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

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01875107
Enrollment
0
Registered
2013-06-11
Start date
2013-08-31
Completion date
2014-08-31
Last updated
2014-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia in Pregnant Diabetic Patients

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.

Interventions

DRUGinsulin pre-treatment

insulin pre-treatment of pregnant diabetic patients who receive betamethasone

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of hospital days until euglycemia in pregnant diabetic patients receiving steroids who are pre-treated with insulin.number of hospital daysPregnant 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026