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Sugar pill or savior? supplement may cut insulin use in pregnancy diabetes

NCT ID NCT03875755

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether myo-inositol, an oral dietary supplement, can help pregnant women with gestational diabetes control their blood sugar without needing insulin shots. About 1,080 women with newly diagnosed gestational diabetes will receive either myo-inositol or a placebo alongside standard diet and lifestyle advice. The goal is to see if the supplement reduces the number of women who require insulin therapy.

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 1,080 people

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

Started

Mar 2020

Expected to finish

Jan 2027

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 to 45 years

Sex

Anyone

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: * Age ≥18 years * Singleton pregnancy * GDM diagnosed during pregnancy according to IADPSG (International Association of the Diabetes and Pregnancy Study Groups) criteria, i.e. * fasting plasma glucose between 92 mg/dL (5.1 mmol/L) and 125 mg/dL (6.9 mmol/L) * and/or 1-hour plasma glucose value after 75 g oral glucose tolerance test (OGTT) ≥ 180 mg/dL (10.0 mmol/L) * and/or 2-hour plasma glucose value between 153 mg/dL (8.5 mmol/L) and 199 mg/dL ((11.0 mmol/L) * or overt diabetes according to 2-hours post OGTT plasma glucose value ≥ 200 mg/dl * 6 to 37 (+6 days) amenorrhea weeks at the time of randomization * Capacity for self-monitoring of blood glucose * Signed informed consent Exclusion Criteria: * Insulin use before randomization during this pregnancy * Use of other oral hypoglycemic agents during this pregnancy * Long time corticosteroid treatment * Pre-existing diabetes before pregnancy * Overt diabetes diagnosed during pregnancy according to fasting plasma glucose ≥ 126 mg/dL (7 mmol/l) * Lack of Social Insurance * Insufficient French understanding and speaking * Participant in another investigational drug study at inclusion visit * Fetal malformation diagnosed by previous fetal ultrasound * Personal history of any bariatric surgery * Hypersensitivity to any ingredient of dietary supplement formulation

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Conditions

The condition(s) this trial relates to.

diabetes mellitus gestational diabetes

As listed by the trial registrant

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

Gestational diabetes mellitus

Contacts and locations

Locations

  • Hopital Avicenne

    Bobigny, France

  • Hôpital Avicenne

    Bobigny, 93000, France

More trials for these conditions

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