Back to resultsInsulin Pre-treatment for Steroid-associated Hyperglycemia in Pregnant Diabetic Patients
Primary Purpose
Hyperglycemia in Pregnant Diabetic Patients
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
insulin pre-treatment
Sponsored by
About this trial
This is an interventional treatment trial for Hyperglycemia in Pregnant Diabetic Patients
Eligibility Criteria
Inclusion Criteria:
- Pregnant women with gestational or pre-existing diabetes admitted to the University of Minnesota
- Must be 18 years or older
- Must speak English, Spanish, or Somali
- Patients must receive steroids for fetal lung maturity as part of their hospital course
Exclusion Criteria:
- Pregnant women with Type 1 Diabetes, or Type 2 diabetes with evidence of end-organ disease
- Pregnant women who need to be emergently delivered due to maternal or fetal complications of pregnancy
Sites / Locations
- University of Minnesota Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
insulin pre-treatment
Arm Description
insulin pre-treatment of pregnant diabetic patients who receive betamethasone
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01875107
First Posted
June 3, 2013
Last Updated
September 10, 2014
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01875107
Brief Title
Insulin Pre-treatment for Steroid-associated Hyperglycemia in Pregnant Diabetic Patients
Official Title
Insulin Pre-treatment for Steroid-associated Hyperglycemia in Pregnant Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Time constraints of primary investigator.
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia in Pregnant Diabetic Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
insulin pre-treatment
Arm Type
Experimental
Arm Description
insulin pre-treatment of pregnant diabetic patients who receive betamethasone
Intervention Type
Drug
Intervention Name(s)
insulin pre-treatment
Intervention Description
insulin pre-treatment of pregnant diabetic patients who receive betamethasone
Primary Outcome Measure Information:
Title
Number of hospital days until euglycemia in pregnant diabetic patients receiving steroids who are pre-treated with insulin.
Description
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.
Time Frame
number of hospital days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women with gestational or pre-existing diabetes admitted to the University of Minnesota
Must be 18 years or older
Must speak English, Spanish, or Somali
Patients must receive steroids for fetal lung maturity as part of their hospital course
Exclusion Criteria:
Pregnant women with Type 1 Diabetes, or Type 2 diabetes with evidence of end-organ disease
Pregnant women who need to be emergently delivered due to maternal or fetal complications of pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelly H Tien,, M.D
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Insulin Pre-treatment for Steroid-associated Hyperglycemia in Pregnant Diabetic Patients
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