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

NCT ID: NCT05370612

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-08
• Study Completion Date: 2024-10-06

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).

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.

Conditions

Type2Diabetes; Pregnancy in Diabetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Arm 1: Continuous Glucose Monitor (CGM)

CGM for duration of pregnancy.

Group Type: EXPERIMENTAL

Dexcom G6 CGM

Intervention Type: DEVICE

Dexcom 6 CGM, an FDA approved device. Sensors will be placed on the abdomen per package instruction to collect continuous glucose data.

Experimental Group will wear CGM for the duration of their pregnancy.

Control Group will have CGM data collected for 10 days at enrollment and at 28-32 weeks into their pregnancy.

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.

Group Type: ACTIVE_COMPARATOR

Dexcom G6 CGM

Intervention Type: DEVICE

Dexcom 6 CGM, an FDA approved device. Sensors will be placed on the abdomen per package instruction to collect continuous glucose data.

Experimental Group will wear CGM for the duration of their pregnancy.

Control Group will have CGM data collected for 10 days at enrollment and at 28-32 weeks into their pregnancy.

Participant Finger Stick Glucose Monitoring

Intervention Type: OTHER

Standard of care for individual participant

Interventions

Dexcom G6 CGM

Dexcom 6 CGM, an FDA approved device. Sensors will be placed on the abdomen per package instruction to collect continuous glucose data.

Experimental Group will wear CGM for the duration of their pregnancy.

Control Group will have CGM data collected for 10 days at enrollment and at 28-32 weeks into their pregnancy.

Intervention Type: DEVICE

Participant Finger Stick Glucose Monitoring

Standard of care for individual participant

Intervention Type: OTHER

Other Intervention Names

Glucose Monitor

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacquelyn H Adams, MD

Role: PRINCIPAL_INVESTIGATOR

UW School of Medicine and Public Health

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

Protocol Version 3/18/2024

Identifier Type: OTHER

Identifier Source: secondary_id

A532860

Identifier Type: OTHER

Identifier Source: secondary_id

2022-0459

Identifier Type: OTHER

Identifier Source: secondary_id

2022-028

Identifier Type: -

Identifier Source: org_study_id