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Continuous Glucose Monitor

Continuous Glucose Monitoring for Type 2 Diabetes in Pregnancy

N/A

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

Timeline

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

Select...

I am pregnant with one baby and less than 14 weeks along.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at delivery

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous Glucose Monitor

2021

Completed Early Phase 1

~860

0 / 1Eligibility criteria met

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

The LancetJournal

Continuous Glucose Monitoring in Pregnant Women with Type 1 Diabetes (CONCEPTT): A Multicentre International Randomised Controlled Trial

Feig, Denice S, Lois E Donovan, Rosa Corcoy, Kellie E Murphy, Stephanie A Amiel, Katharine F Hunt, Elizabeth Asztalos, et al.. 2017. “Continuous Glucose Monitoring in Pregnant Women with Type 1 Diabetes (CONCEPTT): A Multicentre International Randomised Controlled Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(17)32400-5.

BmjJournal

Effectiveness of Continuous Glucose Monitoring in Pregnant Women with Diabetes: Randomised Clinical Trial

Murphy, H. R, G. Rayman, K. Lewis, S. Kelly, B. Johal, K. Duffield, D. Fowler, P. J Campbell, and R. C Temple. 2008. “Effectiveness of Continuous Glucose Monitoring in Pregnant Women with Diabetes: Randomised Clinical Trial”. Bmj. BMJ. doi:10.1136/bmj.a1680.

Diabetes, Obesity and MetabolismJournal

Continuous Glucose Monitoring During Diabetic Pregnancy (glucomoms): A Multicentre Randomized Controlled Trial

Voormolen, Daphne N., J. Hans DeVries, Rieneke M. E. Sanson, Martijn P. Heringa, Harold W. de Valk, Marjolein Kok, Aren J. van Loon, et al.. 2018. “Continuous Glucose Monitoring During Diabetic Pregnancy (glucomoms): A Multicentre Randomized Controlled Trial”. Diabetes, Obesity and Metabolism. Wiley. doi:10.1111/dom.13310.

Diabetes CareJournal