Overview

Definition:
-Hyperinsulinism (HI) is a condition characterized by inappropriately high insulin secretion relative to blood glucose levels, leading to recurrent, severe hypoglycemia
-It is the most common cause of persistent hypoglycemia in neonates and infants
-Genetic defects in various pancreatic beta-cell proteins involved in insulin secretion are the underlying cause.
Epidemiology:
-Congenital hyperinsulinism (CHI) affects approximately 1 in 30,000 to 50,000 live births
-The prevalence can be higher in consanguineous populations due to the predominantly autosomal recessive inheritance patterns of many CHI genes
-There is no clear gender predilection.
Clinical Significance:
-Untreated or poorly managed hyperinsulinism can lead to severe, life-threatening hypoglycemia, causing significant morbidity including neurodevelopmental impairment, seizures, coma, and death
-Early diagnosis and appropriate management are crucial for optimal outcomes and preventing long-term neurological sequelae, making its understanding vital for pediatricians and endocrinologists preparing for DNB and NEET SS examinations.

Clinical Presentation

Symptoms:
-Hypoglycemia symptoms manifest as irritability, poor feeding, lethargy, pallor, diaphoresis, tremors, and tachypnea
-In severe cases: seizures, apnea, hypotonia, and coma
-Symptoms often present within the first days or weeks of life
-A key feature is the failure of hypoglycemia to resolve with typical glucose infusions or feeds.
Signs:
-Physical examination may reveal signs of hypoglycemia like pallor and diaphoresis
-Macrosomia may be present in some genetic subtypes (e.g., GCK mutations)
-Evidence of neurological compromise such as hypotonia or seizures may be observed in advanced stages.
Diagnostic Criteria:
-Diagnosis is suspected in neonates and infants with recurrent hypoglycemia unresponsive to standard management, typically below 2.2 mmol/L (40 mg/dL) in term infants or 1.7 mmol/L (30 mg/dL) in preterm infants or neonates, accompanied by inappropriately high insulin levels and low ketone/fatty acid levels during the hypoglycemic episode
-An elevated insulin-to-glucose ratio (e.g., >0.3-0.4) is suggestive.

Diagnostic Approach

History Taking:
-Detailed birth history (birth weight, gestational age, maternal diabetes)
-History of recurrent episodes of hypoglycemia, including age of onset, frequency, duration, precipitating factors (e.g., fasting), symptoms, and response to interventions
-Family history of consanguinity or unexplained neonatal deaths or hypoglycemia is critical.
Physical Examination:
-Complete physical examination focusing on neurological status, hydration, signs of infection, and any dysmorphic features
-Assess for macrosomia or intrauterine growth restriction
-Monitor vital signs closely, especially heart rate and respiratory rate during hypoglycemic episodes.
Investigations:
-Initial investigations during a hypoglycemic episode: blood glucose, serum insulin, C-peptide, cortisol, growth hormone, free fatty acids, and ketones (beta-hydroxybutyrate)
-Persistent hyperinsulinism is confirmed by inappropriately high insulin levels (>3-5 mIU/L) and a low insulin-to-glucose ratio when glucose is <2.8 mmol/L
-Ketosis resistance is also a key indicator
-Genetic testing is essential for definitive diagnosis and to identify specific subtypes.
Differential Diagnosis: Other causes of neonatal hypoglycemia: transient HI, impaired gluconeogenesis (e.g., due to fatty acid oxidation defects, glycogen storage diseases), endocrine deficiencies (hypopituitarism, adrenal insufficiency), hyperinsulinism secondary to other conditions (e.g., sepsis, erythroblastosis fetalis), or macrosomia related hypoglycemia.

Genetic Testing

Importance:
-Genetic testing is crucial for confirming the diagnosis of congenital hyperinsulinism, identifying the specific gene mutation, predicting disease severity, guiding management, and providing genetic counseling
-It helps differentiate between diffuse and focal forms of CHI, which have implications for surgical management.
Common Genes:
-Key genes involved include KCNJ11 (Kir6.2, SUR1 subunits of KATP channel), ABCC8 (SUR1 subunit of KATP channel), GCK (glucokinase), HADH (3-hydroxyacyl-CoA dehydrogenase), UGCG (UDP-glucose ceramide glucosyltransferase), SLC16A1 (monocarboxylate transporter 1), and others
-Mutations in KCNJ11 and ABCC8 account for the majority of cases, typically presenting with diffuse disease.
Testing Methodology:
-Next-generation sequencing (NGS) panels designed for hyperinsulinism or hypoglycemia are the standard of care
-This allows for simultaneous analysis of multiple genes
-Sanger sequencing may be used for confirmation or targeted analysis of specific mutations
-Molecular karyotyping and methylation studies may be needed for specific genetic loci.
Interpretation:
-Positive genetic findings confirm the diagnosis and can predict the likelihood of responsiveness to diazoxide
-Specific mutations may correlate with focal versus diffuse disease, severity, and potential need for pancreatectomy
-Variants of unknown significance require careful interpretation in the clinical context.

Diazoxide Response

Mechanism Of Action:
-Diazoxide is a potassium channel opener
-By opening ATP-sensitive potassium (KATP) channels in pancreatic beta-cells, it hyperpolarizes the cell membrane, preventing calcium influx and thereby inhibiting insulin secretion.
Indications:
-Diazoxide is the first-line medical therapy for diazoxide-responsive forms of hyperinsulinism, particularly those caused by mutations in KCNJ11 and ABCC8 genes
-It is used to control hypoglycemia when medical management is preferred or as a bridge to surgery.
Dosing And Administration:
-Typical starting dose is 3-5 mg/kg/day, divided into 2-3 doses
-The dose is titrated upwards based on glycemic control, usually up to a maximum of 10-15 mg/kg/day
-It is usually given orally with food to minimize gastrointestinal upset and maximize absorption
-Monitoring blood glucose levels frequently is essential during titration.
Predicting Responsiveness:
-Genetic testing is the most reliable predictor
-Mutations in KCNJ11 and ABCC8 are generally associated with diazoxide responsiveness
-Patients with mutations in GCK, HADH, or other genes are typically unresponsive to diazoxide
-A trial of diazoxide can also empirically assess responsiveness if genetic results are pending or inconclusive, but this should be guided by expert opinion.
Side Effects And Monitoring:
-Common side effects include hypertrichosis (excessive hair growth), hyperglycemia, nausea, vomiting, and fluid retention
-Less common but serious side effects include neutropenia, thrombocytopenia, and cardiac abnormalities
-Regular monitoring of blood glucose, blood pressure, and complete blood count is recommended
-Hyperglycemia should be managed cautiously.

Management Principles

Initial Management:
-Immediate stabilization with intravenous glucose infusion (often requiring high rates, >10 mg/kg/min) to maintain blood glucose levels above 2.2 mmol/L
-Frequent glucose monitoring is paramount.
Medical Management:
-Diazoxide is the mainstay for responsive forms
-Other medications like octreotide or nifedipine may be used as adjuncts or in unresponsive cases, but are generally less effective and have more significant side effects
-Glucagon therapy may be used for severe, refractory hypoglycemia
-Surgical pancreatectomy (near total or subtotal) is reserved for diazoxide-unresponsive cases, particularly focal forms after localization via imaging and intraoperative assessment.
Surgical Considerations:
-Surgical pancreatectomy is indicated for diazoxide-unresponsive CHI, especially if focal disease is identified
-Focal lesions (adenomatous hyperplasia) can be surgically resected with a high chance of cure
-Diffuse disease may require near-total pancreatectomy, leading to iatrogenic diabetes mellitus and exocrine insufficiency, necessitating lifelong management.
Nutritional Support:
-Frequent feeds (every 2-3 hours) are crucial, often requiring nasogastric or gastrostomy tube feeding, especially at night, to prevent fasting-induced hypoglycemia
-A high carbohydrate diet is generally recommended.

Prognosis

Factors Affecting Prognosis:
-The prognosis depends heavily on the underlying genetic cause, severity of hypoglycemia, responsiveness to treatment, and the presence of neurological complications
-Early diagnosis and effective management are key to preventing long-term sequelae.
Outcomes:
-Patients with diazoxide-responsive HI, especially focal forms, have an excellent prognosis
-Those with diffuse disease requiring pancreatectomy have a guarded prognosis due to the risk of diabetes and exocrine insufficiency
-Neurological outcomes are significantly impacted by the duration and severity of untreated hypoglycemia.
Follow Up:
-Long-term follow-up by a pediatric endocrinologist is essential to monitor glycemic control, growth, neurodevelopment, and manage potential complications such as diabetes, exocrine insufficiency, and developmental delays
-Regular genetic and endocrine assessments are crucial.

Key Points

Exam Focus:
-Recognize hyperinsulinism as the most common cause of persistent hypoglycemia in neonates/infants
-Understand the role of insulin-C-peptide ratio in diagnosis
-Differentiate genetic subtypes based on clinical presentation and diazoxide responsiveness
-Know the mechanism and side effects of diazoxide.
Clinical Pearls:
-Always consider hyperinsulinism in a hypoglycemic infant who requires high glucose infusion rates
-Family history and consanguinity are important clues
-Genetic testing is pivotal for guiding management and predicting diazoxide response
-Remember hypertrichosis as a classic diazoxide side effect.
Common Mistakes:
-Misinterpreting insulin levels in the context of hypoglycemia
-Failing to consider HI in infants with unexplained neurological symptoms
-Initiating pancreatectomy without thorough investigation and failed medical management, especially without localizing focal disease
-Not considering diazoxide responsiveness based on genetic results.