ACHIEVE Study: Technology and Coaching for Type 2 Diabetes in Pregnancy
This study, called ACHIEVE, is testing a new approach to help pregnant individuals with Type 2 diabetes manage their blood sugar. It uses a mobile health (mHealth) app, a continuous glucose monitor (DEXCOM G7 PRO CGM) to track blood sugar levels, a dashboard for healthcare providers, and coaching for medical and social needs. This new approach is being compared to standard care, which includes prenatal visits and self-monitoring of blood sugar. The goal is to see if the new approach helps more participants achieve a specific blood sugar target (A1c less than 6.5%) in their third trimester before delivery. You may be able to join if you are pregnant, at or before 20 weeks of gestation, have pregestational Type 2 diabetes with an A1c of 6.5% or higher, and have Medicaid insurance. The study plans to enroll 124 participants.
- Study design
- This is an interventional study comparing a new technology and coaching approach to standard care. It plans to enroll 124 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured from up to 20 weeks of gestation until delivery, an average of 5 months.
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Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- 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
Who to contact
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What this trial measures
- The primary clinical outcome is the proportion of participants with an A1c <6.5% in the third trimester before deliveryFrom ≤20 weeks of gestation to delivery, an average of 5 months
A1c is a blood test that represents the average glucose over the previous three months. Our outcome threshold is slightly higher than the target of \<6.0 recently recommended by ADA because: 1) our target population of pregnant individuals includes those with poor glycemic control at enrollment, 2) an aggressive target \<6% can result in frequent episodes of hypoglycemia, of particular concern for participants in the standard care arm without CGM, and 3) the frequency of adverse neonatal outcomes are similar with third trimester A1c 6-6.4% vs. \<6%. A1c will be assessed once per trimester, consistent with ADA and ACOG guidelines for T2D management in pregnancy, and at delivery. For participants with \>1 value in the third trimester, the value closest to delivery will be used. A standard assay will be used for HbA1c. We will evaluate HbA1c as an absolute percentage of total hemoglobin using reference standards per the Diabetes Control and Complications Trial Reference Method.