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Dietitian support may cut insulin need in pregnancy diabetes

NCT ID NCT06127823

Disease control Sponsor: Steno Diabetes Center Copenhagen 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 08, 2026 · Updated 4 times

Summary

This study tests whether intensive dietary counseling from a dietitian can help women with gestational diabetes control blood sugar without needing insulin. 214 women will be randomly assigned to either intensive nutrition support or standard care. The main goal is to see if more women can manage with diet alone.

What this could mean

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

Active substance
Dietary counselling
What this could lead to
If it works, this could show that intensive dietary support reduces the need for insulin in gestational diabetes, improving maternal and child outcomes.
What could go wrong
This is a single-center trial with 214 participants, so results may not apply broadly. The intervention is behavioral, and outcomes depend on adherence.

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

214 people

The number who actually took part.

Started

Jan 2024

Finished

Jun 2026

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Newly diagnosed women with GDM referred to Department of Obstetrics Herlev Hospital * Women diagnosed with GDM based on 2-hour OGTT plasma glucose value ≥ 9.0 mmol/l * Women diagnosed with GDM based on at least 2 plasma glucose measurements above targets (either pre-prandial ≥6.0 mmol/l, or 2-hours postprandial ≥8.0 mmol/l) * GA at GDM diagnosis ≤ 34 * Women with an estimated probability of ≥20% for initiating insulin treatment during pregnancy. The estimated probability is based on a logistic regression model developed at SDCC and includes the following variables: prepregnancy BMI, GA at GDM diagnosis, and HbA1c at GDM diagnosis. In cases where HbA1c has not been measured during the initial visit with the dietitian (screening visit), prepregnancy BMI, GA at the time of diagnosis and 2H OGTT will be used to estimate the probability of initiating insulin therapy. * Provided voluntary written informed parental consent in Danish or English or after translation by an interpreter for non-Danish and non-English speaking parents Exclusion Criteria: * Bariatric surgery * Other intercurrent illness (e.g., cancer, ulcerative colitis) as judged by medical experts * Uncontrolled medical issues, as judged by medical experts * Concomitant participation in other clinical trials that could interfere with the INTENSE- GDM Trial as evaluated by the principle investigator * Unable to understand the informed consent/procedures regardless of spoked language

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Conditions

The condition(s) this trial relates to.

diabetes mellitus gestational diabetes Nutritional and Metabolic Diseases

As listed by the trial registrant

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

GDM Gestational diabetes Medical nutrition therapy Nutrition therapy Nutritional and metabolic diseases

Contacts and locations

Locations

  • Steno Diabetes Center Copenhagen

    Herlev, DK-2730, Denmark

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