No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 50
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
176 (estimated)
Sponsor
Rutgers, The State University of New Jersey · Other
Who this trial is looking for
This trial is looking for pregnant women with diabetes who need insulin. Participants will take one daily dose of long-acting insulin and keep track of their blood sugar levels each week.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with gestational diabetes or type 2 diabetes.
I am between 18 and 50 years old.
I speak English or Spanish.
You may not be able to join if
I am currently using insulin.
I am 35 weeks or further along in my pregnancy.
I plan to see a doctor not associated with RWJ Barnabas or NYU Langone Health.
I am unwilling or unable to send weekly blood sugar logs.
I cannot use Lispro or Lantus insulin.
I have a fetal anomaly.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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-ac…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Diagnosed with type 2 diabetes mellitus or A2 gestational diabetes mellitus requiring insulin use during pregnancy
* Aged between 18-50
* Speak English or Spanish
Exclusion Criteria:
* Pre-existing use of insulin
* Gestational Age \> or = 35w0d
* Planning to follow-up with a…
Inclusion Criteria:
* Diagnosed with type 2 diabetes mellitus or A2 gestational diabetes mellitus requiring insulin use during pregnancy
* Aged between 18-50
* Speak English or Spanish
Exclusion Criteria:
* 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
* Contraindication to Lispro or Lantus insulin, or patient chooses to not utilize insulin therapy
* Fetal anomaly present
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