Dexcom G6 CGM for Pregnancy in Diabetics

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Wisconsin, Madison, WI
Pregnancy in Diabetics+2 More
Dexcom G6 CGM - Device
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

This study will assess differences in patient preferences and glucose control between continuous glucose monitoring and standard glucose checks in pregnant patients with Type 2 Diabetes. 40 participants will be on study for approximately 182 days (26 weeks).

Eligible Conditions

  • Pregnancy in Diabetics
  • Type2Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 16 Secondary · Reporting Duration: up to 24 months

Week 26
Qualitative Outcome: Interviews to understand Participant Sense of Control around Glucose Monitoring
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
Week 20
Number of Participants with Cesarean Delivery
Week 32
Satisfaction and Quality of Life Survey Scores (5-point likert scale)
Satisfaction and Quality of Life Survey Scores (7-point likert scale)
Satisfaction and Quality of Life Survey Scores (Participant Counts)
Week 32
Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences with Diabetes Management
Week 32
Change in hemoglobin A1c (percentage) from initiation to third trimester
up to 24 months
Feasibility: Number of Participants Who Complete the Study within 24 month time period
up to 26 weeks
Incidence of neonatal hypoglycemia
Percentage of Time Where Blood Glucose is between 70-140 milligrams per deciliter (mg/dL)
Percentage of time spent in hyperglycemic range
Percentage of time spent in hypoglycemic range
Rates of NICU Admission
Rates of fetal macrosomia
Week 37
Rates of spontaneous preterm delivery
Week 20
Rates of gestational hypertension
Rates of polyhydramnios
Rates of preeclampsia

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Arm 2: Point of Care Glucose Testing (POCT)
1 of 2
Arm 1: Continuous Glucose Monitor (CGM)
1 of 2
Active Control
Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Dexcom G6 CGM · No Placebo Group · N/A

Arm 1: Continuous Glucose Monitor (CGM)
Device
Experimental Group · 1 Intervention: Dexcom G6 CGM · Intervention Types: Device
Arm 2: Point of Care Glucose Testing (POCT)ActiveComparator Group · 2 Interventions: Dexcom G6 CGM, Participant Finger Stick Glucose Monitoring · Intervention Types: Device, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexcom G6 CGM
2019
N/A
~60

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
Closest Location: University of Wisconsin · Madison, WI
Photo of wi university of wisconsin 1Photo of madison 2Photo of madison 3
2003First Recorded Clinical Trial
1 TrialsResearching Pregnancy in Diabetics
383 CompletedClinical Trials

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,052 Previous Clinical Trials
2,559,871 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
121 Previous Clinical Trials
13,075 Total Patients Enrolled
3 Trials studying Pregnancy in Diabetics
734 Patients Enrolled for Pregnancy in Diabetics
Jacquelyn H Adams, MDPrincipal InvestigatorUW School of Medicine and Public Health

Eligibility Criteria

Age 18 - 65 · Female Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be younger than or equal to 18 years of age at enrollment.
Appropriate dating by certain LMP or ultrasound performed less than or equal to 19 weeks 6 day.
The diagnosis of Type 2 Diabetes was made less than or equal to 19 weeks 6 days.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.