Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy



Status:Active, not recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:10/13/2018
Start Date:September 2015
End Date:December 2018

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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

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.

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.

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
We found this trial at
1
site
Aurora, Colorado 80045
Principal Investigator: Sarit Polsky, MD, MPH
?
mi
from
Aurora, CO
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