Congenital Hyperinsulinemia (CHI)

Congenital hyperinsulinemia (CHI) is a rare condition where a baby or child’s pancreas makes too much insulin from birth or early life. Insulin lowers blood sugar, so these children have repeated low blood sugar (hypoglycemia), which can damage the brain if it is not treated quickly and well. National Organization for Rare Disorders+1

Congenital hyperinsulinemia (CHI) is a rare genetic disease in which the pancreas makes too much insulin from birth. Insulin is the hormone that lowers blood sugar. In CHI, insulin is released even when blood sugar is already low. This causes repeated or long-lasting episodes of hypoglycemia (low blood sugar), which can damage the brain if not treated quickly and correctly.PMC+2Semantic Scholar+2

In many children with CHI, changes (mutations) in genes such as ABCC8 and KCNJ11 affect the potassium channels of the beta cells in the pancreas. These channels help the cell sense blood sugar and decide when to release insulin. When they do not work, the cells “think” sugar is high all the time and keep releasing insulin. CHI can be diffuse (whole pancreas affected) or focal (a small area affected), and the type affects the choice of treatment, including surgery.jcrpe.org+1

Because the brain depends on a steady supply of glucose, fast diagnosis and good long-term management of congenital hyperinsulinism are essential. International guidelines stress rapid correction of low blood sugar with intravenous dextrose, close monitoring, and then long-term medical, nutritional, and sometimes surgical strategies to prevent further damage.PMC+2Karger Publishers+2

In a healthy person, insulin is released mainly after eating, when blood sugar is high. In congenital hyperinsulinemia, insulin release does not “switch off” when blood sugar is low. The pancreas keeps pushing sugar into the body’s cells, so sugar in the blood falls to dangerous levels again and again. SpringerLink+1

CHI can be mild or very severe. It may be short-term (transient) in some babies or last for life (persistent) in others. The disease is usually caused by changes (mutations) in genes that control how the insulin-making beta cells in the pancreas sense and respond to glucose. Frontiers+1

Other names

Congenital hyperinsulinemia is known by several other names in the medical literature. These names all describe the same basic problem: too much insulin and low blood sugar in early life. Wikipedia+1

Common other names include:

1. Familial hyperinsulinism

2. Hyperinsulinemic hypoglycemia of infancy

3. Persistent hyperinsulinemic hypoglycemia of infancy (PHHI)

4. Congenital hyperinsulinism of infancy

5. Neonatal hyperinsulinism

6. Genetic hyperinsulinism

7. Nonsyndromic genetic hyperinsulinism (when it occurs alone) NCBI+1

Types of congenital hyperinsulinemia

Doctors group congenital hyperinsulinemia in several ways. One way is by how much of the pancreas is affected. Focal CHI means only a small patch of beta cells in the pancreas is abnormal. Diffuse CHI means almost all beta cells are abnormal. Atypical CHI shows a mixed or irregular pattern. SpringerLink+1

Another way is by how long the disease lasts. Transient CHI happens in the newborn period and improves over days or months. Persistent CHI continues long-term and often needs ongoing medical or surgical treatment to keep blood sugar safe. Frontiers+1

Types can also be described by cause. Many children have KATP-channel CHI, due to mutations in the ABCC8 or KCNJ11 genes that form the potassium-ATP (KATP) channel in beta cells. Others have GLUD1 (GDH)-related CHI, GCK (glucokinase)-related CHI, HADH (SCHAD)-related CHI, or forms linked to HNF4A and HNF1A genes. NCBI+1

Some children have syndromic CHI, where hyperinsulinism occurs as part of a wider syndrome such as Beckwith–Wiedemann or others with overgrowth or congenital anomalies. Others have nonsyndromic CHI, where the problem is limited to insulin regulation and blood sugar without major malformations in other organs. Frontiers+1

Causes of congenital hyperinsulinemia

1. ABCC8 gene mutations
   Mutations in the ABCC8 gene, which codes for the SUR1 part of the KATP channel in beta cells, are the most common cause of congenital hyperinsulinism. These changes keep the channel closed, cause constant cell depolarization, and trigger insulin release even when blood sugar is low. Brieflands+1

2. KCNJ11 gene mutations
   The KCNJ11 gene encodes the Kir6.2 subunit of the same KATP channel. Mutations here also prevent the channel from opening properly. This makes beta cells “think” glucose is always high, which drives excess insulin secretion and recurrent hypoglycemia. SpringerLink+1

3. GLUD1 (glutamate dehydrogenase) mutations
   Changes in the GLUD1 gene cause glutamate dehydrogenase hyperinsulinism. The enzyme becomes overactive, increases ATP production in beta cells, and stimulates insulin release. These patients often have both hypoglycemia and high blood ammonia levels. SpringerLink+1

4. GCK (glucokinase) activating mutations
   Glucokinase acts as a “glucose sensor” in beta cells. Activating mutations make it sense glucose as higher than it really is. As a result, insulin is released at much lower blood sugar levels and the child develops fasting and post-meal hypoglycemia. SpringerLink+1

5. HADH (SCHAD) deficiency
   Mutations in HADH (also called SCHAD) impair fatty acid oxidation in beta cells. This alters metabolic signaling and leads to abnormal insulin release, especially after protein-rich meals, causing protein-sensitive hypoglycemia in some children. SpringerLink+1

6. HNF4A gene mutations
   Heterozygous mutations in HNF4A can cause a diazoxide-responsive form of diffuse CHI. These babies may be large for gestational age at birth and have transient or persistent hypoglycemia, later sometimes developing maturity-onset diabetes of the young (MODY). Orpha.net+1

7. HNF1A gene mutations
   HNF1A mutations can also lead to congenital hyperinsulinism that may improve over time and then evolve into diabetes in adolescence or adulthood. This reflects a shift from early beta-cell over-activity to later beta-cell failure. SpringerLink+1

8. UCP2 gene variants
   Rare variants in the UCP2 gene, which codes for an uncoupling protein in mitochondria, have been reported in some HI patients. These changes may raise ATP levels in beta cells and stimulate insulin, although this mechanism is less common than KATP defects. SpringerLink+1

9. SLC16A1 promoter mutations
   Gain-of-function changes in SLC16A1 (MCT1 transporter) allow lactate and pyruvate to enter beta cells when they normally would not. This can cause exercise-induced hyperinsulinism, where insulin surges occur during or after strenuous activity. SpringerLink+1

10. HK1 and other glycolytic gene mutations
    Mutations in HK1 and a few other metabolic genes have been linked to CHI. They change how glucose is processed, leading to inappropriate ATP production and insulin secretion at low blood glucose levels. SpringerLink+1

11. Beckwith–Wiedemann syndrome
    This overgrowth syndrome, caused by imprinting defects on chromosome 11p15, may include pancreatic islet cell hyperplasia and severe neonatal hyperinsulinism. Affected infants are often very large at birth and may have macroglossia and organ enlargement. Frontiers+1

12. Other syndromic overgrowth disorders
    Syndromes such as Simpson–Golabi–Behmel and Costello syndrome can feature hyperinsulinism, probably due to abnormal growth signaling in pancreatic beta cells. In these children, CHI is part of a broader pattern of congenital anomalies. Frontiers+1

13. Perinatal stress hyperinsulinism
    Some newborns who have birth asphyxia, severe preeclampsia, or growth restriction develop transient hyperinsulinism. The stressed placenta and low oxygen state can change beta-cell function, causing high insulin levels that usually improve over time. SpringerLink+1

14. Maternal diabetes and high intrauterine glucose
    When a mother has poorly controlled diabetes in pregnancy, the fetus is exposed to high blood sugar. The fetal pancreas responds by making extra insulin and beta-cell mass, which can continue as hyperinsulinism and hypoglycemia after birth. UpToDate+1

15. Intrauterine growth restriction (IUGR)
    Babies who are small for gestational age due to placental insufficiency may develop transient CHI. The exact mechanism is complex, but changes in placental and fetal hormone levels seem to “reset” beta-cell responses and increase insulin secretion after birth. Frontiers+1

16. Pancreatic beta-cell hyperplasia (nesidioblastosis)
    Diffuse enlargement and increased number of beta cells in the pancreas, historically called nesidioblastosis, is a structural cause of CHI. This often reflects underlying genetic defects but may be described as a histological cause. fortuneonline.org+1

17. Focal pancreatic lesions with paternal mutation and somatic loss
    In focal CHI, a small region of beta cells carries a paternally inherited ABCC8 or KCNJ11 mutation plus loss of the maternal 11p15 region. This two-hit process creates a “patch” of overactive insulin-secreting cells that causes severe hypoglycemia. PMC+1

18. Mutations in less common HI-related genes
    Studies continue to identify new genes linked to CHI, including KDM6A and others. These rare variants show that many cellular pathways, from chromatin regulation to mitochondrial function, can ultimately disturb insulin release in beta cells. SpringerLink+1

19. Unknown or idiopathic genetic causes
    In a significant number of children with typical CHI, genetic testing finds no known mutation. These cases are called idiopathic. Researchers believe there are further undiscovered genes and regulatory defects that still cause abnormal insulin secretion. Frontiers+1

20. Combination of genetic and environmental factors
    For some babies, both inherited gene changes and environmental factors such as perinatal stress may act together. A mild genetic variant might not cause disease alone, but when combined with birth complications, it can push beta cells into over-secretion. Frontiers+1

Symptoms of congenital hyperinsulinemia

1. Recurrent low blood sugar (hypoglycemia)
   The core symptom of CHI is repeated episodes of low blood sugar. Babies may be diagnosed because routine checks show low glucose, or because they appear unwell or have seizures. Low sugar is dangerous because the brain depends mainly on glucose for energy. National Organization for Rare Disorders+1

2. Lethargy and poor responsiveness
   Infants with hypoglycemia from CHI often look “floppy,” sleepy, or difficult to wake. Parents may notice that the baby is less active than usual and seems uninterested in the environment, reflecting the brain’s lack of fuel. MedlinePlus+1

3. Irritability and abnormal crying
   Some babies are extremely fussy, cry with a high-pitched sound, or cannot be soothed. These signs can be subtle and may be mistaken for normal newborn behavior, but in CHI they often coincide with low blood sugar episodes. Wikipedia+1

4. Poor feeding or difficulty feeding
   Feeding problems are very common. Babies may not wake for feeds, may have weak sucking, or may suddenly demand very frequent feeds to keep blood sugar up. This pattern is a key clue in the early recognition of CHI. MedlinePlus+1

5. Jitteriness and tremors
   Low blood sugar stimulates the release of stress hormones like adrenaline. This can cause jitteriness, shakiness of the arms and legs, and fine tremors, which are often noticed by parents or nurses during hypoglycemic attacks. Wikipedia+1

6. Seizures (convulsions)
   If hypoglycemia is severe or prolonged, seizures can occur. These may look like jerking, stiffening, or unusual eye movements. Seizures are one of the most serious complications because they signal acute brain stress from lack of glucose. National Organization for Rare Disorders+1

7. Abnormal breathing or apnea
   Some infants with CHI develop rapid breathing, irregular breathing, or episodes where they stop breathing (apnea) during low sugar episodes. This may reflect both brain dysfunction and stress responses to hypoglycemia. Wikipedia+1

8. Changes in heart rate
   Hypoglycemia can cause a fast heart rate (tachycardia) or sometimes a slow rate (bradycardia). These changes are part of the body’s attempt to respond to energy crisis and may be seen on monitoring in the nursery or intensive care unit. Wikipedia+1

9. Sweating and paleness
   Cold sweats and pale skin are common during low blood sugar attacks. They are caused by activation of the sympathetic nervous system and reduced blood flow to the skin as the body tries to protect vital organs. National Organization for Rare Disorders+1

10. Low body temperature (hypothermia)
    Because glucose is needed to generate heat, babies with untreated CHI may have low body temperature. They may feel cool to touch or have unstable temperatures on monitoring in the hospital. Wikipedia+1

11. Low muscle tone (hypotonia)
    Many infants with CHI appear floppy, with poor head control and weak movements, especially during or after hypoglycemic spells. This low tone reflects reduced brain function and can improve when blood sugar is stabilized. Wikipedia+1

12. Large birth weight (macrosomia) in some types
    Babies with certain genetic forms of CHI or with maternal diabetes exposure may be unusually large at birth. High insulin levels in the womb act like a growth factor, so these infants have increased fat and muscle mass. Orpha.net+1

13. Developmental delay and learning problems
    If CHI is not recognized early or blood sugar is not kept stable, repeated brain injury from hypoglycemia can lead to long-term problems. Children may have delayed milestones, learning difficulties, or behavioral issues later in life. Frontiers+1

14. Visual and motor impairments
    Some children with a history of severe neonatal CHI develop visual impairment, motor coordination problems, or cerebral palsy-like symptoms, again due to early insults to the developing brain from prolonged low glucose. Frontiers+1

15. Coma in extreme cases
    In the most severe, untreated episodes, blood sugar may fall so low that the child becomes unresponsive and comatose. This is a life-threatening emergency and underlines why early diagnosis and strict control of hypoglycemia are vital in CHI. UpToDate+1

Diagnostic tests for congenital hyperinsulinemia

1. Detailed physical examination
   A full physical exam looks for signs such as large birth size, abdominal organ enlargement, tongue enlargement, or dysmorphic features that suggest syndromic CHI. Doctors also assess hydration, breathing, and overall appearance to judge how sick the baby is. Children’s Hospital of Philadelphia+1

2. Neurological examination
   The neurological exam checks tone, reflexes, alertness, and seizure activity. Abnormal findings such as hypotonia, poor reflexes, or seizure patterns can suggest that hypoglycemia has already affected the brain and guide urgent treatment. Frontiers+1

3. Vital signs monitoring
   Continuous or frequent monitoring of heart rate, breathing rate, blood pressure, and temperature helps detect stress responses during hypoglycemia. Sudden changes in these vital signs can alert staff to silent low blood sugar episodes. SpringerLink+1

4. Anthropometric and syndrome feature assessment
   Measuring weight, length, head size, and looking for features such as macroglossia or limb asymmetry helps identify conditions like Beckwith–Wiedemann syndrome or other overgrowth disorders linked to CHI, which has implications for genetics and cancer screening. Frontiers+1

5. Bedside blood glucose testing
   Frequent heel-stick tests or continuous glucose monitoring are used to document low blood sugar episodes. In CHI, glucose often remains low despite normal feeding or intravenous glucose infusion, suggesting abnormal insulin action. SpringerLink+1

6. “Critical sample” during hypoglycemia
   When glucose is low, doctors draw a “critical sample” of blood to measure insulin, C-peptide, ketones, free fatty acids, and other hormones. In CHI, insulin is inappropriately detectable or high, while ketones and free fatty acids are suppressed, showing strong insulin action. SpringerLink+1

7. Supervised fasting test
   In older infants and children, a controlled fast in hospital helps assess how quickly hypoglycemia appears and at what glucose level insulin remains inappropriately high. This test is done with close monitoring to avoid severe events and helps confirm hyperinsulinism. SpringerLink+1

8. Glucagon stimulation test
   Glucagon, a hormone that raises blood sugar, is injected during hypoglycemia. A large jump in glucose after glucagon indicates that insulin has been suppressing glucose release from the liver, which is typical of CHI rather than other causes of low sugar. SpringerLink+1

9. Trial of diazoxide therapy
   Diazoxide is the first-line drug for many forms of CHI. A clinical “trial” of diazoxide helps both treat and classify the disease. Patients who respond often have diazoxide-sensitive genetic forms, while non-responders frequently have KATP channel mutations requiring other therapies. PMC+1

10. Plasma insulin, C-peptide, and proinsulin levels
    Lab measurement of insulin and related peptides during hypoglycemia is central to diagnosis. In CHI, these hormones are inappropriately present or elevated when blood sugar is low, distinguishing hyperinsulinism from conditions with low or absent insulin. Medscape+1

11. Ketone bodies and free fatty acids
    In normal fasting, ketones and free fatty acids rise as the body switches to fat burning. In CHI, high insulin blocks this switch, so ketones (such as β-hydroxybutyrate) and free fatty acids remain low even when glucose is low, strongly suggesting hyperinsulinism. SpringerLink+1

12. Serum cortisol and growth hormone
    These hormones are measured to rule out other causes of hypoglycemia. In CHI, cortisol and growth hormone are usually normal or high, showing that the body is trying to correct low sugar, while insulin is inappropriately high. Medscape+1

13. Metabolic screening (lactate, ammonia, acylcarnitines, organic acids)
    Tests for lactate, ammonia, blood acylcarnitines, and urine organic acids help exclude other metabolic disorders such as fatty acid oxidation defects or organic acidemias. In GLUD1-related CHI, ammonia is often elevated, which supports that specific diagnosis. SpringerLink+1

14. Comprehensive genetic testing panel for HI genes
    Next-generation sequencing panels or whole-exome testing are used to look for mutations in ABCC8, KCNJ11, GLUD1, GCK, HADH, HNF4A, HNF1A, and many other genes. Finding a mutation can guide treatment decisions, predict diazoxide response, and identify whether the disease is focal or diffuse. NCBI+1

15. Methylation and imprinting studies for Beckwith–Wiedemann and 11p15
    Specialized tests examine methylation patterns and copy number changes at chromosome 11p15. These studies help diagnose Beckwith–Wiedemann syndrome and also support the diagnosis of focal CHI when paternal mutations and somatic changes are involved. Frontiers+1

16. Electroencephalogram (EEG)
    EEG records the brain’s electrical activity and is used in CHI to detect and classify seizures due to hypoglycemia. It can show abnormal patterns even when seizures are not obvious clinically, guiding anti-seizure treatment and helping measure brain injury. Frontiers+1

17. Continuous video EEG monitoring
    In very sick infants with frequent spells, prolonged video EEG helps capture subtle seizures and relate them to glucose levels. This allows the team to adjust glucose and medications to prevent further brain damage from unrecognized hypoglycemic seizures. Frontiers+1

18. 18F-DOPA positron emission tomography (PET) / CT scan of the pancreas
    18F-DOPA PET/CT is a key imaging test in CHI. It shows areas of increased uptake in focal lesions and more uniform uptake in diffuse disease. This information helps surgeons plan limited focal resections instead of near-total pancreatectomy when possible. PMC+1

19. Abdominal ultrasound of the pancreas and organs
    Ultrasound is a non-invasive imaging tool to look at the pancreas and abdominal organs. It can help rule out structural masses, assess organ size in overgrowth syndromes, and guide further imaging, although it is less sensitive than PET for focal CHI. Children’s Hospital of Philadelphia+1

20. Magnetic resonance imaging (MRI) or CT of brain and pancreas
    MRI or CT of the brain is used to look for hypoglycemia-related brain injury, such as white matter damage. MRI or CT of the pancreas may also be done when PET is not available or to supplement PET findings, helping surgeons understand anatomy before surgery. PMC+1

Non-Pharmacological Treatments (Therapies and Other Measures)

(These measures support, but do not replace, specialist medical care. They must always be planned by a pediatric endocrinology team.)

1. Continuous Intravenous Dextrose Infusion
In acute severe hypoglycemia, doctors give concentrated glucose (dextrose) directly into a vein as a bolus, followed by continuous infusion. This quickly raises and then maintains blood sugar at a safe level while the team works out diagnosis and long-term treatment. The purpose is emergency brain protection; the mechanism is simple: dextrose directly supplies glucose to the blood faster than the pancreas can lower it.PMC+2Dove Medical Press+2

2. Frequent High-Carbohydrate Feeds
Many babies and children with CHI need very frequent feeds (for example every 2–3 hours) with milk or formula that contains enough carbohydrate. The purpose is to prevent long fasting gaps. The mechanism is to give a steady stream of glucose from the gut, so that even if insulin is high, blood sugar stays closer to normal between feeds.SpringerLink+2gosh.nhs.uk+2

3. Continuous Enteral Feeding via NG or Gastrostomy Tube
If a child cannot drink enough or needs constant glucose, a thin tube into the stomach (nasogastric or gastrostomy) can deliver formula or dextrose 24 hours a day. The purpose is to maintain stable blood sugar when oral feeding alone is not enough. The mechanism is continuous carbohydrate absorption from the intestine, which helps balance the constant insulin release.PMC+2Children’s Hospital of Philadelphia+2

4. Night-Time Drip Feeds
Some children do not need feeds all day but become hypoglycemic overnight. Night-time tube feeds give a slow, steady supply of carbohydrate while the child sleeps. The purpose is to extend safe fasting time. The mechanism is similar to continuous feeding but limited to the highest-risk time, when the child is not awake to show symptoms.Children’s Hospital of Philadelphia+2SpringerLink+2

5. Emergency Oral Fast-Acting Glucose
Glucose gel, sugary drinks, or other fast-acting carbohydrates are used at the first sign of mild hypoglycemia in children who can safely swallow. The purpose is to quickly raise blood sugar at home or school before it drops further. The mechanism is rapid absorption of simple sugars through the gut into the bloodstream.National Organization for Rare Disorders+2Congenital Hyperinsulinism International+2

6. Uncooked Cornstarch or Slow-Release Carbohydrate
In some older children, dietitians may use uncooked cornstarch or special modified starch at bedtime. These starches break down slowly and provide a long “tail” of glucose overnight. The purpose is to reduce early-morning hypoglycemia and improve sleep. The mechanism is delayed digestion and gradual glucose release.ScienceDirect+3PMC+3Medscape+3

7. Structured Meal Plans by a Metabolic Dietitian
A specialist dietitian creates an individualized meal plan that matches carbohydrate intake, feeding schedule, and child’s growth needs. The purpose is to balance safe blood sugar with healthy weight and development. The mechanism is careful calculation of carbohydrate per meal and per day, with limits on fasting times based on the child’s response.PMC+2gosh.nhs.uk+2

8. Home Blood Glucose Monitoring
Parents are trained to check blood sugar with a finger-stick meter at set times (for example before feeds, overnight, or when symptoms appear). The purpose is early detection of low blood sugar outside the hospital. The mechanism is simple point-of-care measurement that guides immediate feeding or emergency treatment.PMC+2Congenital Hyperinsulinism International+2

9. Continuous Glucose Monitoring (CGM)
Some centers use CGM devices that track glucose in the tissue fluid almost continuously. Alarms can alert caregivers to falling glucose during sleep or play. The purpose is to reduce silent or unrecognized hypoglycemia. The mechanism is a tiny sensor under the skin sending frequent readings to a receiver or smartphone.SpringerLink+2Dove Medical Press+2

10. Written Emergency Plans for Home and School
Families receive clear written instructions on what to do when blood sugar is low, including when to give fast-acting sugar, when to use glucagon, and when to call emergency services. Schools and caregivers follow the same plan. The purpose is to standardize safe responses. The mechanism is preparation and education before a crisis happens.Congenital Hyperinsulinism International+2Cureus+2

11. Parental and Caregiver Education Programs
Education covers recognizing symptoms, checking glucose, giving emergency treatment, and storing medicines. The purpose is to make families confident partners in care. The mechanism is repeated teaching, practice (often with apps or dummy kits), and easy-to-read information sheets.Congenital Hyperinsulinism International+2Glucagon Emergency Kit+2

12. Avoiding Prolonged Fasting (Including Before Procedures)
Children with CHI should not fast for long periods. Before surgery or scans, hospital teams use special protocols with dextrose infusions or early feeds. The purpose is to prevent dangerous drops in blood sugar during fasting. The mechanism is careful timing of IV dextrose and feeds to cover the no-oral-intake period.PMC+2Karger Publishers+2

13. Temperature and Illness Management
Fever, vomiting, or poor intake can increase the risk of hypoglycemia. Parents receive “sick day” rules that may include more frequent glucose checks, extra carbohydrate, and earlier hospital review. The purpose is to protect the child during stress. The mechanism is adjusting support when energy needs or intake change.Hopkins Medicine+2Cureus+2

14. Psychological and Family Support
CHI management is stressful. Psychological support, social work help, and peer support groups reduce anxiety and improve adherence to complex regimens. The purpose is to support mental health and family coping. The mechanism is counseling, group meetings, and online communities that share experiences and solutions.ResearchGate+1

15. Coordinated Multidisciplinary Care
Optimal care usually takes place in specialized CHI centers with endocrinologists, surgeons, dietitians, nurses, geneticists, and psychologists. The purpose is to bring all expertise together. The mechanism is regular joint meetings and shared protocols that improve consistency and outcomes.Frontiers+2Dove Medical Press+2

16. Genetic Counseling for Families
After genetic testing, counselors explain inheritance patterns, recurrence risk, and options for future pregnancies. The purpose is informed family planning and early detection in siblings. The mechanism is translating complex genetics into simple information and discussing choices with the family.jcrpe.org+2SpringerLink+2

17. Use of Specialized CHI Registries and Research Programs
Some families join registries or clinical studies to access emerging treatments and help improve knowledge. The purpose is better long-term understanding of CHI and more treatment options in the future. The mechanism is collecting standardized clinical data and linking patients with research centers.ResearchGate+2Children’s Hospital of Philadelphia+2

18. Transition Programs to Adult Care
As teenagers with CHI grow up, they move from pediatric to adult services. Structured transition programs teach self-management skills and help them navigate adult clinics. The purpose is to avoid gaps in care. The mechanism is stepwise transfer, joint clinics, and written transition plans.SpringerLink+1

19. Safety Planning for Travel and Activities
Families are advised to carry a glucose source, glucagon kit, and a letter from the specialist when travelling. Plans are made for school trips, sports, and holidays. The purpose is continuous safety in new environments. The mechanism is advance planning and communication with caregivers and local hospitals.Congenital Hyperinsulinism International+2Glucagon Emergency Kit+2

20. School and Community Education
Teachers, school nurses, and caregivers are taught basic CHI facts, symptoms of low blood sugar, and emergency steps. The purpose is quick recognition and treatment away from home. The mechanism is short training sessions, written instructions, and regular review of the child’s care plan.Congenital Hyperinsulinism International+1

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Drug Treatments

Important safety note: Doses for babies and children with congenital hyperinsulinism are highly specialized. Only a pediatric endocrinologist should decide exact drug, dose, and schedule. Below, “dosage” is described in general terms based on FDA labeling and published guidelines, not as instructions for home use.

1. Diazoxide (PROGLYCEM and generics)
Diazoxide is the first-line drug for many children with CHI. It opens potassium channels in beta cells, making them less likely to release insulin. The purpose is to reduce inappropriate insulin secretion and prevent hypoglycemia. The dose is calculated per kilogram and split into several doses per day, as guided by the FDA label and international guidelines. Side effects include fluid retention, heart failure in at-risk infants, hypertrichosis (extra hair), and risk of pulmonary hypertension.MDPI+4FDA Access Data+4FDA Access Data+4

2. Thiazide Diuretics (e.g., Chlorothiazide, Hydrochlorothiazide)
Thiazide diuretics are often added when diazoxide causes fluid retention and heart failure risk. They promote salt and water loss in the kidneys, helping control swelling and high blood pressure linked to diazoxide. Doses are weight-based and adjusted by the specialist. Side effects can include low sodium or potassium, dehydration, and effects on kidney function, so labs must be monitored.Frontiers+2list.essentialmeds.org+2

3. Octreotide (Sandostatin – short-acting)
Octreotide is a synthetic somatostatin analogue used when diazoxide does not work or cannot be tolerated. It blocks the release of insulin from beta cells and also slows gut hormone release. It is given by subcutaneous injection several times per day or by continuous infusion. Side effects include digestive upset, gallstones, altered glucose tolerance, and possible growth effects.SpringerLink+3FDA Access Data+3FDA Access Data+3

4. Long-Acting Octreotide (Sandostatin LAR Depot)
Long-acting octreotide is given as a deep intramuscular injection every few weeks. In some older children or long-term cases, it reduces the burden of daily injections. The purpose and mechanism are the same as short-acting octreotide—sustained blockade of insulin release—but with prolonged effect. The dose is chosen according to adult labeling and adjusted carefully in children. Side effects mirror short-acting octreotide, with added injection-site pain.SpringerLink+3FDA Access Data+3FDA Access Data+3

5. Lanreotide (Somatuline Depot and similar lanreotide injections)
Lanreotide is another long-acting somatostatin analogue. It is licensed by the FDA for acromegaly and certain neuroendocrine tumors but has been used off-label in CHI when diazoxide and octreotide are not suitable. It is injected deeply under the skin every 4 weeks. Side effects include gastrointestinal problems and gallstones. Use in CHI is specialist-only and based on case reports and extrapolation from approved indications.ResearchGate+3FDA Access Data+3FDA Access Data+3

6. Glucagon (Emergency Injection Kits and Infusions)
Glucagon is a natural hormone that raises blood sugar by telling the liver to release stored glucose. It is used as an emergency injection for severe hypoglycemia at home, and as continuous infusion in hospital for some CHI patients. Glucagon kits are FDA-approved for severe hypoglycemia. Typical side effects are nausea and vomiting; rare side effects include allergic reactions. It is a rescue therapy, not a long-term cure.Children’s Health Ireland+4FDA Access Data+4FDA Access Data+4

7. Intravenous Dextrose Solutions (e.g., 10–50% Dextrose)
Dextrose solutions are drugs in the sense that they are regulated injectable medicines. In CHI, high-concentration dextrose via central venous catheter may be required to deliver enough glucose without fluid overload. The purpose is to maintain safe glucose until other measures control insulin secretion. Side effects include vein irritation, electrolyte changes, and risk of line infection.Karger Publishers+2ScienceDirect+2

8. Sirolimus (Rapamune – highly selected, off-label)
Sirolimus is an mTOR inhibitor approved by the FDA as an immunosuppressant in kidney transplantation, but has been tried in small series of children with extremely severe, diazoxide-unresponsive CHI. It seems to reduce insulin secretion by affecting beta-cell signaling. Dosing is very complex and guided by blood levels. Side effects are serious and include infection risk, mouth ulcers, high lipids, and potential malignancy risk, so most guidelines advise extreme caution.Pure Manchester+4FDA Access Data+4FDA Access Data+4

9. Everolimus (Afinitor – experimental in CHI)
Everolimus, another mTOR inhibitor approved for tumors such as tuberous sclerosis–related SEGA, has similar mechanisms to sirolimus. Some centers have explored it for refractory CHI, again only in complex specialist settings. The drug suppresses cell growth and may reduce insulin release, but immunosuppression and infection, mouth ulcers, and metabolic side effects limit its use. It is not standard CHI therapy and should only be used within strict protocols or trials.Pure Manchester+3FDA Access Data+3FDA Access Data+3

10. Calcium Channel Blockers (e.g., Nifedipine – rare and limited evidence)
Nifedipine is a calcium channel blocker used mainly for blood pressure. Small reports have described its use in CHI to reduce calcium influx in beta cells and thereby decrease insulin secretion. Evidence is weak, and international guidelines now rarely recommend it. Possible side effects include low blood pressure, fast heart rate, and swelling. Any use is off-label and experimental.Semantic Scholar+2ResearchGate+2

11. Emerging Glucagon-Like Drugs (e.g., investigational analogues)
Research is ongoing into long-acting glucagon analogues, such as molecules designed to mimic glucagon with once-weekly injections. Early studies in CHI suggest they might help reduce hypoglycemia by providing a stable counter-hormone effect. These drugs are still under study and not yet routine. Side effects and best dosing are being investigated in trials.Children’s Hospital of Philadelphia+1

12. Supportive Medicines Around Surgery and Critical Care
Children with CHI who undergo major surgery or have central lines may receive antibiotics, proton-pump inhibitors, and pain medicines as part of comprehensive care. These do not treat hyperinsulinism directly, but support safe treatment and recovery. Side effects depend on the medicine and are carefully monitored by the hospital team.Frontiers+2Hopkins Medicine+2

(In practice, diazoxide, thiazides, somatostatin analogues, glucagon, and dextrose are the main medicines used for congenital hyperinsulinemia; others are reserved for highly selected or research situations.)

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Dietary Molecular Supplements

These supplements do not replace medical treatment. Always discuss any supplement with the child’s specialist, because some can interfere with medicines or blood sugar.

1. Uncooked Cornstarch (Special Medical Products)
Uncooked cornstarch and specially modified starch products are sometimes used at night in older children to give a slow, steady source of glucose. The dietitian calculates the amount based on weight and response tests. The function is to extend safe fasting time; the mechanism is delayed digestion and gradual release of glucose into the blood over many hours.Medscape+2ajcn.nutrition.org+2

2. Complex Carbohydrate Additives (e.g., Maltodextrin)
Maltodextrin or other complex carbohydrate powders can be added to formula or food to increase carbohydrate density when volume tolerance is low. The dose is set by the dietitian. The function is to raise total carbohydrate intake without overfeeding fluid. The mechanism is providing extra glucose precursors for absorption.PMC+2ScienceDirect+2

3. Balanced Pediatric Multivitamin
Children on restricted or highly structured diets may receive a multivitamin supplement. The typical dose follows age-appropriate recommendations. The function is to prevent vitamin deficiencies that might affect growth and immune function. The mechanism is simply replacing micronutrients that may be missing from a limited or tube-based diet.SpringerLink+1

4. Vitamin D and Calcium Supplements
Because some CHI medicines (like diuretics or steroids when used) and limited outdoor activity can affect bone health, vitamin D and calcium may be recommended. Doses follow pediatric bone-health guidelines. The function is to support normal bone mineralization; the mechanism is improved calcium absorption and bone remodeling.SpringerLink+2Semantic Scholar+2

5. Omega-3 Fatty Acids (Fish Oil)
Omega-3 supplements may be used for overall cardiovascular and anti-inflammatory benefits, especially when children receive mTOR inhibitors that can raise blood lipids. The dose is based on weight and product content. The function is lipid profile support; the mechanism is modulation of cell membrane function and inflammatory pathways.New England Journal of Medicine+2FDA Access Data+2

6. Probiotics
Children receiving long-term tube feeds or multiple medications may have disturbed gut flora. Probiotics may be considered to improve stool pattern and gut comfort. The dose and strain are chosen by the team. The function is gastrointestinal support; the mechanism is restoring a healthy balance of bacteria in the gut.SpringerLink+1

7. Medium-Chain Triglyceride (MCT)-Enriched Formulas
MCT-rich formulas are sometimes used when fat absorption is an issue or extra calories are needed without more volume. The dose is tailored by dietitians. The function is high-energy nutrition; the mechanism is easier digestion and rapid absorption of MCTs, helping maintain weight and energy balance.Nature+1

8. Electrolyte Supplements (e.g., Sodium, Potassium)
When children use diuretics with diazoxide or have high dextrose infusions, electrolytes may become unbalanced. Supplements correct specific deficits. Doses are individualized from blood tests. Their function is maintaining safe heart and muscle function; the mechanism is direct replacement of missing ions.list.essentialmeds.org+2Frontiers+2

9. Protein-Rich Oral Nutrition Products
Some children with CHI are underweight or have feeding aversion. High-protein drinks or powders may be used in addition to carbohydrates. The function is to support growth and tissue repair; the mechanism is providing extra amino acids and calories in a small volume.SpringerLink+2Dove Medical Press+2

10. Individualized Micronutrient Replacement (Iron, B12, Folate, etc.)
If testing shows specific deficiencies (for example, iron-deficiency anemia), targeted supplements may be prescribed. The dose follows pediatric guidelines. The function is to correct the deficiency and improve energy, growth, or blood counts. The mechanism depends on the nutrient—for example, iron supports red blood cell formation.SpringerLink+2Hopkins Medicine+2

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Immunity-Booster, Regenerative, and Stem-Cell-Related Drugs

Very important: There are no FDA-approved “immunity booster” or stem-cell drugs specifically for congenital hyperinsulinemia. The medicines below are discussed only to explain research directions and related care.

1. Sirolimus as a Beta-Cell Modulator (Not an Immunity Booster)
Sirolimus is actually an immunosuppressant, not an immunity booster. In severe CHI, it has been used off-label to reduce insulin secretion via mTOR inhibition in beta cells. The function in CHI is to dampen overactive insulin-producing cells. The mechanism is blocking mTOR signaling, which affects cell growth and secretion. Because it weakens the immune system and has many risks, it is reserved for the most severe cases under strict supervision.Pure Manchester+4New England Journal of Medicine+4ResearchGate+4

2. Everolimus as an mTOR Pathway Drug
Everolimus is another mTOR inhibitor used mainly for tumors. In theory, it could modulate beta-cell activity similarly to sirolimus, and it has been explored in rare, complex CHI settings. The function would be to reduce inappropriate insulin secretion. The mechanism again is mTOR pathway blockage. However, it carries immunosuppression, mouth ulcers, and metabolic side effects, and is not standard care.Pure Manchester+3FDA Access Data+3FDA Access Data+3

3. Experimental Long-Acting Glucagon Analogues
New biologic drugs that act like long-lasting glucagon are being studied in CHI. They do not regenerate tissue but may reduce hypoglycemia episodes by sustaining a stable glucose-raising hormone level. The mechanism is continuous stimulation of hepatic glucose production and glycogen breakdown. These products are still in clinical trials.Children’s Hospital of Philadelphia+2ResearchGate+2

4. Pancreatic Islet Transplant Concepts (Experimental for CHI)
In theory, transplanting healthy insulin-producing islet cells or gene-corrected cells could one day help selected CHI patients, especially after near-total pancreatectomy. At present this is experimental and mostly theoretical for CHI. The function would be to restore more normal insulin secretion; the mechanism would involve engrafting functional beta cells, often requiring lifelong immunosuppression.SpringerLink+2Frontiers+2

5. Gene-Targeted Therapies Under Investigation
Future regenerative approaches may involve gene editing or gene replacement to correct mutations in KATP channel genes. These are not yet available as treatments. The function would be to correct the root cause at DNA level; the mechanism might use viral vectors or genome-editing tools to restore normal channel function. Safety and long-term effects are still under study.jcrpe.org+2ResearchGate+2

6. General Immune Health Support (Vaccination and Standard Care)
Although not a specific “drug for immunity,” routine childhood vaccines, good nutrition, and prompt infection management are critical, especially for children on immunosuppressants like sirolimus. The function is to reduce the risk of serious infection in vulnerable patients. The mechanism is priming the immune system with vaccines and maintaining general health so the child can safely continue CHI treatment.FDA Access Data+2FDA Access Data+2

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Surgical Treatments and Procedures

1. Focal Lesionectomy (Removal of Focal Pancreatic Lesion)
If imaging such as 18F-DOPA PET shows a focal area of abnormal insulin-producing cells, surgeons can remove just that small part of the pancreas. The purpose is to cure CHI while preserving as much normal pancreatic tissue as possible. The mechanism is simple: taking out the abnormal cluster that is driving excess insulin. Many children are effectively cured with this approach.SpringerLink+2SpringerLink+2

2. Partial (Subtotal) Pancreatectomy
In diffuse CHI that does not respond to maximal medical therapy, a large portion of the pancreas may be removed. The purpose is to reduce the total number of insulin-secreting cells. The mechanism is decreasing insulin-producing mass so that hypoglycemia becomes less severe, but later diabetes and exocrine insufficiency are common risks. Decisions are made only in experienced CHI centers.Wikipedia+3SpringerLink+3Semantic Scholar+3

3. Near-Total Pancreatectomy
Some children with severe diffuse CHI require removal of almost all the pancreas. The purpose is last-resort control of life-threatening hypoglycemia that cannot be controlled otherwise. The mechanism is maximal reduction of beta-cell mass. Long-term, many patients develop insulin-dependent diabetes and need enzyme replacement, so this option is chosen very carefully.SpringerLink+2Semantic Scholar+2

4. Placement of Gastrostomy Tube (G-Tube)
A gastrostomy tube is a surgical feeding tube placed directly into the stomach through the abdominal wall. The purpose is to allow safe, reliable continuous or overnight feeds when nasogastric tubes are not practical or long-term. The mechanism is simple mechanical access to the stomach, improving comfort and security of feeding.PMC+2Children’s Hospital of Philadelphia+2

5. Central Venous Line Placement for Long-Term Dextrose
Children who need high-concentration dextrose that cannot go through peripheral veins may require a central venous catheter. The purpose is long-term safe delivery of dextrose and other IV drugs. The mechanism is placing a catheter into a large central vein. Risks include infection and clotting, so strict care protocols are vital.ScienceDirect+2Dove Medical Press+2

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Prevention and Risk Reduction

1. Early recognition of neonatal hypoglycemia in at-risk babies (prematurity, growth restriction, syndromes) and immediate glucose testing and treatment.Hopkins Medicine+1

2. Rapid referral to specialized CHI centers when hypoglycemia is persistent or severe.Frontiers+1

3. Strict avoidance of prolonged fasting, with clear feeding schedules and sick-day rules.Karger Publishers+1

4. Adherence to prescribed medicines like diazoxide and somatostatin analogues, with regular review for side effects.Semantic Scholar+1

5. Routine home glucose monitoring and, when available, use of CGM and alarms.SpringerLink+1

6. Parental and school education so that any symptoms of low blood sugar are acted on quickly.Congenital Hyperinsulinism International+1

7. Up-to-date vaccinations and infection control, especially if immunosuppressive drugs are used.FDA Access Data+2FDA Access Data+2

8. Regular developmental and neurological follow-up to detect and support any learning or movement problems early.Semantic Scholar+1

9. Genetic testing and counseling for families to inform future pregnancies and early monitoring of siblings.jcrpe.org+2SpringerLink+2

10. Participation in standardized protocols and, when suitable, research studies, which helps optimize and personalize care over time.Frontiers+2ResearchGate+2

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When to See a Doctor Urgently

Parents and caregivers should seek immediate emergency care if a child with known or suspected congenital hyperinsulinism has any of the following:

• Very low blood sugar on the meter or test strip, especially if below the target set by the specialist.PMC+1

• Symptoms such as shakiness, sweating, pale or blue color, fast heartbeat, unusual sleepiness, irritability, or sudden behavior changes.Semantic Scholar+1

• More serious signs like seizures, loss of consciousness, poor breathing, or inability to swallow.Hopkins Medicine+1

• Persistent vomiting, poor feeding, or high fever that prevents normal eating.Hopkins Medicine+1

• Any concern that medicines (for example diazoxide, sirolimus, octreotide) are causing breathing problems, severe swelling, or signs of infection.FDA Access Data+3Dove Medical Press+3FDA Access Data+3

For routine follow-up, families should see the CHI team regularly for growth checks, development assessment, medication review, and adjustment of feeding plans.

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What to Eat and What to Avoid

1. Eat regular meals and snacks rich in complex carbohydrates, such as rice, pasta, bread, potatoes, and cereals, spaced according to the plan from the dietitian.gosh.nhs.uk+1

2. Include balanced protein and healthy fats (meat, fish, eggs, dairy, beans, nut butters when age-appropriate) to support growth and stable energy.SpringerLink+1

3. Use slow-release carbohydrate options (e.g., cornstarch-based products when prescribed) at night for older children to reduce fasting risk.Medscape+2ajcn.nutrition.org+2

4. Avoid long gaps without food, especially overnight or during long trips; always carry snacks and a source of fast sugar.Dove Medical Press+2Karger Publishers+2

5. Limit very high-sugar, low-nutrient foods (like candies and sugary drinks) except when used specifically as emergency treatment for low blood sugar.Dove Medical Press+1

6. Avoid crash diets, weight-loss fads, or extended fasting, which can be dangerous for anyone with a history of CHI or hypoglycemia.SpringerLink+1

7. Avoid alcohol in older teenagers and adults with a CHI history, as alcohol can blunt the liver’s ability to release glucose.Dove Medical Press+1

8. Use specialized formulas or tube-feeding recipes exactly as prescribed; do not dilute or concentrate feeds without guidance.PMC+2Children’s Hospital of Philadelphia+2

9. Check labels for carbohydrate content when introducing new packaged foods, and discuss major diet changes with the CHI team.PMC+1

10. Avoid over-the-counter supplements or herbal products that claim to “boost insulin” or “lower blood sugar,” because they can worsen hypoglycemia in CHI. Always ask the specialist first.Semantic Scholar+2FDA Access Data+2

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Frequently Asked Questions (FAQs)

1. Is congenital hyperinsulinemia the same as diabetes?
No. In diabetes, there is too little effective insulin, leading to high blood sugar. In congenital hyperinsulinemia, there is too much insulin, causing low blood sugar. Both conditions involve the pancreas and insulin, but they are almost opposite problems and need very different treatments.Semantic Scholar+1

2. Can a child with CHI live a normal life?
With early diagnosis, careful treatment, and close follow-up, many children with CHI grow and develop well and attend school like other children. The biggest risk is repeated severe hypoglycemia early in life. Good glucose control and regular neurological checks help protect long-term outcomes.PMC+2Semantic Scholar+2

3. Will my child always need medicine?
It depends on the cause of CHI. Some forms improve over time, especially transient hyperinsulinism related to perinatal stress, and medicines may eventually be stopped. Other genetic forms can be lifelong. The CHI team uses genetics, imaging, and clinical response to decide how long treatment should continue.Hopkins Medicine+2jcrpe.org+2

4. How is CHI diagnosed?
Doctors look at blood tests taken during hypoglycemia: low glucose, inappropriately high insulin, low ketones and free fatty acids, and response to glucagon. Genetic tests and specialized scans, such as 18F-DOPA PET, help distinguish focal from diffuse disease and guide surgery decisions.SpringerLink+3PMC+3Frontiers+3

5. Why is diazoxide often the first drug used?
International guidelines and large studies show that diazoxide is currently the only widely approved medicine specifically recommended as first-line therapy for hyperinsulinism in many children. It works directly on pancreatic KATP channels to reduce insulin release. Its benefits and risks are well known, so teams can monitor and manage side effects.ResearchGate+2list.essentialmeds.org+2

6. What happens if diazoxide does not work?
If blood sugar remains low despite maximal safe diazoxide and thiazide support, doctors often move to somatostatin analogues like octreotide or lanreotide, add continuous feeding, and consider genetic and imaging results. In very severe cases, sirolimus or surgery may be discussed. The goal is always to protect the brain while minimizing long-term harm.Wiley Online Library+3Semantic Scholar+3ResearchGate+3

7. Are drugs like sirolimus safe for children with CHI?
Sirolimus has helped some children with extremely severe, treatment-resistant CHI, but it has significant risks such as infections, mouth ulcers, lipid abnormalities, and possible long-term cancer risk. Current expert reviews encourage extreme caution and usually reserve it for selected cases, often in research settings.FDA Access Data+3New England Journal of Medicine+3Pure Manchester+3

8. Can diet alone control congenital hyperinsulinemia?
Diet and feeding schedules are very important but usually not enough on their own for most CHI types. Medicines, and sometimes surgery, are often needed in addition to careful nutrition to keep blood sugar in a safe range and avoid brain injury.gosh.nhs.uk+2SpringerLink+2

9. Will my child develop diabetes later if part of the pancreas is removed?
After partial or near-total pancreatectomy, many patients later develop glucose intolerance or diabetes because there is not enough beta-cell mass left. They may need insulin injections or other diabetes treatments. This risk is one reason surgeons and families weigh pancreatectomy decisions very carefully.SpringerLink+2Semantic Scholar+2

10. How often should blood sugar be checked at home?
The CHI team sets an individualized plan. During unstable periods, checks may be needed many times per day and overnight. As control improves, the schedule may relax but still include key times like before feeds, during illness, and before long activities or travel. Continuous glucose monitoring may reduce the need for finger-sticks.Dove Medical Press+2SpringerLink+2

11. Can congenital hyperinsulinemia be prevented before birth?
In most cases, CHI cannot be fully prevented because it results from genetic changes that happen before birth. However, when a family mutation is known, prenatal counseling and early post-birth monitoring can reduce the risk of unrecognized hypoglycemia and brain injury.jcrpe.org+2SpringerLink+2

12. Is exercise safe for a child with CHI?
Exercise is usually encouraged for overall health, but it uses glucose and can increase the risk of hypoglycemia. The CHI team may recommend pre-exercise snacks, extra monitoring, and carrying fast-acting sugar. With a good plan and supervision, many children can safely participate in sports.Dove Medical Press+2Congenital Hyperinsulinism International+2

13. What about vaccinations and routine illnesses?
Children with CHI should follow routine vaccination schedules. During illness, they may need more frequent feeds and glucose checks, and sometimes hospital care for IV dextrose. If immunosuppressive drugs are used, infection risk is higher and the team may adjust vaccine timing or type.Hopkins Medicine+2FDA Access Data+2

14. Can siblings also have CHI?
Yes. Many forms of CHI are inherited in recessive or dominant patterns. Once a mutation is identified in one child, genetic counseling can estimate the risk to brothers, sisters, and future pregnancies, and early monitoring can be arranged.jcrpe.org+2SpringerLink+2

15. Is online information enough to manage CHI?
No. Congenital hyperinsulinemia is complex and can be life-threatening without expert care. Online information can help families understand the condition and prepare questions, but only specialist doctors and multidisciplinary CHI teams can safely plan testing, medicines, feeds, and surgery. Always use online content as education, not as a substitute for medical advice.Frontiers+2PMC+2

Disclaimer: Each person’s journey is unique, treatment plan, life style, food habit, hormonal condition, immune system, chronic disease condition, geological location, weather and previous medical  history is also unique. So always seek the best advice from a qualified medical professional or health care provider before trying any treatments to ensure to find out the best plan for you. This guide is for general information and educational purposes only. Regular check-ups and awareness can help to manage and prevent complications associated with these diseases conditions. If you or someone are suffering from this disease condition bookmark this website or share with someone who might find it useful! Boost your knowledge and stay ahead in your health journey. We always try to ensure that the content is regularly updated to reflect the latest medical research and treatment options. Thank you for giving your valuable time to read the article.

The article is written by Team RxHarun and reviewed by the Rx Editorial Board Members

Last Updated: December o2 , 2025.