Neonatal diabetes mellitus

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2Active trials63Specialists8Treatment centers

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UniteRare data is sourced from FDA.gov, ClinicalTrials.gov, Orphanet, OMIM, and NORD.
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Overview

Neonatal diabetes mellitus (NDM) is a rare form of diabetes that appears in the first six months of life. Unlike the more common type 1 diabetes, which is caused by the immune system attacking insulin-producing cells, neonatal diabetes is almost always caused by a genetic change that affects how the pancreas makes or releases insulin. Insulin is a hormone the body needs to move sugar from the blood into cells for energy. Without enough insulin, blood sugar levels rise dangerously high. Babies with NDM may be born smaller than expected, feed poorly, lose weight, and become very ill quickly. High blood sugar can cause excessive urination, dehydration, and in severe cases, a life-threatening condition called diabetic ketoacidosis (DKA). Some children also have other health problems depending on which gene is affected, such as muscle weakness, developmental delays, or problems with the thyroid or pancreas. There are two main types: transient NDM, where diabetes goes away on its own within months but may return later in life, and permanent NDM, where insulin treatment is needed lifelong. Treatment depends on the genetic cause. Many children with mutations in the KCNJ11 or ABCC8 genes can switch from insulin injections to oral sulfonylurea pills, which is a major improvement in quality of life. Early genetic testing is essential to guide the best treatment.

Also known as:

Key symptoms:

Very high blood sugar levelsExcessive thirstFrequent urination or very wet diapersPoor feeding or refusing to eatSlow weight gain or weight lossDehydrationExtreme tiredness or low energyIrritability or unusual fussinessSmall size at birth (intrauterine growth restriction)VomitingRapid breathing (sign of diabetic ketoacidosis)Developmental delays (in some genetic forms)Muscle weakness (in some genetic forms)Seizures (in some genetic forms, such as DEND syndrome)

Inheritance

Variable

Can be inherited in different ways depending on the underlying gene

Age of Onset

Neonatal

Begins at or shortly after birth (first 4 weeks)

Orphanet ↗NORD ↗

FDA & Trial Timeline

10 events
Mar 2026to Investigate Impact of Diet and Physical Activity Based Nurse Led Interventions on Maternal Outcomes and Neonatal Outcomes in Women With Gestational Diabetes Mellitus (GDM)

University of Health Sciences Lahore — NA

TrialNOT YET RECRUITING
Mar 2026COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus

Institute of Mother and Child, Warsaw, Poland — NA

TrialNOT YET RECRUITING
Jan 2026Prenatal Exercise Including Perineal Massage and Maternal-Neonatal Outcomes

South China Normal University — NA

TrialNOT YET RECRUITING
Dec 2025Characterisation of a Population of Adults Suffering From Cystic Fibrosis in a Belgian Reference Center

Erasme University Hospital

TrialENROLLING BY INVITATION
Dec 2025Automated Insulin for Management of Intrapartum Glycemia

University of California, San Francisco — NA

TrialRECRUITING
Dec 2025Pasteurised Donor Human Milk Supplementation for Term Babies

The University of Queensland — PHASE4

TrialRECRUITING
Sep 2025Accuracy of Interstitial Continuous Glucose Sensors in Neonates

Women and Infants Hospital of Rhode Island

TrialNOT YET RECRUITING
Aug 2025Early Detection of Gestational Diabetes Mellitus in Pregnancy

University of Massachusetts, Worcester — NA

TrialRECRUITING
Aug 2025Scalable Public Health Empowerment, Research, and Education Sites (SPHERES)

Oxford University Clinical Research Unit Indonesia — NA

TrialNOT YET RECRUITING
Jun 2025Gestational Diabetes and Health Outcomes in Mothers and Babies

Medical University of Graz

TrialRECRUITING

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

No FDA-approved treatments are currently listed for Neonatal diabetes mellitus.

2 clinical trialsare actively recruiting — trials can provide access to cutting-edge therapies.

View clinical trials →

Clinical Trials

2 recruitingView all trials with filters →
Other2 trials
Ultrasound Findings in Diabetic Pregnancies
Actively Recruiting
· Sites: Norfolk, Virginia · Age: 1845 yrs
Characterisation of a Population of Adults Suffering From Cystic Fibrosis in a Belgian Reference Center
Enrolling by Invitation
PI: Laurent Crenier (Erasme University Hospital) · Sites: Brussels · Age: 1899 yrs

Specialists

Showing 25 of 63View all specialists →
MM
Michio Hirano, MD
NEW YORK, NY
Specialist
PI on 10 active trials
WP
William T Cade, PT, PhD
HARKER HEIGHTS, TX
Specialist
PI on 5 active trials
LM
Lisa S Duus, MD
Specialist
PI on 1 active trial1 Neonatal diabetes mellitus publication
TM
Tacjana Pressler, MD
Specialist
PI on 1 active trial
TM
Tor Biering-Sørensen, Professor MD PhD MPH
Hellerup, Copenhagen
Specialist

Rare Disease Specialist

PI on 1 active trial
DP
Daniel Faurholt-Jepsen, MD PhD
Specialist
PI on 1 active trial
MM
Maria Dons, MD
Specialist
PI on 1 active trial
FM
Fumihiko Urano, MD
SAINT LOUIS, MO
Specialist
PI on 1 active trial
TD
Terese L Katzenstein, MD PhD DMSc
Specialist
PI on 1 active trial
DM
Dominique Grenet, MD
Specialist
PI on 2 active trials
RP
Rebekka F Thudium, MD PhD
Specialist
PI on 1 active trial
SD
Susanne D Poulsen, MD DMSc
Specialist
PI on 1 active trial
AM
Andrea Kelly, MD, MSCE
Specialist
PI on 3 active trials
XM
Xavier Ayrignac, MD
Specialist
PI on 1 active trial
MP
Michel Polak, MD, PhD
Specialist
PI on 3 active trials
NZ
Noam Zilberman
Specialist
PI on 2 active trials
RR
Rémi Rabasa-Lhoret
Specialist
PI on 7 active trials3 Neonatal diabetes mellitus publications
VM
Victor Gordeuk, MD
CHICAGO, IL
Specialist
PI on 1 active trial
LP
Laurence KESSLER, MD, PhD
Specialist
PI on 1 active trial
MP
May Faraj, PDt, PhD
Specialist
PI on 1 active trial
LM
Liangkun Ma
Specialist
PI on 1 active trial296 Neonatal diabetes mellitus publications
PP
Pierre Yves BENHAMOU, MD, phD
Specialist
PI on 1 active trial
CM
Charles THIVOLET, MD
Specialist
PI on 1 active trial

Treatment Centers

8 centers
🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🏥 NORD

UCLA Rare Disease Day Program

UCLA Health

📍 Los Angeles, CA

Travel Grants

No travel grants are currently matched to Neonatal diabetes mellitus.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Neonatal diabetes mellitus

Disease timeline:

New recruiting trial: PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)

A new clinical trial is recruiting patients for Neonatal diabetes mellitus

New recruiting trial: Beta-cell Response to Incretin Hormones in Cystic Fibrosis

A new clinical trial is recruiting patients for Neonatal diabetes mellitus

New recruiting trial: EXtremely Early-onset Type 1 Diabetes EXtremely Early-onset Type 1 Diabetes (A Musketeers' Memorandum Study)

A new clinical trial is recruiting patients for Neonatal diabetes mellitus

New recruiting trial: New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.

A new clinical trial is recruiting patients for Neonatal diabetes mellitus

New recruiting trial: Continuous Glucose Monitoring and OGTT Screen for Cystic Fibrosis Related Diabetes in Cystic Fibrosis

A new clinical trial is recruiting patients for Neonatal diabetes mellitus

New recruiting trial: Identification of Dysglycemia With Continuous Glucose Monitoring to Assess Clinical Evolution in Cystic Fibrosis

A new clinical trial is recruiting patients for Neonatal diabetes mellitus

New recruiting trial: Gestational Diabetes and Health Outcomes in Mothers and Babies

A new clinical trial is recruiting patients for Neonatal diabetes mellitus

New recruiting trial: Intrapartum Glucose Control and Risk of Neonatal Hypoglycemia

A new clinical trial is recruiting patients for Neonatal diabetes mellitus

New recruiting trial: Danish Diabetes Birth Registry 2

A new clinical trial is recruiting patients for Neonatal diabetes mellitus

New recruiting trial: Pasteurised Donor Human Milk Supplementation for Term Babies

A new clinical trial is recruiting patients for Neonatal diabetes mellitus

Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

Rare disease caregiving can be isolating. Connect with counseling and peer support.

Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Questions for your doctor

Bring these to your next appointment

  • Q1.Which gene is causing my child's diabetes, and how does that affect the best treatment choice?,Is my child a candidate to switch from insulin to oral sulfonylurea pills, and what would that process look like?,Will my child's diabetes go away on its own, or will they need treatment for life?,Are there other health problems we should watch for based on the specific genetic cause?,What should I do if my child's blood sugar is dangerously low or high at home?,Should other family members be tested for the same genetic change?,What support resources are available for our family, including psychological support and patient groups?

Common questions about Neonatal diabetes mellitus

What is Neonatal diabetes mellitus?

Neonatal diabetes mellitus (NDM) is a rare form of diabetes that appears in the first six months of life. Unlike the more common type 1 diabetes, which is caused by the immune system attacking insulin-producing cells, neonatal diabetes is almost always caused by a genetic change that affects how the pancreas makes or releases insulin. Insulin is a hormone the body needs to move sugar from the blood into cells for energy. Without enough insulin, blood sugar levels rise dangerously high. Babies with NDM may be born smaller than expected, feed poorly, lose weight, and become very ill quickly. Hi

At what age does Neonatal diabetes mellitus typically begin?

Typical onset of Neonatal diabetes mellitus is neonatal. Age of onset can vary across affected individuals.

Are there clinical trials for Neonatal diabetes mellitus?

Yes — 2 recruiting clinical trials are currently listed for Neonatal diabetes mellitus on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Neonatal diabetes mellitus?

25 specialists and care centers treating Neonatal diabetes mellitus are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.