Glycemic Control Using Insulin Levemir Versus Insulin NPH for Diabetes in Pregnancy

St. Luke's-Roosevelt Hospital Center105 enrolled

Overview

The aim of this study is to compare glycemic control in pregnant women treated with insulin Detemir and pregnant women treated with NPH insulin. These women are diagnosed with gestational diabetes (GDM) in the current pregnancy or have a preexisting diagnosis of type 2 diabetes (T2DM) at the onset of pregnancy. Our hypothesis is that there is no difference between these two treatment modalities in terms of glycemic control in diabetes.

The experimental method will be a randomized controlled trial performed at Roosevelt Hospital in our Diabetes in Pregnancy Program (DIPP). Perinatologists managing the patient in DIPP determine when patients need further treatment with medical therapy. Patients undergoing care at DIPP may require medical intervention in the following clinical scenarios: failure of diet alone to control glycemic indices and grossly abnormal glucose tolerance screening test results suggesting disease of such severity that diet alone would not be sufficient. After verbally counseling the patient, she will be recruited for the study by the investigators. An extensive explanation of the objectives of the study will be presented to the patient, as well as written copies of the protocol and consent. After informed consent is given, patients will be randomized to management with either insulin NPH or detemir together with rapid acting insulin aspart (Novolog) with meals, as necessary. The primary outcome will be level of glycemic control defined as overall mean blood glucose in pregnancy. This is a well established measure of overall glycemic control that has been used in numerous publications in the obstetric literature on diabetes in pregnancy. Participants will be followed until they deliver, with an expected range of 6-16 weeks depending on when the patient was enrolled in the study. The mean glucose will be determined by the sum of average glucose at each visit divided by the number of visits).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

105

Conditions

Diabetes, Gestational Diabetes, Type 2

Interventions

InsulinDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * All pregnant women with a viable singleton or multiple gestation at ≤34 weeks with gestational diabetes diagnosed in their current pregnancy requiring medical therapy. "Early diagnosis" GDM patients will also be included; which is defined as a diagnosis made prior to 24 weeks. * Women with known preexisting type 2 diabetes that are in need of medical therapy. Exclusion criteria: * Patients \<18 years of age * a diagnosis of GDM outside of the gestational age stated above * known allergy/prior adverse reaction to insulin NPH or insulin detemir. * type 1 diabetes

Locations (1)

St. Luke's-Roosevelt Hospital Center

New York, New York, United States

Outcomes

Primary Outcomes

Glycemic Control

Overall mean glucose value of pregnancy. This will be determined by the sum of average glucose value at each visit, divided by the number of visits.

Time frame: up to 41 weeks

Secondary Outcomes

Number of Patients Obtaining Glycemic Control

Number of each group that obtains glycemic control, defined as mean glucose \<100mg/dl.

Time frame: up to 41 weeks

Time to Achieve Glycemic Control

Time (weeks) to achieve glycemic control, as defined as mean glucose \<100mg/dl

Time frame: up to 41 weeks

Average Fasting Glucose

Mean fasting blood glucose in pregnancy, as determined by the sum of the mean fasting glucose at each visit divided by the number of visits

Time frame: up to 41 weeks

Post-prandial Blood Glucose

Mean post-prandial blood glucose in pregnancy, as defined as the sum of the average post-prandial blood glucose at each visit divided by the number of visits.

Time frame: up to 41 weeks

Weight Gain

Total weight gain in pregnancy

Time frame: Number of pounds gained at each visit up to 41 weeks

Neonatal Weight

Neonatal weight was estimated for occurrence of neonatal macrosomia (≥4000g birth weight) and neonatal LGA(large for gestational age)(birth weight \>90th percentile for gestational age

Time frame: At delivery, up to 41 weeks

Data from ClinicalTrials.gov

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