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Compares treatment options for Pregestational Diabetes
Official title Once-Daily vs Twice-Daily Insulin Glargine in Pregestational Diabetes Management
ClinicalTrials.gov ID: NCT07224893
What this study is testing
What is Use of insulin glargine once daily?
Use of insulin glargine once daily is an investigational medicine, given as an once-daily, being studied as a potential treatment for pregestational diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine if taking insulin glargine twice a day instead of once a day will better manage pregestational diabetes in pregnant patients. Participants in this study will be randomly assigned to one of two groups: a group that takes insulin glargine once a day, and a group that takes it twice.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients older than 18 years of age;
- The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study;
- Type II diabetes mellitus requiring insulin;
- The patient is between 24 weeks 0 days and 28 weeks 0 days of gestation at the time of enrollment. Gestational age will be determined by last...
- Currently using or willing to use a clinically indicated continuous glucose monitor for glycemic management
You likely can't join if
- Known allergy or reaction to insulin glargine, or concurrent medical condition where the use of insulin glargine is contraindicated;
- Contraindication to CGM use, patient declines CGM use, or CGM not covered by patient's insurance;
- Known or suspected fetal anomaly or aneuploidy;
- Prisoners;
- Ongoing prenatal care outside EVMS or planned delivery outside Sentara Norfolk General Hospital.
The study team makes the final eligibility decision.
Where it's taking place
- Norfolk, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Norfolk, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.