RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2024-07-11
Study Completion:2029-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05662462

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. pregnant individuals age ≥18 years;
  2. 2. ≤20 weeks of gestation;
  3. 3. diagnosis of pregestational T2D and A1c ≥6.5% at the time of study enrollment;
  4. 4. Medicaid insurance;
  5. 5. English or Spanish speaking;
  6. 6. cognitively able to complete the study requirements;
  7. 7. consent to all study activities;
  8. 8. accessible for participation in study activities;
  9. 9. use a smartphone with internet access;
  10. 10. not currently using a CGM device.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Kartik Venkatesh, MD, PhD
CONTACT
614-293-2222
kartik.venkatesh@osumc.edu

Principal Investigator

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 Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-11
Study Completion Date2029-03

Study Record Updates

Study Start Date2024-07-11
Study Completion Date2029-03

Terms related to this study

Keywords Provided by Researchers

  • mHealth
  • Pregnancy
  • Type 2 diabetes
  • Continuous glucose monitoring
  • Mobile application
  • Medicaid
  • Glycemic control

Additional Relevant MeSH Terms

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