Insulin Management Strategies for Diabetes during Pregnancy

Phase 2

Recruiting

Led By Ashley N Battarbee, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Maternal age 18-50

Gestational or pregestational type 2 diabetes mellitus treated with daily insulin injection(s) or oral hypoglycemic agents such as metformin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up delivery

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the best way to manage diabetes during pregnancy after a woman has been given a steroid to help her baby's development.

Who is the study for?

This trial is for pregnant women aged 18-50 with gestational or pregestational type 2 diabetes, treated with insulin injections or medications like metformin. They must be hospitalized for corticosteroid administration due to the risk of premature birth between weeks 23 and almost 37 of pregnancy.

What is being tested?

The study tests three strategies to control blood sugar after receiving corticosteroids: adding sliding scale insulin, increasing usual home insulin doses, and giving continuous insulin infusions. It also uses a Dexcom G6 monitor to track glucose levels.

What are the potential side effects?

Potential side effects include variations in blood sugar levels that may require close monitoring and adjustments in treatment. Continuous infusion might lead to discomfort at the infusion site and increased healthcare interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 18 and 50.

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I have type 2 diabetes during or before pregnancy and am on insulin or metformin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during study intervention assessed for maximum of 5 days after acs

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during study intervention assessed for maximum of 5 days after acs

This trial's timeline: 3 weeks for screening, Varies for treatment, and during study intervention assessed for maximum of 5 days after acs for reporting.