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.

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

Diabetes, Gestational

Diabetes, Type 2

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).

Insulin

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

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.

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

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

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

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.

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 participants with incidence of maternal hypoglycemia (<60mg/dl)

Percentage of neonatal hyperbilirubinemia - data not collected

Number of participants with incidence of neonatal intensive care unit admissions

method of delivery including cesarean section, vaginal delivery, or assisted vaginal
delivery - data not collected

Incidence of shoulder dystocia - data not collected

Incidence of polyhydramnios (defined as amniotic fluid index (AFI)>20 or deepest vertical
pocket ≥8) - data not collected

Number of participants with incidence of blood sugar <40mg/dl in neonate

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.

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.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status