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

NCT05370612 | Completed Results DMC FDA Device

• 5 other identifiers: 2025-1028Protocol Version 3/18/2024A5328602022-04592022-028
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Type2Diabetes; Pregnancy in Diabetic

Outcome Measures

Primary Outcomes (3)

• Feasibility: Number of Participants Who Complete the Study Within 24 Month Time Period

  Completion of the study within the 24-month timeframe, including recruitment, randomization, retention, and completion of 36 out of 40 subjects will be a measure of how feasible the intervention is.

  up to 24 months

• Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences With Diabetes Management

  Individualized postpartum interviews and qualitative surveys administered at each time point will be used to gather information about participants thoughts and experiences in both arms of the trial about their ability to manage diabetes in pregnancy. Interviews will be analyzed for theme and content. Higher numbers indicate higher satisfaction with diabetes management.

  baseline, 12 weeks on study, and postpartum (up to 26 weeks on study)

• Percentage of Time Where Blood Glucose is Between 70-140 Milligrams Per Deciliter (mg/dL) - Time in Range

  The primary endpoint is the total time within range (blood glucose level 70-140 mg/dL). All CGM data will be extracted from the Dexcom server for analysis. This measure is used to determine if time in range (TIR) is a suitable clinical endpoint for a larger trial. TIR for both arms will be determined and 95% confidence intervals around the difference in means calculated. TIR will be considered suitable if the upper 95% confidence interval for the difference in means is greater than 5 units in favor of CGM.

  Baseline, 26 weeks

Secondary Outcomes (19)

• Number of Participants With Cesarean Delivery

  approximately 20 weeks on study (at time of delivery)

• Change in Hemoglobin A1c (Percentage) From Initiation to Third Trimester

  baseline (approximately 20 weeks gestation), up to 12 weeks on study (up to 32 weeks gestation)

• Percentage of Time Spent in Hyperglycemic Range

  up to 26 weeks

• Percentage of Time Spent in Hypoglycemic Range

  26 weeks

• Rates of Gestational Hypertension

  up to approximately 20 weeks on study

Study Arms (2)

Arm 1: Continuous Glucose Monitor (CGM)

EXPERIMENTAL

CGM for duration of pregnancy.

Device: Dexcom G6 CGM

Arm 2: Point of Care Glucose Testing (POCT)

ACTIVE COMPARATOR

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; Other: Participant Finger Stick Glucose Monitoring

Interventions

Dexcom G6 CGM 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 1: Continuous Glucose Monitor (CGM); Arm 2: Point of Care Glucose Testing (POCT)

Participant Finger Stick Glucose Monitoring OTHER

Standard of care for individual participant

Also known as: Glucose Monitor

Arm 2: Point of Care Glucose Testing (POCT)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DexCom, Inc.: collaborator
• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Pregnancy in Diabetics

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: UW Ob/Gyn Human Subjects Core
• Organization: UW Madison

research.crc_obgyn@wisc.edu

608-890-3345

Study Officials

• Jacquelyn H Adams, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pilot, prospective, randomized trial

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 11, 2022
• Study Start: August 8, 2022
• Primary Completion: October 6, 2024
• Study Completion: October 6, 2024
• Last Updated: March 31, 2026
• Results First Posted: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)