Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Diabetes Mellitus, Type I

Treatments: Device: Dexcom G4 or G5 Platinum CGM system with Share; Device: Dexcom G4 or G5 Platinum CGM system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02556554

15-1006

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 67 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

67 participants in 3 patient groups

Routine Care

No Intervention group

Description:

Standard of Care in the Pregnancy and Women's Health clinic.

Dexcom G4 Platinum CGM system

Active Comparator group

Description:

An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.

Treatment:

Device: Dexcom G4 or G5 Platinum CGM system

Dexcom G4 Platinum CGM system with Share™

Active Comparator group

Description:

A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.

Treatment:

Device: Dexcom G4 or G5 Platinum CGM system with Share