Comparing Insulin Glargine and NPH for Diabetes in Pregnancy

This study is comparing two types of insulin, insulin glargine and insulin NPH, for managing diabetes during pregnancy. Insulin NPH has been a standard treatment, while insulin glargine is commonly used outside of pregnancy and has less research specifically for pregnant individuals. We want to see if insulin glargine is as effective as insulin NPH in preventing low blood sugar (hypoglycemia) in pregnant individuals with Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus who need insulin. You may be able to join if you are at least 18 years old, need to start insulin for diabetes in pregnancy before 34 weeks, and have established prenatal care. The study is currently recruiting 160 participants.

Study design
This is an open-label, randomized study where participants will be assigned to receive either insulin NPH or insulin glargine. It aims to see if glargine is not worse than NPH.
What's involved
You would monitor your blood sugar four times a day, log your values, and continue routine prenatal care and ultrasounds. You will also receive insulin teaching and nutrition education.
Compensation
Not stated in the trial record.
Follow-up
Your hypoglycemia will be measured from when you start insulin therapy until delivery.

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NCT06619301

RCT Glargine vs NPH for Treatment of DM in Pregnancy

Recruiting
PHASE3Ages 18+InterventionalTreatment
Loyola University
~160 participants
Updated 2024-10-01 on ClinicalTrials.gov
What's tested:Insulin glargineinsulin NPH

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hypoglycemia
Measured over From initiation of insulin therapy to delivery
Diabetes Mellitus in Pregnancy
Type 2 Diabetes Mellitus (T2DM)
Gestational Diabetes Mellitus, Class A2
1 sites across 1 states
Illinois1
  • Joana Lopes Perdigao, MD · PRINCIPAL_INVESTIGATOR · Loyola University

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Eligibility criteria

Inclusion

Patient requiring initiation of insulin therapy for Gestational Diabetes Mellitus or Type 2 Diabetes Mellitus in pregnancy
At least 18 years old
Insulin started prior to 34 weeks gestation
Established prenatal care by 14 weeks gestation

Exclusion

Those under the age of 18 years old
Those unable to consent in english
Allergy to insulin
Controlled with only diet modification or the use of oral antihyperglycemics
Has diagnosis of Type 1 Diabetes Mellitus
Receiving insulin through an insulin pump
  • HypoglycemiaFrom initiation of insulin therapy to delivery

    Episodes of hypoglycemia with blood glucose less than 60 mg/dL