Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy

University of Colorado, Denver67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type I

Interventions

Dexcom G4 or G5 Platinum CGM systemDEVICE

Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy

Dexcom G4 or G5 Platinum CGM system with ShareDEVICE

Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Colorado

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Changes in Glucose Variability

Glucose variability as measured by glucose excursions from CGM

Time frame: 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.

Time frame: From first pregnancy visit to delivery

Secondary Outcomes

Change in A1C.

Change in A1C with CGM alone and CGM with Share™ compared to no CGM use.

Time frame: 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)

Time frame: From first pregnancy visit to delivery

Data from ClinicalTrials.gov

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