Insulin Pre-treatment for Steroid-associated Hyperglycemi... | NCT01875107

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

NCT01875107

Sponsor

University of Minnesota

Status

Withdrawn

Last Update Posted

Sep 12, 2014Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Hyperglycemia in Pregnant Diabetic Patients

Interventions

insulin pre-treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Time constraints of primary investigator.

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Aug 2014Estimated

Completion Date

Aug 2014Estimated

First Submitted Date

Jun 3, 2013

First Submission Date that Met QC Criteria

Jun 6, 2013

First Posted Date

Jun 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2014

Last Update Posted Date

Sep 12, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
insulin pre-treatment	Experimental	insulin pre-treatment of pregnant diabetic patients who receive betamethasone	Drug: insulin pre-treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin pre-treatment	Drug	insulin pre-treatment of pregnant diabetic patients who receive betamethasone	insulin pre-treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shelly H Tien,, M.D	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota Medical Center		Minneapolis	Minnesota	55454	United States