Glycemic Control Using Insulin Levemir Versus Insulin NPH for Diabetes in Pregnancy
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/8/2015 |
| Start Date: | March 2013 |
| End Date: | December 2014 |
| Contact: | Kimberly M Herrera, MD |
| Email: | kherrera@chpnet.org |
| Phone: | 212-523-6266 |
Insulin Detemir Versus Insulin NPH: A Randomized Prospective Study Comparing Glycemic Control in Pregnant Women With Diabetes
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.
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.
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).
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).
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
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St Luke's - Roosevelt Hospital Center With 523 beds, Mount Sinai St. Luke's serves as...
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