20% cutoff group for Gestational Diabetes

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Medical College of Wisconsin, Milwaukee, WIGestational DiabetesInsulin - Drug
Eligibility
18 - 45
Female
What conditions do you have?
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Study Summary

This trial is comparing two different thresholds for when to start medical treatment for gestational diabetes mellitus (GDM). Pregnant women with GDM will be randomly assigned to start treatment when they reach at least 20% or 40% above the target goal for capillary blood glucose (CBG) levels. The investigators think that a lower threshold of 20% will lead to fewer obstetric and medical complications.

Eligible Conditions
  • Gestational Diabetes

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: The data will be collected up to 6 weeks of life

Week 6
Composite Neonatal Outcome
Week 6
Cesarean Delivery Rate
Preeclampsia

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

20% cutoff group
1 of 2
40% cutoff group
1 of 2

Active Control

416 Total Participants · 2 Treatment Groups

Primary Treatment: 20% cutoff group · No Placebo Group · Phase 4

20% cutoff group
Drug
ActiveComparator Group · 1 Intervention: Insulin · Intervention Types: Drug
40% cutoff group
Drug
ActiveComparator Group · 1 Intervention: Insulin · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: the data will be collected up to 6 weeks of life

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
572 Previous Clinical Trials
1,154,829 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,843 Previous Clinical Trials
2,152,388 Total Patients Enrolled

Eligibility Criteria

Age 18 - 45 · Female Participants · 4 Total Inclusion Criteria

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References

Frequently Asked Questions

Are there vacancies in this medical experiment for participants?

"Indeed, records on clinicaltrials.gov confirm that this research project is actively enrolling. It was initially posted on May 1st 2021 and has been modified most recently on August 12th 2022; it seeks 416 volunteers at a single trial site." - Anonymous Online Contributor

Unverified Answer

What research findings have been gained from the 40% cutoff group?

"Presently, there are 72 trials studying the effects of 40% cutoff group. Out of these studies, 13 have advanced to Phase 3. While many tests for this medication are based in Cincinnati, Ohio, an additional 248 locations across the globe offer access to clinical trials regarding this treatment." - Anonymous Online Contributor

Unverified Answer

How many individuals are involved in the current clinical investigation?

"Affirmative. Documentation hosted on clinicaltrials.gov verifies that recruitment for this medical trial is currently underway. It was initially posted May 1, 2021 and last modified August 12, 2022; 416 patients are being sought from a single site." - Anonymous Online Contributor

Unverified Answer

Is the current research open to participants of advanced age?

"This trial is offering participation to individuals between the ages of 18 and 45. For those under 18 or above 65, there are 196 studies available for minors and 938 trials suitable for seniors respectivelly." - Anonymous Online Contributor

Unverified Answer

Is the 40% cutoff a safe threshold for individuals?

"After a thorough review, the safety of 40% cutoff group was rated 3 on our organization's scale due to its Phase 4 status which indicates that it has been approved." - Anonymous Online Contributor

Unverified Answer

Do I satisfy the criteria to qualify for this research initiative?

"Participants aged between 18 and 45 with Gestational Diabetes Mellitus (GDM) are invited to join this study, for a total of 416 enrollees. Additionally, participants must be carrying viable singleton pregnancies in order to qualify." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.