With Type 1 Diabetes

Conditions
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Diabetes Mellitus, Type I

Intervention / Treatment
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* Device: Dexcom G4 or G5 Platinum CGM system
* Device: Dexcom G4 or G5 Platinum CGM system with Share


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine Care<br>Standard of Care in the Pregnancy and Women's Health clinic. | |
| Active Comparator: Dexcom G4 Platinum CGM system<br>An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy. | Device: Dexcom G4 or G5 Platinum CGM system<br>* Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy<br>|
| Active Comparator: Dexcom G4 Platinum CGM system with Share™<br>A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy. | Device: Dexcom G4 or G5 Platinum CGM system with Share<br>* Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Glucose Variability | Glucose variability as measured by glucose excursions from CGM | From first pregnancy visit to delivery | 
| Change(s) in Behavior and/or Concerns of Diabetics. | 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. | From first pregnancy visit to delivery | 

Secondary Outcome Measures

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