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Technology & Coaching for Diabetes in Pregnancy

N/A

Recruiting

Led By Joshua J Joseph, MD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

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

Must have

Pregnant individuals age ≥18 years

Diagnosis of pregestational T2D and A1c ≥6.5% at the time of study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 times in the first six weeks and then monthly during study participation, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total.

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if an app and coaching can help pregnant women with diabetes better control their blood sugar. We expect a 25% increase in the proportion who reach the target.

Who is the study for?

This trial is for pregnant individuals over 18 with Type 2 Diabetes, an A1c ≥6.5%, and Medicaid insurance. They must use a smartphone, speak English or Spanish, consent to health record access and study activities including using a CGM device if assigned. Participants should be ≤20 weeks pregnant and not currently using a CGM.

What is being tested?

The trial tests whether a mobile health app linked to continuous glucose monitoring (CGM) and care team coaching can better control blood sugar levels compared to standard prenatal visits and self-monitoring. The goal is achieving hemoglobin A1c <6.5% in the third trimester of pregnancy.

What are the potential side effects?

Potential side effects may include skin irritation from the CGM device, stress or anxiety from constant glucose monitoring, privacy concerns with data sharing through the app, and possible over-reliance on technology for diabetes management.

Eligibility Criteria

Inclusion Criteria

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

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I am pregnant and 18 years old or older.

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I was diagnosed with type 2 diabetes before pregnancy and my A1c level is 6.5% or higher.

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I am mentally capable of following the study's procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total

This trial's timeline: 3 weeks for screening, Varies for treatment, and across pregnancy from randomization to delivery, which is approximately from 12 weeks to 38 weeks gestation or 26 weeks total for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The primary clinical outcome is the proportion of participants with an A1c <6.5% in the third trimester before delivery

Secondary study objectives

Blood glucose levels

Comprehension of education material

Diabetes Distress Scale (DDS)

+17 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: ACHIEVE InterventionActive Control4 Interventions

The intervention includes a multi-component, including a mobile health (mHealth) application (app), provider dashboard, DEXCOM continuous glucose monitoring (CGM), and care team coaching for medical and social needs. The intervention group will also receive standard of care as described below.

Group II: Standard of careActive Control1 Intervention

Standard of care includes prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist support.

0 / 3Eligibility criteria met