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

Not Applicable

Completed

• Conditions: Diabetes, Gestational; Diabetes, Type 2
• Interventions: Drug: Insulin

• Registration Number: NCT01837680
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

Brief Summary

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

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 Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-23
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Results First Submitted: 2017-01-12
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-24
• Last Update Submitted: 2017-05-24
• Results First Posted: 2017-05-30
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levemir	Insulin	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.
NPH	Insulin	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.

Primary Outcome Measures

Name	Time	Method
Glycemic Control	up to 41 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Luke's-Roosevelt Hospital Center; 🇺🇸 New York, New York, United States