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Continuous Glucose Monitor

Continuous Glucose Monitoring for Type 2 Diabetes in Pregnancy

Waitlist Available
Led By Gianna L Wilkie, MD
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Singleton gestation less than or equal to 14 weeks at initial obstetric visit
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up at delivery
Awards & highlights

Study Summary

This trial will compare the effects of a continuous glucose monitor vs standard care on pregnant women with type 2 diabetes mellitus and their infants.

Who is the study for?
This trial is for pregnant women over 18 with type 2 diabetes, less than 14 weeks into their pregnancy, and receiving care at UMASS Memorial Health Care. They must have a confirmed diagnosis of T2DM and be able to consent. Women with multiple pregnancies or planning care outside UMMHC, or those with type 1 or gestational diabetes cannot join.Check my eligibility
What is being tested?
The study compares the use of a continuous glucose monitor (CGM) versus routine fingerstick blood glucose monitoring in managing type 2 diabetes during pregnancy. It aims to see how each method affects baby's size at birth, mother's sugar control, satisfaction with treatment, and other pregnancy outcomes.See study design
What are the potential side effects?
While CGMs are generally safe, potential side effects include skin irritation from the sensor adhesive, inaccurate readings leading to mismanagement of glucose levels which could affect both mother and baby's health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am pregnant with one baby and less than 14 weeks along.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and at delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Large for Gestational Age Infant
Secondary outcome measures
APGAR less than 7 at 5 minutes of life
Gestational age at delivery
Hypertensive Disorders of Pregnancy
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Continuous Glucose Monitoring (CGM)Experimental Treatment1 Intervention
Patients will be randomized to application of a continuous glucose monitor (CGM). They will apply the device in the clinical setting and be instructed how to download their information onto their smartphones or using the CGM device reader. They will use the CGM for the duration of the pregnancy until delivery.
Group II: Fingerstick Glucose MonitoringActive Control1 Intervention
Patients will be randomized to checking their blood glucose with fingerstick monitors at time of fasting in the AM, and 2 hours after each meal. This is the standard of care for patients in the pregnancy diabetes clinic.
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Glucose Monitor
Completed Early Phase 1

Find a Location

Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor
342 Previous Clinical Trials
976,430 Total Patients Enrolled
Gianna L Wilkie, MDPrincipal InvestigatorUniversity of Massachusetts, Worcester
2 Previous Clinical Trials
310 Total Patients Enrolled

Media Library

Continuous Glucose Monitor (Continuous Glucose Monitor) Clinical Trial Eligibility Overview. Trial Name: NCT05317585 — N/A
Type 2 Diabetes Research Study Groups: Continuous Glucose Monitoring (CGM), Fingerstick Glucose Monitoring
Type 2 Diabetes Clinical Trial 2023: Continuous Glucose Monitor Highlights & Side Effects. Trial Name: NCT05317585 — N/A
Continuous Glucose Monitor (Continuous Glucose Monitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05317585 — N/A

Frequently Asked Questions

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

Are there any vacancies for participation in this research project?

"According to the records on clinicaltrials.gov, this investigation is no longer actively recruiting participants; an initial posting date of July 1st 2023 and a last update from April 6th 2022 confirm that it has ended its search for enrollees. Nevertheless, there are 815 other trials searching patient volunteers simultaneously."

Answered by AI
Recent research and studies
~120 spots leftby Jul 2026