Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type I

In brief

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.

Key facts

Study ID

NCT02556554

Run by

University of Colorado, Denver

People needed

67

Starts

2015-08-01

Expected to finish

2017-08-01

Last updated by the study team

2020-07-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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