Individualized Treatment for Gestational Diabetes

Magee Womens Hospital of UPMC, Pittsburgh, PA
Gestational Diabetes+2 More ConditionsGlyburide - Drug
18 - 45

Study Summary

This trial will investigate whether an individualized treatment approach for gestational diabetes, based on each woman's specific mechanism for the condition, is more effective than the current standard approach.

Eligible Conditions
  • Gestational Diabetes

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Delivery

Week 2
Therapeutic procedure
Cord blood c-peptide
Cord blood glucose
Maternal glucose control
Proportion of participants who deliver by primary cesarean
Proportion of participants who developed hypertensive diseases in pregnancy
Week 16
Proportion of participants who report suitability of the study procedures
Proportion of women who are eligible, screened, enroll and remain in the study
Proportion of women who remain on same treatment during study
Hour 72
Neonatal lean body mass

Trial Safety

Phase-Based Safety

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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2 Treatment Groups

Individualized Treatment
1 of 2
Usual Care
1 of 2

Active Control

60 Total Participants · 2 Treatment Groups

Primary Treatment: Individualized Treatment · No Placebo Group · Phase 4

Individualized TreatmentActiveComparator Group · 3 Interventions: Glyburide, Insulin, Metformin · Intervention Types: Drug, Drug, Drug
Usual CareActiveComparator Group · 3 Interventions: Glyburide, Insulin, Metformin · Intervention Types: Drug, Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: delivery

Who is running the clinical trial?

Maisa N. Feghali, MDLead Sponsor
2 Previous Clinical Trials
73 Total Patients Enrolled
Maisa N Feghali, MDPrincipal InvestigatorUniversity of Pittsburgh
2 Previous Clinical Trials
60 Total Patients Enrolled

Eligibility Criteria

Age 18 - 45 · Female Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

Is recruitment for this study still open?

"Affirmative, the clinical trial is actively recruiting according to details hosted on This particular investigation was initially posted in February 28th 2018 and its information has been updated most recently on April 4th 2022. A total of 60 patients have to be recruited from a single medical centre for this study." - Anonymous Online Contributor

Unverified Answer

What research has been conducted to identify the efficacy of personalized therapies?

"Currently, 242 research projects are underway for Individualized Treatment with 57 trials in their final phase. Tustin, California is the primary location of these studies; however, there are 2346 medical centres performing clinical trials related to this treatment method." - Anonymous Online Contributor

Unverified Answer

Has the FDA sanctioned Individualized Treatment?

"Our team assigned Individualized Treatment a score of 3, indicating that the treatment has already gone through multiple rounds of trials and is officially approved." - Anonymous Online Contributor

Unverified Answer

Does this trial accept those in the senior demographic?

"This medical research is recruiting individuals aged between 18 and 45 years old." - Anonymous Online Contributor

Unverified Answer

Who is eligible to join this medical experiment?

"This medical experiment seeks 60 participants suffering from diabetes, who are pregnant and between 18-45 years of age. Crucially, candidates ought to be beyond 24 weeks gestation with plans for a 3 hour oral glucose tolerance test." - Anonymous Online Contributor

Unverified Answer

Are there any limits on the number of participants accepted in this empirical research?

"Affirmative. Data hosted on conclusively declares that this medical investigation, which was initially published on February 28th 2018, is currently recruiting patients. Sixty people need to be enlisted from 1 site in total." - Anonymous Online Contributor

Unverified Answer

What conditions typically benefit from a personalized form of care?

"Individualized Treatment is a popular option for [type 2 diabetes]( mellitus patients, but can also be leveraged to help manage glycemic control, exercise-induced issues and gestational diabetes mellitus (GDM)." - 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.