Once-Daily vs Twice-Daily Insulin Glargine in Pregestational Diabetes Management
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEastern Virginia Medical School
About this trial
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. Continuous glucose monitoring will be used to track blood sugar levels. The main question the study aims to answer is: Will using insulin glargine twice a day instead of once lead to a better glucose time in range?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 menstrual period, confirmed with a first trimester ultrasound, per the recommended guidelines by the American College of Obstetricians and Gynecologists.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Use of insulin glargine once daily
DrugInsulin glargine will be used once daily
Use of insulin glargine twice daily
DrugInsulin glargine will be used twice daily
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Once-Daily Insulin GlargineActive comparator 1 intervention
Group B: Twice-Daily Insulin GlargineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Weekly Time in Range
The mean blood glucose time in range as measured by the continuous glucose monitor
Time frame
From Day 7 to Day 14 after study enrollmentSecondary outcomes
1
Hypertensive disorders of pregnancy
Development of hypertensive disorders of pregnancy
Time frame
From time of enrollment until time of delivery, up to 20 weeks following enrollment2
Preterm birth <34 weeks
Delivery at less than 34 weeks gestation
Time frame
From time of enrollment to 34 weeks gestation3
Preterm birth <37 weeks
Delivery prior to 37 weeks gestation
Time frame
From time of enrollment until 37 weeks gestation4
Spontaneous or Indicated Delivery
Whether delivery was spontaneous or there was an indication for induction or cesarean delivery
Time frame
From time of enrollment until time of delivery, up to 20 weeks following enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov