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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Insulin Detemir Versus Insulin NPH: A Randomized Prospective Study Comparing Glycemic Control in Pregnant Women With Diabetes

Conditions
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Diabetes, Gestational, Diabetes, Type 2

Intervention / Treatment
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* Drug: Insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levemir<br>Initial daily total insulin doses will be determined as per a weight based protocol depending on what trimester the patient is in. Sixty percent of the total daily insulin dose will be allotted to the morning total dose of insulin, while the remaining 40% will be allotted to the evening total dose. Of the morning dose, 2/3 will be allotted to the long acting insulin and 1/3 to short acting insulin. She will take half of the short-acting dose with breakfast and the other half with lunch. The evening insulin dose (40% of the total dose) will be divided in two: half the dose will be taken as short-acting insulin with dinner, and the other half as long acting insulin at bedtime. Doses are rounded down if decimals are present. | Drug: Insulin<br> <br> * Other names: Insulin Levemir;|
| Active Comparator: NPH<br>Initial daily total insulin doses will be determined as per a weight based protocol depending on what trimester the patient is in. Sixty percent of the total daily insulin dose will be allotted to the morning total dose of insulin, while the remaining 40% will be allotted to the evening total dose. Of the morning dose, 2/3 will be allotted to the long acting insulin and 1/3 to short acting insulin. She will get the entire dose of short-acting insulin with breakfast. The evening insulin dose (40% of the total dose) will be divided in two: half the dose will be taken as short-acting insulin with dinner, and the other half as long acting insulin at bedtime. Doses are rounded down if decimals are present. | Drug: Insulin<br> <br> * Other names: Insulin Levemir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 41 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Obtaining Glycemic Control | Number of each group that obtains glycemic control, defined as mean glucose <100mg/dl. | up to 41 weeks | 
| Time to Achieve Glycemic Control | Time (weeks) to achieve glycemic control, as defined as mean glucose <100mg/dl | 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 | 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. | up to 41 weeks | 
| Weight Gain | Total weight gain in pregnancy | 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 | At delivery, up to 41 weeks | 
| Gestational Age at Delivery | Gestational age at delivery | at delivery, up to 41 weeks | 
| Maternal Hypoglycemia | Number of participants with incidence of maternal hypoglycemia (<60mg/dl) | at delivery, up to 41 weeks | 
| Neonatal Bilirubin | Percentage of neonatal hyperbilirubinemia - data not collected | at birth, up to 41 weeks | 
| Intensive Care Admissions | Number of participants with incidence of neonatal intensive care unit admissions | at birth, up to 41 weeks | 
| Delivery Mode | method of delivery including cesarean section, vaginal delivery, or assisted vaginal delivery - data not collected | at birth, up to 41 weeks | 
| Birth Rate | Number of live birth rate | at birth, up to 41 weeks | 
| Shoulder Dystocia | Incidence of shoulder dystocia - data not collected | at birth, up to 41 weeks | 
| Polyhydramnios | Incidence of polyhydramnios (defined as amniotic fluid index (AFI)>20 or deepest vertical pocket ≥8) - data not collected | at each visit in pregnancy up to 41 weeks | 
| Neonatal Hypoglycemia | Number of participants with incidence of blood sugar <40mg/dl in neonate | at birth, up to 41 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin, Long-Acting