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Completed

NCT Number: NCT02556554

Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy

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.

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Key information

Conditions

Diabetes Mellitus, Type I Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexcom G4 or G5 Platinum CGM system

Device

Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy

Dexcom G4 or G5 Platinum CGM system with Share

Device

Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™

Primary outcomes

  1. Changes in Glucose Variability

    Time frame: From first pregnancy visit to delivery

    Glucose variability as measured by glucose excursions from CGM

  2. 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.

Secondary outcomes

  1. 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.

  2. 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)

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • DexCom, Inc.

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 22, 2015
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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