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

Phase 4

Withdrawn

• Conditions: Hyperglycemia in Pregnant Diabetic Patients
• Interventions: Drug: insulin pre-treatment

• Registration Number: NCT01875107
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-11
• Study Start: 2013-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-10
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
insulin pre-treatment	insulin pre-treatment	insulin pre-treatment of pregnant diabetic patients who receive betamethasone

Primary Outcome Measures

Name	Time	Method
Number of hospital days until euglycemia in pregnant diabetic patients receiving steroids who are pre-treated with insulin.	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.

Trial Locations

Locations (1)

University of Minnesota Medical Center; 🇺🇸 Minneapolis, Minnesota, United States