Insulin Pre-treatment for Steroid-associated Hyperglycemia in Pregnant Diabetic Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01875107
First received: June 3, 2013
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Hyperglycemia in Pregnant Diabetic Patients
Drug: insulin pre-treatment
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Insulin Pre-treatment for Steroid-associated Hyperglycemia in Pregnant Diabetic Patients

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Number of hospital days until euglycemia in pregnant diabetic patients receiving steroids who are pre-treated with insulin. [ Time Frame: number of hospital days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: August 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: insulin pre-treatment
insulin pre-treatment of pregnant diabetic patients who receive betamethasone
Drug: insulin pre-treatment
insulin pre-treatment of pregnant diabetic patients who receive betamethasone

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01875107

Locations
United States, Minnesota
University of Minnesota Medical Center Not yet recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Shelly Tien, M.D.    617-894-2978    tienx015@umn.edu   
Principal Investigator: Shelly H Tien, M.D.         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Shelly H Tien, , M.D University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01875107     History of Changes
Other Study ID Numbers: 1301M26861
Study First Received: June 3, 2013
Last Updated: June 6, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014