Health TrialsbyHealthPanel

Single vs Multi-Dose Insulin for Glycemic Control (SUGAR)

ConditionsDiabetes in PregnancyGestational Diabetes
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Insulin glargine alone

    Drug

    Once daily dosing of insulin glargine

  • Insulin glargine + insulin lispro

    Drug

    Once daily dosing of insulin glargine + three times daily dosing of insulin lispro with meals

Treatment groups

176 Participants
are divided into 2 treatment groups
Group A: Insulin glargine aloneExperimental treatment 1 intervention
Group B: Insulin glargine + Insulin lisproActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite outcome

NICU admission, neonatal hyperglycemia, neonatal hypoglycemia, large for gestational age, shoulder dystocia, hyperbilirubinemia stillbirth, and neonatal death

Time frame
From enrollment to delivery

Secondary outcomes

1

Compliance with medication

How often participant is taking the prescribed insulin regimen

Time frame
From enrollment to delivery
2

% of patients in experimental group who are able to remain on insulin glargine only

Percentage of patients who remain on insulin glargine only throughout their pregnancy instead of switching to standard of care due to uncontrolled blood sugars

Time frame
From enrollment to delivery
3

Maternal complication rates

Maternal complications include cesarean section, hypertensive disorders of pregnancy, use of insulin during labor, pre-eclampsia, number of days spent in hospital

Time frame
From enrollment to maternal discharge from delivery hospitalization
4

Birth complications

Pre-term delivery, shoulder dystocia, stillbirth rate. All will be reported as yes/no

Time frame
Delivery to discharge of infant from birth hospitalization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rutgers, The State University of New Jersey

Lead sponsor

NYU Langone Health

Collaborator

Source ClinicalTrials.gov
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