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

NCT01875107 | Withdrawn Phase 4

• 1 other identifier: 1301M26861
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia in Pregnant Diabetic Patients

Outcome Measures

Primary Outcomes (1)

• 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.

  number of hospital days

Study Arms (1)

insulin pre-treatment

EXPERIMENTAL

insulin pre-treatment of pregnant diabetic patients who receive betamethasone

Drug: insulin pre-treatment

Interventions

insulin pre-treatment DRUG

insulin pre-treatment of pregnant diabetic patients who receive betamethasone

insulin pre-treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55454, United States

Location

Study Officials

• Shelly H Tien,, M.D

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: June 11, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 12, 2014

Record last verified: 2014-09

Locations

US (1)