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

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ClinicalTrials.gov Identifier: NCT01875107
Recruitment Status : Withdrawn (Time constraints of primary investigator.)
First Posted : June 11, 2013
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.


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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Insulin Pre-treatment for Steroid-associated Hyperglycemia in Pregnant Diabetic Patients
Study Start Date : August 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of hospital days until euglycemia in pregnant diabetic patients receiving steroids who are pre-treated with insulin. [ Time Frame: number of hospital days ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875107


Locations
United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55454
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

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01875107     History of Changes
Other Study ID Numbers: 1301M26861
First Posted: June 11, 2013    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs