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Smart patch and coach app aim to tame diabetes in pregnancy

NCT ID NCT05662462

Disease control Sponsor: Ohio State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study tests whether a continuous glucose monitor (CGM) paired with a coaching app helps pregnant women with type 2 diabetes achieve better blood sugar control compared to standard care. Participants use a Dexcom G7 CGM sensor and receive guidance through a mobile app and care team. The goal is to see if more women can reach a target A1c below 6.5% in the third trimester, potentially improving outcomes for both mother and baby.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dexcom G7 Pro Continuous Glucose Monitor and mHealth coaching app
What this could lead to
If successful, this approach could help more pregnant women with type 2 diabetes achieve safe blood sugar levels, reducing risks for both mother and baby.
What could go wrong
This is a relatively small trial (124 participants) and results may not apply to all populations. The intervention adds complexity and may not improve outcomes enough to justify the extra effort.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 124 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. pregnant individuals age ≥18 years; 2. ≤20 weeks of gestation (specifically, \<20+6 weeks); 3. diagnosis of pregestational T2D and A1c ≥6.5% at the time of study enrollment; 4. Medicaid insurance; 5. English or Spanish speaking; 6. cognitively able to complete the study requirements; 7. consent to all study activities; 8. accessible for participation in study activities; 9. use a smartphone with internet access; Participants must also consent to the study team abstracting information from their electronic health records (EHRs), using CGM for glucose monitoring if randomized to the intervention group, tracking the participants' clinic, hospital, and emergency room visits during the study period, as well as tracking the number of times the participants use the ACHIEVE mobile health (mHealth) application (app), including what activities are used in the mobile application (e.g., recording blood glucose, scheduling appointments, messaging their healthcare providers, accessing educational resources).

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Conditions

The condition(s) this trial relates to.

gestational diabetes Pregnancy in Diabetics type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pre-gestational diabetes Pregnancy in diabetic Pregnancy, high risk TYPE2DIABETES

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Columbus, Ohio, 43210, United States

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