About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Insulin glargine
DrugInsulin Glargine is regularly used outside of pregnancy and its efficacy is well documented. It is a current medication we regularly use in pregnancy, however, there is limited data for comparison to the standard, NPH.
insulin NPH
DrugInsulin NPH is a current medication used in pregnancy for diabetes mellitus. It has been used as the standard form of insulin.
Treatment groups
Trial outcomes
Primary outcomes
Hypoglycemia
Episodes of hypoglycemia with blood glucose less than 60 mg/dL
Secondary outcomes
Large for Gestational Age
Birth weight greater than or equal to the 90th percentile for gestational age
Shoulder dystocia
Diagnosed by delivering providing
Sponsors and contacts
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