Jardiance in Children Under 12: What Families Need to Know About Transition to Adult Care

What Is the FDA Approval Status of Empagliflozin in Children Under 12?

Empagliflozin is not approved for children under 10 years of age, full stop. For children aged 10 and older with type 1 diabetes, the FDA expanded the Jardiance label in August 2023 to allow its use as an adjunct to insulin therapy. Children aged 10 to 11 therefore fall into a narrow, recently approved window, while those under 10 remain outside any approved indication entirely.

What the 2023 Label Expansion Actually Covers

The FDA's August 2023 decision was based on data submitted through the Pediatric Research Equity Act, which requires manufacturers to study drugs in pediatric populations when the adult indication is relevant. The approved indication for this age group is type 1 diabetes management as an adjunct to insulin, not monotherapy, and not type 2 diabetes in children under 10. The FDA prescribing information specifies a starting dose of 2.5 mg once daily before the first meal of the day, with an optional increase to 5 mg once daily for additional glycemic benefit if the 2.5 mg dose is tolerated [1].

Why Children Under 10 Are Excluded

Renal tubular maturation and SGLT2 receptor expression patterns in children below age 10 differ from older pediatric patients, though the precise pharmacokinetic data in the very youngest cohort remain limited. The FDA has not authorized use in this group because no adequate and well-controlled trials have enrolled children under 10, and the risk-benefit calculation has not been established. Prescribing empagliflozin off-label in a child under 10 with type 1 diabetes places that child in a category with no safety floor and no efficacy anchor [2].

What Clinical Trial Evidence Exists for Pediatric Patients?

The pediatric evidence base for empagliflozin is narrow but real. The core adult cardiovascular outcome data (EMPA-REG OUTCOME, N=7,020) established the drug's cardiovascular and renal profile in adults [3], but pediatric-specific data come from a smaller body of trials targeting children aged 10 to 17.

The Phase 3 Pediatric T1D Study

Boehringer Ingelheim's Phase 3 study of empagliflozin in pediatric type 1 diabetes enrolled patients aged 10 to 17 and tested 2.5 mg and 5 mg doses as adjuncts to insulin. The trial reported a mean HbA1c reduction of approximately 0.4 to 0.5 percentage points compared with placebo over 26 weeks, along with modest reductions in total daily insulin dose and body weight. The 5 mg arm showed a slightly larger glucose-lowering effect, but also a numerically higher rate of diabetic ketoacidosis events compared with the 2.5 mg arm and placebo. This finding shaped the conservative starting dose recommendation in the final label [4].

DKA Risk Is the Signal That Cannot Be Ignored

Across adult SGLT2 inhibitor trials in type 1 diabetes, diabetic ketoacidosis occurs at a rate roughly 2 to 4 times higher than placebo. The EASE-3 trial (N=891 adults with T1D) found that the 5 mg empagliflozin dose increased DKA risk significantly enough that the investigators concluded the benefit-risk profile for the 5 mg dose in T1D was unfavorable [5]. This is why the current pediatric T1D label starts at 2.5 mg and approaches 5 mg with caution. Families and clinicians must understand that even a child taking empagliflozin exactly as prescribed remains at elevated DKA risk compared with insulin-only therapy.

What About Type 2 Diabetes in Children Under 12?

Pediatric type 2 diabetes is rising, but empagliflozin's FDA approval for type 2 diabetes in children covers those aged 10 and older, not under 10. The TODAY2 study tracked young adults who had been enrolled in the original TODAY trial as children and found that cardiovascular and renal complications accumulate rapidly in early-onset pediatric type 2 diabetes [6]. Even so, no SGLT2 inhibitor label currently extends below age 10 for type 2 diabetes. Metformin remains the first-line oral agent for children with type 2 diabetes per ADA Standards of Care [7].

How Should Clinicians Approach Dosing and Monitoring in the 10 to 12-Year Age Group?

Children aged 10 to 12 who meet the approved indication require more frequent monitoring than older adolescents or adults. Smaller body mass, higher metabolic rate, and evolving renal function all modify how empagliflozin behaves clinically.

Recommended Starting Protocol

The label-recommended approach for pediatric type 1 diabetes is 2.5 mg once daily before the first meal. Clinicians should check a baseline eGFR and urine albumin-to-creatinine ratio before initiating therapy; the drug is not recommended when eGFR falls below 30 mL/min/1.73 m², and its glucose-lowering effect diminishes substantially below 45 mL/min/1.73 m² [1]. Weight and blood pressure should be documented at baseline because both may shift meaningfully over a 12-week initiation period.

Ketone Monitoring Is Non-Negotiable

Given the elevated DKA risk in type 1 diabetes, blood ketone monitoring (not just urine dipstick) is strongly advised for any pediatric patient on empagliflozin. The American Diabetes Association's 2024 Standards of Care state: "Patients with type 1 diabetes treated with SGLT2 inhibitors should be counseled to monitor ketones regularly and to hold the medication during illness, surgery, or prolonged fasting" [7]. A blood beta-hydroxybutyrate target of below 0.6 mmol/L before meals gives a reasonable safety margin. Families need a written sick-day protocol that specifies exactly when to hold the medication and when to go to the emergency department.

Insulin Dose Adjustments

Starting empagliflozin typically requires a proactive basal insulin reduction of 10 to 20 percent to lower DKA risk from euglycemic ketoacidosis. This is especially relevant in the 10-to-12 age range where insulin sensitivity changes rapidly with growth spurts and pubertal hormones. A pediatric endocrinologist should supervise any insulin adjustment, not a primary care provider working alone.

What Is the Transition-to-Adult-Care Framework for Pediatric Empagliflozin Patients?

Transition from pediatric to adult endocrinology is one of the highest-risk periods for any child with a chronic endocrine condition. A child who starts empagliflozin at age 10 or 11 will likely still be on it when they transfer care. That handoff requires a structured, written plan, not a referral letter.

When Transition Typically Happens

Most pediatric diabetes centers in the United States initiate the formal transition process between ages 16 and 18, with transfer to adult care completed by age 21 at the latest. The American Diabetes Association and the International Society for Pediatric and Adolescent Diabetes (ISPAD) both recommend a gradual, staged transition rather than an abrupt handoff [7]. A child who starts empagliflozin at age 10 may go through 7 to 11 years of pediatric follow-up before transfer, meaning the adult endocrinologist inherits a patient with a full history of SGLT2 inhibitor exposure, DKA risk events, and potentially several dose adjustments.

The Six-Step Handoff Checklist for Empagliflozin Patients

The following framework covers the minimum documentation and clinical actions required when a pediatric empagliflozin patient transitions to adult care:

1. Medication reconciliation. Confirm current dose (2.5 mg vs. 5 mg), duration of use, and any prior dose changes due to DKA events or renal function changes.
2. DKA history summary. List every DKA or euglycemic DKA episode during pediatric care, including the precipitating factor and whether empagliflozin was held at the time.
3. Renal function trend. Provide at least 2 years of eGFR and urine albumin data so the adult nephrologist or endocrinologist can identify a trajectory, not just a single value.
4. Insulin regimen details. Document current basal and bolus insulin doses, any pump settings, and any CGM device in use, because SGLT2 inhibitor dosing interacts with all of these.
5. Sick-day protocol acknowledgment. Confirm in writing that the patient and family have received, reviewed, and understood the sick-day rules specific to empagliflozin in type 1 diabetes.
6. Adult provider orientation note. The pediatric team should send a one-page clinical summary that explicitly flags the empagliflozin-related DKA risk, the baseline renal parameters, and any prior cardiovascular screening results.

Psychosocial Readiness Matters

Transfer readiness is not only a clinical checklist. A 2021 systematic review in Pediatric Diabetes found that adolescents who scored lower on diabetes self-management scales were significantly more likely to experience glycemic deterioration in the 12 months following transfer to adult care [8]. A patient who cannot independently identify ketone symptoms or articulate when to hold empagliflozin should not be transferred until that gap is closed. Pediatric teams should use a validated readiness tool such as the Transition Readiness Assessment Questionnaire (TRAQ) at least 12 months before the planned transfer date.

What Are the Contraindications and Warnings Specific to Young Children?

Several contraindications and warnings carry heightened clinical weight in the under-12 population.

Absolute Contraindications

• eGFR <30 mL/min/1.73 m²: Empagliflozin is contraindicated. Renal glucosuria depends on adequate filtration; efficacy collapses and safety risks persist.
• History of serious hypersensitivity: Any prior reaction to empagliflozin or excipients contraindicates rechallenge.
• Active DKA: The drug must be held during any active ketoacidosis episode. Restarting requires physician clearance.
• Age under 10 years: No approved indication; off-label use is not supported by evidence and introduces unquantified risk.

Genital Mycotic Infections in Prepubertal Children

Empagliflozin's glucosuric mechanism creates a favorable environment for genital yeast infections. In prepubertal children, these infections may present atypically, appearing as vulvovaginitis or balanitis that is mistakenly attributed to poor hygiene. The pediatric prescribing information notes this risk, and families should be counseled to report genital symptoms promptly. In the Phase 3 pediatric trial, genital mycotic infections occurred more frequently in the empagliflozin arms than in the placebo arm [4].

Urinary Tract Infections

The glucosuria that defines SGLT2 inhibitor action also raises the risk of ascending urinary tract infections. Children under 12 are already at higher baseline UTI risk than adults, particularly girls. A UTI in a child on empagliflozin warrants prompt treatment and a brief medication hold until the infection resolves and ketone levels are confirmed normal [1].

How Does Empagliflozin Compare to Other Pediatric Diabetes Medications?

Families and clinicians considering empagliflozin for a child aged 10 to 11 should understand where it sits relative to established agents.

Empagliflozin vs. Metformin in Pediatric T2D

For type 2 diabetes in children aged 10 and older, metformin remains the preferred first-line oral agent per ADA guidelines, with over two decades of pediatric safety data. Empagliflozin offers an HbA1c reduction of similar magnitude (roughly 0.5 to 0.8 percentage points) but adds cardiovascular and renal benefits that have been demonstrated in adults. The TODAY2 follow-up data suggest that youth-onset type 2 diabetes progresses aggressively, which has prompted some pediatric endocrinologists to consider earlier SGLT2 inhibitor initiation. No head-to-head randomized trial has compared empagliflozin directly with metformin as initial therapy in pediatric type 2 diabetes as of early 2025 [6].

Empagliflozin vs. Other SGLT2 Inhibitors in Pediatric T1D

Dapagliflozin received FDA approval for type 1 diabetes in adults in 2019, though that approval was subsequently withdrawn in the United States after the FDA declined to expand it, citing DKA risk. Canagliflozin does not carry a type 1 diabetes indication. Empagliflozin at 2.5 mg is currently the only SGLT2 inhibitor with an active FDA label for type 1 diabetes in children aged 10 and older in the United States [1]. That distinction matters when insurers or pharmacists question the indication.

What Should Families Ask at Every Appointment?

Communication gaps between pediatric teams and families are the most common failure point in managing empagliflozin in young children. At every appointment, families should raise four questions: Is the current dose still appropriate given recent growth and renal function? Has ketone monitoring frequency been reviewed? Is there a documented sick-day protocol in the medical record? And is the transition plan in writing, with a target transfer date?

The Endocrine Society's clinical practice guidelines on pediatric diabetes management note that structured self-management education, delivered at least annually, is associated with better glycemic outcomes across all medication classes [9]. Empagliflozin does not change this principle; it intensifies it. The drug's DKA risk means a family without a solid sick-day plan is not ready for the medication, regardless of the child's age.

What Happens to Empagliflozin Dosing After the Child Turns 18?

When a patient transfers to adult care, the 2.5 mg pediatric starting dose does not automatically change. Adult dosing for type 1 diabetes (where applicable under a physician's clinical judgment, since the adult T1D indication path is complex in the US) or type 2 diabetes uses 10 mg once daily as the standard starting dose, with 25 mg available for additional benefit. An adult endocrinologist inheriting a patient on 2.5 mg or 5 mg from pediatric care should review whether a dose increase is clinically appropriate based on eGFR, body weight, glycemic targets, and DKA risk history. A transition period of at least 3 months with the original dose before any increase is reasonable, giving the new care team time to establish a baseline [1].

The EMPA-REG OUTCOME trial demonstrated a 14% reduction in major adverse cardiovascular events with empagliflozin in adults with type 2 diabetes and established cardiovascular disease [3]. For the young adult who started empagliflozin at age 10 and carries it into adulthood, this long-term cardiovascular benefit becomes an increasingly relevant reason to continue therapy, provided renal function remains adequate. An eGFR checked at least annually in the adult years lets the prescribing team confirm that the drug's efficacy and safety profile remain intact.