Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05662462

Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching

Led by Ohio State University · Updated on 2025-05-29

124

Participants Needed

1

Research Sites

242 weeks

Total Duration

On this page

Sponsors

O

Ohio State University

Lead Sponsor

A

Agency for Healthcare Research and Quality (AHRQ)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The ACHIEVE RCT will measure the effect of the intervention (mHealth app with CGM, provider dashboard, and care team coaching) compared to current standard care (prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist) on achieving glycemic control (hemoglobin A1c \<6.5% in the third trimester). We hypothesize a 25% absolute increase in the proportion of participants in the intervention group who will meet the target hemoglobin A1c \<6.5% in the third trimester compared to the standard care group

CONDITIONS

Official Title

Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant individuals age 18 years or older
  • Pregnancy less than 20 weeks gestation (under 20 weeks and 6 days)
  • Diagnosed with pregestational type 2 diabetes and A1c of 6.5% or higher at enrollment
  • Have Medicaid insurance
  • Speak English or Spanish
  • Able to complete study requirements cognitively
  • Consent to participate in all study activities
  • Accessible for study participation
  • Use a smartphone with internet access
  • Consent to electronic health record data use, CGM monitoring if assigned, and tracking of clinic visits and app usage
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, United States, 43210

Actively Recruiting

Loading map...

Research Team

K

Kartik Venkatesh, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here