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Aurora, Colorado 80045


Purpose:

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.


Study 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 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.


Criteria:

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


NCT ID:

NCT02556554


Primary Contact:

Principal Investigator
Sarit Polsky, MD, MPH
University of Colorado, Denver


Backup Contact:

N/A


Location Contact:

Aurora, Colorado 80045
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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