Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy

July 7, 2020 updated by: University of Colorado, Denver

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine Care
Standard of Care in the Pregnancy and Women's Health clinic.
Active Comparator: Dexcom G4 Platinum CGM system
An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.
Device: Dexcom G4 or G5 Platinum CGM system
Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy
Active Comparator: Dexcom G4 Platinum CGM system with Share™
A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.
Device: Dexcom G4 or G5 Platinum CGM system with Share
Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in A1C.
Time Frame: From first pregnancy visit to delivery
Change in A1C with CGM alone and CGM with Share™ compared to no CGM use.
From first pregnancy visit to delivery
Evaluation of Maternal and Fetal Outcomes.
Time Frame: 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)
From first pregnancy visit to delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

DexCom, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

September 11, 2015

First Submitted That Met QC Criteria

September 18, 2015

First Posted (Estimate)

September 22, 2015

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-1006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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