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Technology & Coaching for Diabetes in Pregnancy

Q: Are there opportunities for enrollment in this research endeavor?

<p>Contrary to expectations, clinicaltrials.gov pointed out that this trial is no longer enrolling participants. The initial post was made on January 1st 2023 and the last update took place on December 14th 2022. Luckily there are still 1476 other trials recruiting patients at present time.</p>

N/A

Waitlist Available

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Blood glucose levels

Comprehension of education material

Diabetes Distress Scale (DDS)

+19 more

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

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

829 Previous Clinical Trials

505,619 Total Patients Enrolled

5 Trials studying Diabetes

272 Patients Enrolled for Diabetes

Agency for Healthcare Research and Quality (AHRQ)FED

399 Previous Clinical Trials

6,822,224 Total Patients Enrolled

15 Trials studying Diabetes

26,249 Patients Enrolled for Diabetes

DexCom, Inc.Industry Sponsor

137 Previous Clinical Trials

29,728 Total Patients Enrolled

15 Trials studying Diabetes

3,728 Patients Enrolled for Diabetes

Media Library

ACHIEVE Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05662462 — N/A

Diabetes Research Study Groups: ACHIEVE Intervention, Standard of care

Diabetes Clinical Trial 2023: ACHIEVE Intervention Highlights & Side Effects. Trial Name: NCT05662462 — N/A

ACHIEVE Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05662462 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for enrollment in this research endeavor?

"Contrary to expectations, clinicaltrials.gov pointed out that this trial is no longer enrolling participants. The initial post was made on January 1st 2023 and the last update took place on December 14th 2022. Luckily there are still 1476 other trials recruiting patients at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Kartik K Venkatesh 2024. "Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05662462.