Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type I

• Registration Number: NCT02556554
• Lead Sponsor: University of Colorado, Denver

Brief 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 during pregnancy associated with T1DM.

Detailed 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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-11
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-22
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Results First Submitted: 2019-05-13
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-07
• Last Update Submitted: 2020-07-07
• Results First Posted: 2020-07-21
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change(s) in Behavior and/or Concerns of Diabetics.	From first pregnancy visit to delivery	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.
Changes in Glucose Variability	From first pregnancy visit to delivery	Glucose variability as measured by glucose excursions from CGM

Secondary Outcome Measures

Name	Time	Method
Evaluation of Maternal and Fetal Outcomes.	From first pregnancy visit to delivery	Evaluation of Maternal and fetal outcomes (eclampsia/pre-eclampsia, live birth rates, birth weight, neonatal hypoglycemia, and other similar measures)
Change in A1C.	From first pregnancy visit to delivery	Change in A1C with CGM alone and CGM with Share™ compared to no CGM use.

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States