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RecruitingPhase 3

RCT Glargine vs NPH for Treatment of DM in Pregnancy

Randomized Controlled Trial of Glargine Versus Neutral Protamine Hagedorn Insulin for the Treatment of Diabetes Mellitus in Pregnancy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients are instructed to continue monitoring blood glucose 4 times a day (fasting and 2 hours after each meal), log their blood glucose values in MyLoyola chart, continue routine prenatal care with maternal fetal medicine/high risk obstetric clinic, and continue routine ultrasound with serial growth ultrasounds and antenatal fetal surveillance."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy. Currently, many hospitals differ among use of insulin for management of DM in pregnancy, with NPH, glargine and detemir being the most commonly used forms of basal insulin. Outside of pregnancy, NPH is rarely used with glargine and determir being the more common forms of insulin used due to their fewer episodes of hypoglycemia in these patients. Detemir has been well studied in pregnancy and found to be noninferior to NPH. Unfortunately, glargine has not been as well studied in pregnancy. Thus, with this study we want to compare glargine and NPH. The purpose of this study is to compare two different forms of insulin (Glargine and NPH) that we regularly use to manage diabetes mellitus in pregnancy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Study sites (1)

IL