University of Wisconsin, Madison
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).
Type 2 Diabetes
Pregnancy in Diabetic
Dexcom G6 CGM
Participant Finger Stick Glucose Monitoring
Not Applicable
This pilot single site randomized control trial will compare the blood glucose control and participant satisfaction scores of continuous glucose monitoring vs standard glucose checks in pregnant women with a prior diagnosis of Type 2 diabetes. The study population will consist of 40 women who are less than 20 weeks pregnant at time of enrollment who have a pre-pregnancy diagnosis of Type 2 diabetes. Participants will be randomized to one of two treatment arms. Arm 1: Placement of Dexcom G6 continuous glucose monitor for glucose monitoring for duration of pregnancy Arm 2: Continuation of standard glucose finger sticks with placement of a blinded Dexcom Pro G6 continuous glucose sensor for two ten day periods (at enrollment and again at 28-32 weeks gestation) Participant accrual will occur over 18 months at 1 site. Participants will complete 3 study visits, all of which will be in conjunction with previously scheduled prenatal or diabetes visits: at the time of consent (less than 20 weeks gestation), 28-32 weeks gestation, and 2-6 weeks postpartum.. Surveys will be administered at each time point. At the final visit, patients will be asked for participate in a 2-5 minute directed interview as well. Primary Objective To examine the feasibility of completing a study to assess for differences in patient preferences and glucose control between continuous glucose monitoring and standard glucose checks in pregnant patients with Type 2 Diabetes. Secondary Objectives To estimate the effect of continuous glucose monitoring devices placed prior to 20 weeks in pregnancy in patients with Type 2 diabetes on time in range, as measured between 28-32 weeks of pregnancy. To assess patient satisfaction to continuous glucose monitoring during pregnancy To estimate the effect of continuous glucose monitoring on the incidence of neonatal morbidity and mortality.}}
Study Type : | Interventional |
Estimated Enrollment : | 40 participants |
Masking : | None (Open Label) |
Masking Description : | Participant will know what arm they are randomized to, participants and physicians in Arm 2 will be blinded to CGM data collected for 10 days at 2 timepoints. |
Primary Purpose : | Diagnostic |
Official Title : | Continuous Glucose Monitoring in Pregnant Patients With Type 2 Diabetes, a Mixed Methods Approach |
Actual Study Start Date : | August 8, 2022 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm 1: Continuous Glucose Monitor (CGM) CGM for duration of pregnancy. |
Device: Dexcom G6 CGM |
Active Comparator: Arm 2: Point of Care Glucose Testing (POCT) Point of care finger sticks for glucose monitoring. At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data. |
Device: Dexcom G6 CGM |
Ages Eligible for Study: | 18 Years to 45 Years |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
University of Wisconsin
Madison, Wisconsin, United States, 53715