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

Description

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

Pre-Gestational Diabetes, Type2diabetes, Pregnancy in Diabetic, Pregnancy, High Risk

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Pre-Gestational Diabetes
Intervention / Treatment

-

Contacts and Locations

Columbus

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. pregnant individuals age ≥18 years;
  • 2. ≤20 weeks of gestation;
  • 3. diagnosis of pregestational T2D and A1c ≥6.5% at the time of study enrollment;
  • 4. Medicaid insurance;
  • 5. English or Spanish speaking;
  • 6. cognitively able to complete the study requirements;
  • 7. consent to all study activities;
  • 8. accessible for participation in study activities;
  • 9. use a smartphone with internet access;
  • 10. not currently using a CGM device.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ohio State University,

Naleef Fareed, PhD, MBA, PRINCIPAL_INVESTIGATOR, Ohio State University

Joshua J Joseph, MD, PRINCIPAL_INVESTIGATOR, Ohio State University

Kartik K Venkatesh, MD, PhD, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

2029-03