Clinical trial NCT01837680: Glycemic Control Using Insulin Levemir Versus Insulin NPH for Diabetes in Pregnancy
Official title: Insulin Detemir Versus Insulin NPH: A Randomized Prospective Study Comparing Glycemic Control in Pregnant Women With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes, Gestational
Diabetes, Type 2
Keywords: Insulin, Long-Acting
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic Control
timeFrame: up to 41 weeks
Secondary outcomes:
measure: Number of Patients Obtaining Glycemic Control
timeFrame: up to 41 weeks
measure: Time to Achieve Glycemic Control
timeFrame: up to 41 weeks
measure: Average Fasting Glucose
timeFrame: up to 41 weeks
measure: Post-prandial Blood Glucose
timeFrame: up to 41 weeks
measure: Weight Gain
timeFrame: Number of pounds gained at each visit up to 41 weeks
measure: Neonatal Weight
timeFrame: At delivery, up to 41 weeks
measure: Gestational Age at Delivery
timeFrame: at delivery, up to 41 weeks
measure: Maternal Hypoglycemia
timeFrame: at delivery, up to 41 weeks
measure: Neonatal Bilirubin
timeFrame: at birth, up to 41 weeks
measure: Intensive Care Admissions
timeFrame: at birth, up to 41 weeks
measure: Delivery Mode
timeFrame: at birth, up to 41 weeks
measure: Birth Rate
timeFrame: at birth, up to 41 weeks
measure: Shoulder Dystocia
timeFrame: at birth, up to 41 weeks
measure: Polyhydramnios
timeFrame: at each visit in pregnancy up to 41 weeks
measure: Neonatal Hypoglycemia
timeFrame: at birth, up to 41 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's-Roosevelt Hospital Center
state: New York
Study officials:
References:
citation: Herrera KM, Rosenn BM, Foroutan J, Bimson BE, Al Ibraheemi Z, Moshier EL, Brustman LE. Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. Am J Obstet Gynecol. 2015 Sep;213(3):426.e1-7. doi: 10.1016/j.ajog.2015.06.010. Epub 2015 Jun 9.