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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 Type 2 Diabetes and Pregnancy, High Risk, sponsored by Ohio State University.
- Recruiting
- Registry status
- NA
- Development phase
- 124
- Enrollment target
- 1
- Study location
NCT05662462: Recruiting NA study of Type 2 Diabetes and Pregnancy, High Risk, sponsored by Ohio State University.
NCT05662462 is a NA study of Type 2 Diabetes and Pregnancy, High Risk that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 124 participants, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05662462, a NA study of Type 2 Diabetes and Pregnancy, High Risk, 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
Primary Outcome
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 outcome
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2024-07-11 |
| Est. Completion | 2029-03 |
| Phase | NA |
What NCT05662462 shows while recruiting
NCT05662462 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (97% lower).
The record links to 4 conditions, with Type 2 Diabetes appearing as the primary indexed condition, and to 4 interventions - of which DEXCOM G7 PRO Continuous Glucose Monitor is the first listed.
NCT05662462 reports a single indexed study location in 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: Type 2 Diabetes, Pregnancy, High Risk, 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.
Learn More About Clinical Trials
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Where NCT05662462's enrollment target sits among peer trials
124 132nd of 327 higher than 196 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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