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 in Pregnancy Associated With Type 1 Diabetes
1 other identifier
interventional
67
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 11, 2015
CompletedFirst Posted
Study publicly available on registry
September 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedResults Posted
Study results publicly available
July 21, 2020
CompletedJuly 21, 2020
July 1, 2020
2 years
September 11, 2015
May 13, 2019
July 7, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Changes in Glucose Variability
Glucose variability as measured by glucose excursions from CGM
From first pregnancy visit to delivery
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.
From first pregnancy visit to delivery
Secondary Outcomes (2)
Change in A1C.
From first pregnancy visit to delivery
Evaluation of Maternal and Fetal Outcomes.
From first pregnancy visit to delivery
Study Arms (3)
Routine Care
NO INTERVENTIONStandard of Care in the Pregnancy and Women's Health clinic.
Dexcom G4 Platinum CGM system
ACTIVE COMPARATORAn intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.
Dexcom G4 Platinum CGM system with Share™
ACTIVE COMPARATORA treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.
Interventions
Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy
Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- DexCom, Inc.collaborator
Study Sites (1)
University of Colorado
Aurora, Colorado, 80045, United States
Related Publications (3)
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.
PMID: 34524020DERIVEDBuschur 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.
PMID: 34115946DERIVEDPolsky 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.
PMID: 31779476DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sarit Polsky, MD, MPH
- Organization
- Regents of the University of Colorado
Study Officials
- PRINCIPAL INVESTIGATOR
Sarit Polsky, MD, MPH
University of Colorado, Denver
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2015
First Posted
September 22, 2015
Study Start
August 1, 2015
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
July 21, 2020
Results First Posted
July 21, 2020
Record last verified: 2020-07