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Glycemic Targets for Gestational Diabetes

N/A

Recruiting

Research Sponsored by Richard H. Lee

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from birth until discharge (up to 1 year)

Awards & highlights

Study Summary

This trial will compare two different ways of managing diabetes during pregnancy to see if one results in better outcomes.

Eligible Conditions

Gestational Diabetes
Type 2 Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from birth until discharge (up to 1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from birth until discharge (up to 1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from birth until discharge (up to 1 year) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Difference in birth weight

Secondary outcome measures

3rd or 4th degree laceration

A1c 36 weeks

A1c enrollment

+52 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Interventional ArmExperimental Treatment1 Intervention

Patients in the experimental arm will be instructed to check blood sugars seven times per day: fasting, pre-prandial, and 1 hour after each meal. The glycemic targets for the intervention arm will be defined as follows: fasting ≤80 mg/dL, pre-prandial ≤80 mg/dL, and 1-hour postprandial ≤110 mg/dL. Patients who do not achieve glycemic goals with diet and exercise will be started on medical therapy (metformin or insulin) at the discretion of a maternal-fetal medicine subspecialist and endocrinologist.

Group II: Control ArmActive Control1 Intervention

Patients in the control arm will be instructed to check blood sugars seven times per day: fasting, pre-prandial, and 1 hour after each meal. The glycemic targets for the control arm will be defined as follows: fasting ≤95 mg/dL, pre-prandial ≤95 mg/dL, and 1-hour postprandial ≤140 mg/dL (i.e. conventional targets). Patients who do not achieve glycemic goals with diet and exercise will be started on medical therapy (metformin or insulin) at the discretion of a maternal-fetal medicine subspecialist and endocrinologist.

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Find a Location

Who is running the clinical trial?

Richard H. LeeLead Sponsor

University of Southern CaliforniaLead Sponsor

905 Previous Clinical Trials

1,596,198 Total Patients Enrolled

Frequently Asked Questions

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

Are additional volunteers sought for this clinical trial?

"Affirmative, clinicaltrials.gov indicates that the recruitment process for this research study is ongoing and has been since July 8th 2021. The 120 participants needed are being recruited from a single site and the trial was last edited on October 18th 2022."

Answered by AI

How many participants are enrolled in this research study?

"Affirmative. Clinicaltrials.gov displays that this clinical trial is presently recruiting participants. Initially posted on July 8th 2021 and updated recently on October 18th 2022, the research team are searching for 120 individuals at a single site."

Answered by AI