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

Diabetes, Gestational Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837680
• Other study ID #: 12-166
• Status: Completed
• Phase: N/A
• First received: April 4, 2013
• Last updated: May 24, 2017
• Start date: March 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2017
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Diabetes, Type 2

Intervention

Drug:
• Insulin

Locations

Country	Name	City	State
United States	St. Luke's-Roosevelt Hospital Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Patients Obtaining Glycemic Control	Number of each group that obtains glycemic control, defined as mean glucose <100mg/dl.	up to 41 weeks
Secondary	Time to Achieve Glycemic Control	Time (weeks) to achieve glycemic control, as defined as mean glucose <100mg/dl	up to 41 weeks
Secondary	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
Secondary	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
Secondary	Weight Gain	Total weight gain in pregnancy	Number of pounds gained at each visit up to 41 weeks
Secondary	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
Secondary	Gestational Age at Delivery	Gestational age at delivery	at delivery, up to 41 weeks
Secondary	Maternal Hypoglycemia	Number of participants with incidence of maternal hypoglycemia (<60mg/dl)	at delivery, up to 41 weeks
Secondary	Neonatal Bilirubin	Percentage of neonatal hyperbilirubinemia - data not collected	at birth, up to 41 weeks
Secondary	Intensive Care Admissions	Number of participants with incidence of neonatal intensive care unit admissions	at birth, up to 41 weeks
Secondary	Delivery Mode	method of delivery including cesarean section, vaginal delivery, or assisted vaginal delivery - data not collected	at birth, up to 41 weeks
Secondary	Birth Rate	Number of live birth rate	at birth, up to 41 weeks
Secondary	Shoulder Dystocia	Incidence of shoulder dystocia - data not collected	at birth, up to 41 weeks
Secondary	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
Secondary	Neonatal Hypoglycemia	Number of participants with incidence of blood sugar <40mg/dl in neonate	at birth, up to 41 weeks