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Continuous Glucose Monitoring

Continuous Glucose Monitoring vs Standard Checks for Diabetes in Pregnancy

N/A

Recruiting

Led By Jacquelyn H Adams, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than or equal to 18 years of age at enrollment

Gestational age less than or equal to 19 weeks 6 days at enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial will compare how well two different methods - continuous glucose monitoring and standard glucose checks - help pregnant patients with Type 2 Diabetes manage their condition. 40 participants will be monitored for 26 weeks.

Who is the study for?

The AT GOAL trial is for pregnant individuals over 18 with Type 2 Diabetes, not beyond their 19th week of pregnancy. They must understand English and have a single baby pregnancy. Those using concentrated insulin, preexisting CGM devices, or medications causing high blood sugar can't join.Check my eligibility

What is being tested?

This study compares two methods of monitoring blood sugar in pregnant patients with Type 2 Diabetes: traditional finger stick checks versus the Dexcom G6 continuous glucose monitor (CGM). Participants will be observed for about six months to see which method they prefer and how well each controls glucose levels.See study design

What are the potential side effects?

Potential side effects may include skin irritation from CGM sensor adhesives or discomfort from frequent finger sticks. Continuous monitoring might also cause anxiety due to constant awareness of glucose levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am less than 20 weeks pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Feasibility: Number of Participants Who Complete the Study within 24 month time period

Percentage of Time Where Blood Glucose is between 70-140 milligrams per deciliter (mg/dL)

Secondary outcome measures

Change in hemoglobin A1c (percentage) from initiation to third trimester

Incidence of neonatal hypoglycemia

Number of Participants with Cesarean Delivery

+13 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1: Continuous Glucose Monitor (CGM)Experimental Treatment1 Intervention

CGM for duration of pregnancy.

Group II: Arm 2: Point of Care Glucose Testing (POCT)Active Control2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexcom G6 CGM

2019

N/A

~320

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

DexCom, Inc.Industry Sponsor

137 Previous Clinical Trials

29,812 Total Patients Enrolled

University of Wisconsin, MadisonLead Sponsor

1,187 Previous Clinical Trials

3,169,457 Total Patients Enrolled

Jacquelyn H Adams, MDPrincipal InvestigatorUW School of Medicine and Public Health

Media Library

Dexcom G6 CGM (Continuous Glucose Monitoring) Clinical Trial Eligibility Overview. Trial Name: NCT05370612 — N/A

Type 2 Diabetes Research Study Groups: Arm 2: Point of Care Glucose Testing (POCT), Arm 1: Continuous Glucose Monitor (CGM)

Type 2 Diabetes Clinical Trial 2023: Dexcom G6 CGM Highlights & Side Effects. Trial Name: NCT05370612 — N/A

Dexcom G6 CGM (Continuous Glucose Monitoring) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05370612 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially qualify for participation in this clinical research?

"To participate in this trial, individuals must be of childbearing age (18-45) and have a diagnosis of diabetes during their pregnancy. Up to 40 patients will be accepted into the program."

Answered by AI

Is this medical trial currently accepting participants?

"Clinicaltrials.gov informs us that this clinical trial is currently open to new patients, and was initially posted on August 8th 2022 with its last update made in October 28th of the same year."

Answered by AI

Is there an age restriction for participants of this experiment?

"Patients between 18 and 45 years of age are eligible for this clinical trial. There is a separate study open to participants below the legal age of consent, as well as an additional 686 trials specifically designed for those over 65."

Answered by AI

What is the current enrollment count of this research?

"Affirmative. According to clinicaltrials.gov, this research project is presently open for patient enrollment after first being posted on August 8th 2022 and most recently updated October 28th 2022. In total, 40 patients are expected to be admitted from 1 medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "AT GOAL: Adopting Technology for Glucose Optimization and Lifestyle in Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05370612.

All > Pregnancy