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NCT05370612 | Recruiting | Type2Diabetes


AT GOAL: Adopting Technology for Glucose Optimization and Lifestyle in Pregnancy
Sponsor:

University of Wisconsin, Madison

Brief 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).

Condition or disease

Type 2 Diabetes

Pregnancy in Diabetic

Intervention/treatment

Dexcom G6 CGM

Participant Finger Stick Glucose Monitoring

Phase

Not Applicable

Detailed Description:

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
Criteria
Inclusion Criteria
  • Age greater than or equal to 18 years of age at enrollment
  • Ability to consent in English
  • Gestational age less than or equal to 19 weeks 6 days at enrollment
  • Appropriate dating by certain LMP or ultrasound performed less than or equal to 19 weeks 6 day
  • Diagnosis of Type 2 Diabetes less than or equal to 19 weeks 6 days
  • Singleton gestation
Exclusion Criteria
  • Age less than 18 years of age at enrollment
  • Lack of appropriate dating
  • Multiple gestations
  • Use of concentrated insulin at enrollment (ie U500)
  • Preexisting CGM in place
  • Chronic use of medications known to cause hyperglycemia, such as HIV antiretrovirals and inhaled, injectable and oral corticosteroids
  • Be unwilling or unable to present to Center for Perinatal Care for visits

AT GOAL: Adopting Technology for Glucose Optimization and Lifestyle in Pregnancy

Location Details


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AT GOAL: Adopting Technology for Glucose Optimization and Lifestyle in Pregnancy

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53715

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