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Trial record 27 of 49 for:    diabetes type 1 AND (woman OR women OR female) AND blood glucose

Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy

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ClinicalTrials.gov Identifier: NCT02556554
Recruitment Status : Active, not recruiting
First Posted : September 22, 2015
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type I Device: Dexcom G4 or G5 Platinum CGM system Device: Dexcom G4 or G5 Platinum CGM system with Share Not Applicable

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  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


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™




Primary Outcome Measures :
  1. Changes in Glucose Variability [ Time Frame: From first pregnancy visit to delivery ]
    Glucose variability as measured by glucose excursions from self-monitoring blood glucose.

  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.


Secondary Outcome Measures :
  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. Progression of diabetes complications. [ Time Frame: From first pregnancy visit to delivery ]
    Progression of diabetes complications (retinopathy, nephropathy)

  3. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556554


Locations
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
DexCom, Inc.
Investigators
Principal Investigator: Sarit Polsky, MD, MPH University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02556554     History of Changes
Other Study ID Numbers: 15-1006
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases