Hyperglycemia in Pregnant Diabetic Patients Clinical Trial
Official title:
Insulin Pre-treatment for Steroid-associated Hyperglycemia in Pregnant Diabetic Patients
Our objective is to assess whether pre-treatment with a fixed dose of insulin, based on
weight, given to pregnant patients with gestational or preexisting diabetes receiving
betamethasone can provide adequate glycemic control.
Our hypothesis is that pre-treatment with a weight-based calculated insulin dose will help
maintain euglycemia for pregnant patients with gestational and preexisting diabetes after
steroid administration, and possibly impact length of hospital admission.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | August 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Pregnant women with gestational or pre-existing diabetes admitted to the University of Minnesota 2. Must be 18 years or older 3. Must speak English, Spanish, or Somali 4. Patients must receive steroids for fetal lung maturity as part of their hospital course Exclusion Criteria: 1. Pregnant women with Type 1 Diabetes, or Type 2 diabetes with evidence of end-organ disease 2. Pregnant women who need to be emergently delivered due to maternal or fetal complications of pregnancy |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Minnesota Medical Center | Minneapolis | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| University of Minnesota - Clinical and Translational Science Institute |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of hospital days until euglycemia in pregnant diabetic patients receiving steroids who are pre-treated with insulin. | Pregnant diabetic patients admitted to the hospital who receive steroids for fetal lung maturity will have their blood glucose levels checked before and after receiving steroids. Blood glucose levels will be checked fasting and postprandial until the levels are consistently less than 160. This will vary for patients, but will be on average 2 to 14 days. | number of hospital days | No |