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

NCT ID: NCT01875107

Last Updated: 2014-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-08-31

Brief Summary

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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

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Conditions

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Hyperglycemia in Pregnant Diabetic Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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insulin pre-treatment

insulin pre-treatment of pregnant diabetic patients who receive betamethasone

Group Type EXPERIMENTAL

insulin pre-treatment

Intervention Type DRUG

insulin pre-treatment of pregnant diabetic patients who receive betamethasone

Interventions

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insulin pre-treatment

insulin pre-treatment of pregnant diabetic patients who receive betamethasone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shelly H Tien,, M.D

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1301M26861

Identifier Type: -

Identifier Source: org_study_id

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