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 groups

Locations

2
Robert Wood Johnson Univeristy Hospital08901, New BrunswickNew Jersey, United States
Maternal-Fetal Medicine at NYU Langone Obstetrics & Gynecology Associates10022, New YorkNew York, United States

Sponsors and collaborators

Rutgers, The State University of New Jersey

Lead sponsor

NYU Langone Health

Collaborator