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

University of Wisconsin (UW)

Status: Active, not recruiting

Conditions: Type2Diabetes; Pregnancy in Diabetic

Treatments: Device: Dexcom G6 CGM; Other: Participant Finger Stick Glucose Monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05370612

2022-0459 (Other Identifier)

A532860 (Other Identifier)

Protocol Version 3/18/2024 (Other Identifier)

2022-028

Details and patient eligibility

About

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).

Full 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.

Enrollment: 16 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Arm 1: Continuous Glucose Monitor (CGM)

Experimental group

Description:

CGM for duration of pregnancy.

Treatment:

Device: Dexcom G6 CGM

Arm 2: Point of Care Glucose Testing (POCT)

Active Comparator group

Description:

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.

Treatment:

Other: Participant Finger Stick Glucose Monitoring

Device: Dexcom G6 CGM