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NCT05662462 · ClinicalTrials.gov registry record · NA

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

A NA study of Pregnancy, High Risk and Type2diabetes, sponsored by Ohio State University.

Recruiting
Registry status
NA
Development phase
124
Enrollment target
1
Study location

NCT05662462 is a NA study of Pregnancy, High Risk and Type2diabetes that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 124 participants, below the 311-participant average among 20 other Pregnancy, High Risk trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05662462, a NA study of Pregnancy, High Risk and Type2diabetes, is actively recruiting participants, sponsored by Ohio State University.

RECRUITING
Registry status
NA
Development phase
124 participants
Enrollment target
1
Study location

Study Summary

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 Studied

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

Interventions

  • DEVICE DEXCOM G7 PRO Continuous Glucose Monitor
  • DEVICE Patient mHealth app linked to a provider dashboard
  • BEHAVIORAL Care team coaching for medical and social needs (HUB)
  • DEVICE Provider dashboard

Study Locations (1)

Ohio

  • The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine - Columbus

Trial Details

FieldValue
Enrollment Target 124 participants
Start Date 2024-07-11
Est. Completion 2029-03
Phase NA

Sponsor

Ohio State University

552 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05662462

The ClinicalTrials.gov registry entry for NCT05662462 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 311-participant average among 20 other Pregnancy, High Risk trials with a reported enrollment target (60% lower). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Pregnancy, High Risk appearing as the primary indexed condition, and to 4 interventions - of which DEXCOM G7 PRO Continuous Glucose Monitor is the first listed.

NCT05662462 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT05662462 about?

NCT05662462 is a clinical study titled "Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching". 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 (hemogl...

What is the current status of trial NCT05662462?

This trial is currently recruiting. It is a NA study. The enrollment target is 124 participants. The study started on 2024-07-11. Estimated completion is 2029-03.

What conditions does trial NCT05662462 study?

This clinical trial studies the following conditions: Pregnancy, High Risk, Type2diabetes, Pregnancy in Diabetic, Pre-Gestational Diabetes.

What interventions are being tested in trial NCT05662462?

The interventions under investigation include: DEXCOM G7 PRO Continuous Glucose Monitor (DEVICE), Patient mHealth app linked to a provider dashboard (DEVICE), Care team coaching for medical and social needs (HUB) (BEHAVIORAL), Provider dashboard (DEVICE).

Who is sponsoring clinical trial NCT05662462?

This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05662462 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.