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Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy

Primary Purpose

Diabetes Mellitus, Type I

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dexcom G4 or G5 Platinum CGM system
Dexcom G4 or G5 Platinum CGM system with Share
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type I

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Routine Care

Dexcom G4 Platinum CGM system

Dexcom G4 Platinum CGM system with Share™

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Changes in Glucose Variability
Glucose variability as measured by glucose excursions from CGM
Change(s) in Behavior and/or Concerns of Diabetics.
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 Outcome Measures

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

Full Information

First Posted
September 11, 2015
Last Updated
July 7, 2020
Sponsor
University of Colorado, Denver
Collaborators
DexCom, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02556554
Brief Title
Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy
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 Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
DexCom, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type I

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine Care
Arm Type
No Intervention
Arm Description
Standard of Care in the Pregnancy and Women's Health clinic.
Arm Title
Dexcom G4 Platinum CGM system
Arm Type
Active Comparator
Arm Description
An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.
Arm Title
Dexcom G4 Platinum CGM system with Share™
Arm Type
Active Comparator
Arm Description
A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.
Intervention Type
Device
Intervention Name(s)
Dexcom G4 or G5 Platinum CGM system
Intervention Description
Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy
Intervention Type
Device
Intervention Name(s)
Dexcom G4 or G5 Platinum CGM system with Share
Intervention Description
Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™
Primary Outcome Measure Information:
Title
Changes in Glucose Variability
Description
Glucose variability as measured by glucose excursions from CGM
Time Frame
From first pregnancy visit to delivery
Title
Change(s) in Behavior and/or Concerns of Diabetics.
Description
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.
Time Frame
From first pregnancy visit to delivery
Secondary Outcome Measure Information:
Title
Change in A1C.
Description
Change in A1C with CGM alone and CGM with Share™ compared to no CGM use.
Time Frame
From first pregnancy visit to delivery
Title
Evaluation of Maternal and Fetal Outcomes.
Description
Evaluation of Maternal and fetal outcomes (eclampsia/pre-eclampsia, live birth rates, birth weight, neonatal hypoglycemia, and other similar measures)
Time Frame
From first pregnancy visit to delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarit Polsky, MD, MPH
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34524020
Citation
Shah VN, Snell-Bergeon JK, Demmitt JK, Joshee P, Garcetti R, Pyle L, Polsky S. Relationship Between Time-in-Range, HbA1c, and the Glucose Management Indicator in Pregnancies Complicated by Type 1 Diabetes. Diabetes Technol Ther. 2021 Dec;23(12):783-790. doi: 10.1089/dia.2021.0093. Epub 2021 Nov 3.
Results Reference
derived
PubMed Identifier
34115946
Citation
Buschur EO, Campbell K, Pyle L, Garcetti R, Joshee P, Demmitt JK, Snell-Bergeon JK, Polsky S. Exploratory Analysis of Glycemic Control and Variability Over Gestation Among Pregnant Women with Type 1 Diabetes. Diabetes Technol Ther. 2021 Nov;23(11):768-772. doi: 10.1089/dia.2021.0138.
Results Reference
derived
PubMed Identifier
31779476
Citation
Polsky S, Garcetti R, Pyle L, Joshee P, Demmitt JK, Snell-Bergeon JK. Continuous Glucose Monitor Use With Remote Monitoring Reduces Fear of Hypoglycemia in Pregnant Women With Type 1 Diabetes: A Pilot Study. J Diabetes Sci Technol. 2020 Jan;14(1):191-192. doi: 10.1177/1932296819890864. Epub 2019 Nov 28. No abstract available.
Results Reference
derived

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Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy

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