Single vs Multi-Dose Insulin for Glycemic Control (SUGAR)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorRutgers, The State University of New Jersey
About this trial
The goal of this clinical trial is to see if diabetes in pregnancy can be treated with once daily dosing of insulin instead of once daily dosing plus insulin with meals. The main question this study aims to answer is:
1. Can a once daily dose of long-acting insulin control blood sugars as well as long-acting insulin plus meal-time insulin? 2. Do babies born to mothers who take one dose of long-acting insulin have more complications after birth than babies born to mothers who take long-acting and meal-time insulin? Researchers will compare one dose of long-acting insulin per day to this plus three doses of short-acting insulin with each meal to see if blood sugars are controlled.
Participants will send their blood sugar logs to the study staff weekly, instead of to their OB/GYN, for adjustments to their insulin dosing.
Eligibility criteria
Qualifiers
Diagnosed with type 2 diabetes mellitus or A2 gestational diabetes mellitus requiring insulin use during pregnancy
Aged between 18-50
Speak English or Spanish
Disqualifiers
Pre-existing use of insulin
Gestational Age > or = 35w0d
Planning to follow-up with a doctor not associated with RWJ Barnabas or NYU Langone Health and/or deliver at a hospital other than RWJUH or NYU
Unwilling or unable to upload or email weekly blood sugar logs
Trial design
Treatments tested in this trial
- Insulin glargine alone
- Insulin glargine + insulin lispro
Treatment groups
176 Participants
are divided into 2 treatment groupsSponsors and collaborators
Rutgers, The State University of New Jersey
Lead sponsor
NYU Langone Health
Collaborator
Source ClinicalTrials.gov